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22 January 2026: Clinical Research  

Manipulator-Free Versus Manipulator-Assisted Total Laparoscopic Hysterectomy: Are Outcomes Comparable in Experienced Hands?

Baki Erdem ABF 1, Sezgi Güllü Erciyestepe ABCEF 1*

DOI: 10.12659/MSM.949649

Med Sci Monit 2026; 32:e949649

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Abstract

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BACKGROUND: Total laparoscopic hysterectomy (TLH) is a minimal invasive procedure for benign, premalignant and early-stage malignant uterine conditions. Uterine manipulators are commonly used to facilitate uterine mobilizations and improve surgical exposure, but their necessity and potential impact on intraoperative and postoperative complications remain debated. Despite conflicting findings, evidence from large retrospective cohorts comparing manipulator-assisted versus manipulator-free TLH remains limited. The aim of this study is to compare intraoperative and postoperative outcomes of TLH performed with and without using uterine manipulators.

MATERIAL AND METHODS: A retrospective cohort analysis of consecutive TLH for benign, premalignant, and early-stage endometrial cancer indications was conducted. Patients were categorized by uterine manipulator use (manipulator group, n=244; manipulator-free group, n=166). Demographics, uterine weight, operative time, hemoglobin change, intraoperative injuries, and postoperative complications were extracted from electronic records. Statistical comparisons were performed using chi-square or Mann-Whitney U tests (P<0.05).

RESULTS: Baseline characteristics were comparable between the groups. Mean uterine weight was 349.55±324.35 g (range 44-1354 g) in the manipulator group and 356±324.42 g (range 47-1440 g) in the non-manipulator group (P=0.842). Mean operative time did not differ significantly (79.6±26.07 vs 76.6±25.16 min; P=0.259). Intraoperative complications, vaginal lacerations, postoperative complications rates (13.9% vs 12.7%; P=0.708), hemoglobin changes, and hospital stay were comparable. Vaginal cuff hematomas were rare and similar between groups; no dehiscence occurred.

CONCLUSIONS: Expert laparoscopic surgeons can safely perform TLH without the use of a uterine manipulator. This approach does not appear to increase the risk of morbidity, compared with the use of a manipulator.

Keywords: Hysterectomy, Laparoscopy

Introduction

Total hysterectomy remains one of the most frequently performed gynecological surgical procedures. While it was initially performed via abdominal and vaginal approaches, laparoscopic techniques gained popularity from the late 1980s onward [1]. In recent years, minimally invasive surgery has become more available and has become the standard for benign conditions [2]. The shift toward laparoscopy was driven by advantages such as lower postoperative morbidity, faster return to normal activities, and improved cosmetic outcomes than with the abdominal approach [3].

In total laparoscopic hysterectomy (TLH), cephalad uterine manipulation facilitates perpendicular dissection of the uterine vessels, elevation and exploration of the rectouterine pouch, and identification of the vaginal fornices [4]. Uterine manipulators are surgical devices inserted transvaginally into the uterine cavity to provide controlled mobilization and positioning of the uterus. Uterine manipulators are frequently used to facilitate uterine mobilization, aiding exploration and maintaining distance from vital structures [5]. This use in TLH has been advocated for preventing urinary system injury [6]. However, despite this, ureteral injury incidence in TLH remains at 0.5% to 1%, with a significant proportion of injury occurring during procedures using manipulators [7]. A study examining ureteral injuries revealed that manipulators were used in 83.9% of cases, suggesting that they are not the ultimate or most significant factor in preventing ureteral and other organ or vascular injuries [8]. Conversely, uterine manipulators are associated with complications such as uterine rupture, bowel penetration, vaginal wall and cervical laceration, manipulator disintegration, and cup melting [4]. Furthermore, cost, requirement for a second assistant, increased learning curve for the second assistant, difficulty maintaining pneumoperitoneum, and limited uterine movement represent additional disadvantages and limitations [4,5]. Conditions such as vaginal stenosis, nulliparity, and large uterine size can hinder the use of the uterine manipulators or increase the risk of complications [7,9]. Finally, although some studies have reported contradictory findings [10–12], concerns regarding the potential for retrograde dissemination of malignant cells in early-stage cervical and endometrial cancers with manipulator use have been raised [13,14].

Kavallaris et al (2011) described a manipulator-free TLH technique [7]. This technique offered acceptable operation duration and a short postoperative recovery period (3.5 days) without the complications and limitations associated with manipulators. The authors reported that the technique was safe in the hands of experienced surgeons, including cases with large uteri (1480 g), vaginal stenosis, small cervix, and early-stage endometrial and cervical cancer. Subsequent studies have also demonstrated manipulator-free TLH as a suitable approach with acceptable operation duration, even in cases with large uteri [11,15,16]. However, comparative studies assessing intra- and postoperative outcomes, such as ureteral and bladder injuries, operation duration, and length of hospital stay, in manipulator-free versus manipulator-assisted TLH remain limited [4,5]. The present study is designed to address this gap by retrospectively analyzing the outcomes of patients undergoing TLH with and without the use of uterine manipulators.

Material and Method

SETTING, PATIENTS, AND DESIGN:

This retrospective cohort study is a single-center, retrospective observational study conducted at the Department of Obstetrics and Gynecology in a private tertiary hospital. Ethics approval was obtained from Acıbadem ATADEK Review Board (approval No: 2025–06/245, dated April 17, 2025). Written informed consent for surgical procedures and anonymized data use was secured from all participants. The study was conducted following principles of the Declaration of Helsinki.

The study population included patients undergoing TLH performed by the same surgical team between May 2018 and September 2023. The surgeon possessed 6 years of experience as a gynecologic oncologist and 14 years of experience in laparoscopic surgery. Patients were stratified into 2 groups based on the use of uterine manipulators during TLH: a control group (TLH with manipulators) and a study group (manipulator-free TLH). Patient demographics (age, weight, body mass index [BMI], and prior surgical history) were extracted from the hospital’s electronic medical records. Hysterectomy indications, surgical data, and intraoperative and postoperative complications were systematically collected and analyzed. Women undergoing TLH for benign indications, such as fibroids, adenomyosis, and abnormal uterine bleeding, and selected early-stage endometrial carcinoma (FIGO stage IA, grade 1–2 endometrioid histology) were eligible. Exclusion criteria included cervical cancer, ovarian malignancies beyond stage I, stage III–IV endometrial cancer, and pelvic organ prolapse grades III and IV. The primary reason of the exclusion was that these cases were considered longer operations with more complications and could cause bias in the study. Thus, the exclusion criteria included prior extensive pelvic surgery with dense adhesions, uterine weight >1000 g, severe cardiopulmonary comorbidity, concurrent adnexal malignancy, or incomplete records.

OBJECTIVES AND OUTCOMES:

Manipulator-free and manipulator-assisted TLHs were compared with respect to operation duration, length of hospital stay, pre- and postoperative hemoglobin difference, frequency of intraoperative complications, such as ureteral, bladder, and bowel injuries, vaginal/perineal lacerations, conversion to open abdominal surgery, and blood transfusion; and frequency of general postoperative complications, such as urinary tract infections and postoperative fever, vaginal vault dehiscence, and vaginal cuff hematoma. Primary outcomes were considered as the intraoperative and postoperative (<30 days) complication rates, which were stratified by severity using the Clavien–Dindo classification. Secondary outcomes were operative time (skin incision to closure), estimated blood loss (direct intraoperative measurement, supplemented by perioperative hemoglobin change), conversion to laparotomy, and length of hospital stay.

METHODS:

All patients were admitted to the hospital the day before surgery. A comprehensive medical history and physical examination were performed, including assessment of hepatic and renal function, and pelvic and urinary tract ultrasonography. Oral intake was withheld for 8 h prior to surgery; no further bowel preparation was implemented. Intraoperative antibiotic prophylaxis with 1.5 g intravenous cefuroxime was administered to all patients. Postoperative tromboprophylaxis was initiated 12 h after surgery and continued until discharge. Early mobilization was encouraged, with patients ambulating 6 h after surgery. A complete blood count was obtained at 24 h after surgery. Transurethral catheters were removed upon achieving full patient mobility. Routine drainage was not used. All procedures were performed by the same surgical team using a consistent surgical technique.

Preoperative characteristics, including age, weight, BMI, parity, and relevant medical history were recorded for comparative analysis. Postoperative data collected included intraoperative and postoperative complications, length of hospital stay, estimated blood loss (calculated as the difference in preoperative and 24-h postoperative hemoglobin levels, reported in g/L), and uterine weight.

SURGICAL PROCEDURE:

The patient was placed in the low lithotomy position with both arms secured. The abdomen and vagina were prepared and draped using antiseptic solution. In manipulator-assisted cases, the cervix was exposed using a speculum or vaginal valve and dilated to a size 7 Hegar dilator. A small, medium, or large uterine manipulator was then inserted into the uterine cavity, sized appropriately for the cervix. The V-care laparoscopic uterine manipulator was used for the manipulator-assisted cases. For manipulator-free cases, 1 or 2 sponges were placed within a sterile surgical glove. The glove was tied off, molded into a rounded mass, and introduced into the vagina using an ovum forceps. A 10-mm umbilical trocar was used for initial pneumoperitoneum establishment (at a more superior point for large uteri, especially in manipulator-free cases). A 30-degree laparoscope was used. Two additional 5-mm trocars were placed, 1 superior and lateral to the left anterior superior iliac spine, and 1 on the left lateral abdominal wall. A third 5-mm trocar was placed superior and lateral to the right anterior superior iliac spine (Figure 1). For a bigger uterus, it is better to consider slightly higher ports to restore working angles and keep inter-port spacing >7 cm to avoid facing. Bipolar electrocautery and LigaSure were used for hemostasis.

The initial step involved transection of the round ligaments. In Figure 2, careful mobilization techniques are shown. Exposure in manipulator-free TLH was optimized using a combination of patient positioning (steep Trendelenburg), strategic port placement (Figure 1), and a transabdominal fundal suspension (uterine hitch). A seromuscular suture was placed in the uterine fundus and exteriorized through the anterior abdominal wall to provide stable cephalad traction. Dynamic 2-handed laparoscopic traction (dominant and assistant graspers) and a right lateral assistant port were used to lateralize adnexal structures and sequentially expose uterine pedicles. Bladder decompression with a Foley catheter and careful reflection of the vesicouterine fold allowed safe colpotomy and vaginal cuff exposure (Figure 2). In patients undergoing oopherectomy, the infundibulopelvic ligament was divided; otherwise, the ligamentum ovarii proprium was transected. Bladder dissection was then performed. In manipulator-assisted cases, cephalad traction of the manipulator facilitated visualization of the vaginal vault and mobilization of the bladder. In manipulator-free cases, manipulation of the intra-vaginal sponge (Figure 3) facilitated bladder dissection and uterine separation from the vagina. A “cervical hitch” stitch placed via the vagina could substitute for a manipulator by providing cephalad traction on the cervix/uterus, improving exposure of the anterior cul-de-sac, uterosacral complex, and adnexa (Figure 4). Subsequent steps included uterine artery ligation and transection, and cardinal ligament transection. The vagina was incised using a monopolar hook cautery, and the specimen was removed through the vagina. Following manipulator removal, in manipulator-assisted cases, a sponge-filled surgical glove was packed into the vagina to prevent gas leakage. In manipulator-free cases, the same sponge-filled glove was replaced into the vagina after specimen removal. The vagina was closed using a continuous 2–0 V-Loc suture. Finally, the fascia and skin were closed, completing the procedure.

STATISTICAL ANALYSIS:

Continuous demographic and clinical variables – age, parity, number of prior abortions, BMI, operative time, duration of urinary catheterization, length of hospital stay, uterine weight, and change in hemoglobin levels from pre-to postoperative periods – are summarized using descriptive statistics, including mean±standard deviation, median, minimum, and maximum values. The following categorical variables are presented as frequencies and percentages: menopausal status, history of prior surgeries, indication for TLH, conversion to open laparotomy, need for blood transfusion, ureteral, bladder, bowel, and vaginal injuries, occurrence of fever (≥37.5 °C), vaginal cuff hematoma, vaginal cuff dehiscence, surgical site infection, deep vein thrombosis, urinary tract infection, and atelectasis, hospital stay ≥2 days, and catheterization duration ≥2 days. Prior to group comparisons, the normality of continuous variables was assessed using the Shapiro-Wilk test and visual inspection of Q-Q plots. Variables that deviated from normality were analyzed using the Mann-Whitney U test for non-parametric comparisons. Continuous variables with skewed distributions are presented as median and interquartile range (IQR), whereas normally distributed variables are reported as mean±SD. Categorical variables were compared using chi-square or Fisher exact tests as appropriate. Multiple endpoints were analyzed; to account for the increased risk of type I error, effect sizes and 95% confidence intervals are reported for all comparisons. No formal adjustment for multiple comparisons was applied, and secondary or exploratory outcomes are interpreted as supportive rather than definitive.

All statistical analyses were performed using SPSS version 20.0 (IBM Corp, Armonk, NY, USA). A P value less than 0.05 was considered statistically significant.

A power analysis was conducted to determine the required sample size for detecting a statistically significant difference in complication rates between 2 independent groups: patients undergoing TLH with a uterine manipulator versus without a uterine manipulator. Based on previous literature [7], we assumed a complication rate of 0.5% in the non-manipulator group and 5% in the manipulator group. Using a 2-tailed test with a significance level (α) of 0.05 and a statistical power of 80% (β=0.20), the required sample size was calculated to be approximately n=164 per group. The calculation was performed using the statsmodels power analysis module in Python, based on Cohen’s h effect size for proportions. Given the retrospective cohort sizes actually available (manipulator-free TLH, n=166; manipulator-assisted TLH, n=244), we performed power and precision calculations to clarify the study’s sensitivity. Assuming a baseline 30-day complication rate of 13% in the comparator group, the 2-sample normal approximation indicates the cohort can detect an absolute difference of approximately 8.3 percentage points (13.0% → 4.8%) in the direction of improvement, or approximately 10.6 percentage points in the direction of worsening, with 2-sided α=0.05 and 80% power. The 95% confidence interval half-width for a 13% proportion is ±5.1 percentage points (n=166) and ±4.2 percentage points (n=244). For continuous secondary outcomes, and using representative SDs (operative time σ approximately 35 min; estimated blood loss σ approximately 110 mL; length of stay σ approximately 0.7 day), the current sample is sufficiently powered to detect differences of approximately 9.9 min in operative time, approximately 31 mL in blood loss, and approximately 0.20 day in length of stay (2-sided α=0.05, power=80%). Because the study is retrospective with fixed group sizes, we report effect sizes and 95% confidence intervals rather than post-hoc power.

Results

A total of 421 patients who underwent TLH met the inclusion criteria. Eleven patients were excluded due to incomplete medical records. The final study population consisted of 244 (59.5%) patients in the manipulator-assisted TLH group and 166 (40.5%) patients in the manipulator-free TLH group.

Table 1 presents the demographic characteristics of the study cohort. No significant differences were observed between the manipulator-assisted and manipulator-free TLH groups regarding age (median 51 years in both groups), BMI (median 27 kg/m2 in both groups), or parity (median 2 in both groups (approximately 50% in each). A history of prior abdominal surgery (laparotomy or cesarean delivery) was reported in 45.9% (112/244) of patients in the manipulator-free group. Salpingo-oophorectomy was the only additional procedure performed in both groups. The most prevalent indication for hysterectomy was uterine fibroids in both cohorts. Malignant indications were present in 14.8% (36/244) of the manipulator-assisted group and 20.1% (33/166) of the manipulator-free group. Within the manipulator-assisted group, 8.2% (20/244) of cases involved early-stage endometrial cancer and 6.6% (16/244) involved carcinoma in situ. In the manipulator-free group, these figures were 9.9% (16/166) and 10.4% (17/166), respectively. Two patients in the manipulator-free group and 1 patient in the manipulator-assisted group underwent TLH with salpingoopherectomy secondary to BRCA1 mutations. In summary, the 2 groups were well-matched with respect to baseline demographics, frequency of concomitant procedures, and underlying indications for hysterectomy (Table 1).

Median uterine weight (190 g; IQR, 44–1354 g) and operative time (80 min; IQR, 40–140 min) in the manipulator-assisted TLH group were comparable to those observed in the manipulator-free TLH group (median uterine weight, 179 g; IQR, 47–1440 g; median operative time, 70 min; IQR, 40–141 min). The median change in hemoglobin concentration from preoperative to 24-h postoperative values was identical in both groups (0.50 g/dL); however, the ranges differed slightly, with 0.50–3.00 g/dL in the manipulator-assisted group versus 0.50–4.00 g/dL in the manipulator-free group. No statistically significant differences were identified between groups with respect to uterine weight, operative time, or perioperative hemoglobin change (Table 2).

Minor vaginal lacerations requiring intraoperative repair were observed in 2 patients within each cohort. A single case of genitourinary fistula formation secondary to iatrogenic urinary tract injury occurred in both groups. Of note, the patient in the manipulator-free group who developed a vesicovaginal fistula had a significantly larger uterus (1100 g); similarly, the patient in the manipulator-assisted group who experienced a uretero-vaginal fistula also presented with a large uterus (1200 g) (Table 3). Importantly, no instances of bowel or vascular injury necessitated conversion to open laparotomy. Intraoperative transfusion requirements were comparable between groups (Table 3), limited primarily to patients exhibiting pre-existing low hemoglobin levels.

Postoperative complications were prospectively monitored for 6 weeks. The overall complication rate was comparable between groups, with 13.9% (34/244) of patients in the manipulator-assisted group and 12.7% (21/166) in the manipulator-free group experiencing at least 1 complication (P=0.708). Major complications (Clavien-Dindo >III) occurred in 3.4% versus 3.1% in the manipulator-assisted and manipulator-free groups, respectively. Atelectasis was the most prevalent early postoperative complication in both cohorts. Urinary tract infections occurred with similar frequencies and were the most common cause of postoperative pyrexia, often in association with atelectasis. Four patients in the manipulator-assisted group and 2 in the manipulator-free group required blood transfusions; all 6 patients had preoperative hemoglobin levels below 10 g/dL and underwent surgery for uterine fibroids. Hospital stays exceeding 2 days were exclusively observed in patients who developed early postoperative complications.

No cases of vaginal cuff dehiscence were reported. Vaginal cuff hematomas developed in 5 patients in the manipulator-assisted group and 2 in the manipulator-free group, with 1 patient requiring drainage in the manipulator-assisted group. All hematomas resolved spontaneously within 3 to 4 weeks. Symptomatic pyrexia was managed with paracetamol.

Discussion

In this retrospective comparative study, we evaluated the intraoperative and postoperative outcomes of 244 manipulator-assisted and 166 manipulator-free TLHs performed by a single, high-volume surgeon. Baseline demographics, hysterectomy indications, and the need for concomitant procedures were comparable across both cohorts. Benign pathology predominated, although the incidence of malignant indications, primarily early-stage endometrial carcinoma (FIGO stage I), was similar between groups. No significant intergroup differences were observed in uterine weight, operative time, perioperative hemoglobin change, or length of the hospital stay. Neither cohort experienced bowel or vascular injury, nor required conversion to laparotomy. A single instance of genitourinary fistula secondary to iatrogenic urinary tract injury occurred in each group. Postoperative complications, including vaginal cuff hematoma, pyrexia, and urinary tract infections, exhibited similar frequencies in both groups. These findings indicate that, for experienced surgeons, both the manipulator-assisted and manipulator-free TLH techniques yield comparable operative times and intraoperative and postoperative outcomes.

Although the literature includes several case series and studies describing manipulator-free TLH techniques, this study is, to the best of our knowledge, one of the few comparative analyses of manipulator-assisted and manipulator-free approaches. The retrospective design had inherent limitations. Notably, the 6-week follow-up period limited the comprehensive evaluation of mid- and long-term outcomes. Moreover, the results reflect the experience of a single surgical team and should be considered within this context.

The purported primary benefit of uterine manipulators in TLH centers is their role in preventing ureteral injury during uterine artery ligation via uterine lateralization and facilitation of perpendicular vessel dissection [4]. A Delphi consensus endorsed the prophylactic use of uterine manipulators in TLH to mitigate ureteral injury risk [6]; however, this recommendation was based on expert consensus rather than empirical evidence. Early studies hypothesized that cephalad manipulation of the uterus increases the ureter-cervix distance, thereby reducing the likelihood of ureteric injury [17]; however, this assertion was rooted in subjective observation and lacked objective data. Conversely, inappropriate cervical cup placement may diminish this distance [17]. While subsequent case reports provided some objective evidence supporting increased ureter-cervix distance with the use of a manipulator [4,6], ureteral injury remains a significant concern in TLH [5,7], with a substantial proportion documented in manipulator-assisted cases [8]. Beyond concerns regarding efficacy, uterine manipulators present several limitations, such as vaginal-cervical stenosis [7,9], challenges, such as cost and need of a second surgical assistant [4,5], and specific safety-related complications, including device disintegration, melting, organ injury, and potential for malignant cell dissemination [13–15]. By comparing minimally invasive surgery with open radical hysterectomy in early-stage cervical cancer, the LACC trial unexpectedly reported inferior oncological outcomes, showing a 6.6 times greater likelihood of death associated with minimally invasive surgery, and lower disease-free survival and overall survival in the minimally invasive surgery group (2).

Manipulator-free TLH, initially described in 2011 [7], currently lacks dedicated comparative studies with manipulator-assisted TLH regarding intraoperative and postoperative outcomes, particularly concerning urinary tract injury rates. The present retrospective comparison revealed a single case of urinary tract injury in each group, manifesting postoperatively as vaginal urinary leakage. The patient in the manipulator-free group, presenting with a 1100-g uterus, experienced leakage on postoperative day 7, prompting urinary catheterization; spontaneous fistula closure occurred within 2 weeks. This complication was attributed to either energy application or forceful uterine extraction. The patient in the manipulator-assisted group, also with a large uterus of 1200 g, developed urinary leakage on postoperative day 14. Computed tomography urography confirmed a uretero-vaginal fistula, which was managed with placement of a double-J ureteral stent. Stent removal at 3 months postoperatively confirmed complete resolution. Therefore, both cohorts demonstrated comparable and acceptable rates of urinary tract injury. These findings align with the available case series and retrospective studies [7,16,17]. One case series (n=57) describes a manipulator-free TLH technique, using laparoscopic instruments for parametrium lateralization [7]. Anterior vaginal dissection was undertaken using a combination of the surgeon’s fingers and laparoscopic scissors. After cervical luxation toward the abdomen, the cervix was visualized, and the vaginal wall and parametria were sharply dissected from the cervix. The authors reported no ureteral or bladder injuries in this series (mean uterine weight, 263 g; range, 35–1480 g), attributing this to their technique’s reduced ureteric injury potential [7]. A larger retrospective analysis (n=1023) using the Kavallaris manipulator-free TLH technique reported only 1 ureteral injury (0.09%) in patients with an average uterine weight of 255 g (40–1510 g). This single injury occurred in a patient with a 10-cm intraligamentary myoma and additionally included 3 bladder injuries and 5 superficial small bowel injuries, the latter attributed to dense adhesions [18]. Another study, analyzing 52 cases of manipulator-free TLH categorized by uterine weight (cutoff, >280 g), showed no ureteral, bladder, or bowel injuries reported in either group [18]. A more recent retrospective study comparing patients undergoing TLH for stage IB1-IIA1 cervical cancer with and without manipulators reported similar complication rates, without specific organ injury [11]. The only relevant randomized controlled study, the ROMANHY trial, assessing the role of uterine manipulators in laparoscopic/robotic hysterectomy for early-stage endometrial cancer, demonstrated no ureteral injuries and comparable intra- and postoperative complication rates between manipulator-assisted and manipulator-free groups; however, this was not the primary endpoint of the trial [20]. The present study’s findings, along with those of other studies, suggest that manipulator-free TLH, performed under optimal conditions, affords safe urinary tract injury rates. Our experience and the supportive literature suggest that manipulator use or avoidance is not the sole determinant of urinary injury risk in TLH [4].

Vaginal and perineal trauma are other potential complications of TLH, often occurring during uterine extraction in manipulator-free cases [21,22]. This study demonstrated no significant intergroup difference in intraoperative vaginal injury rate (0.8% in the manipulator-assisted group vs 1.2% in the manipulator-free group); all vaginal lacerations were definitively repaired intraoperatively. This rate aligns with that reported by Zygouris et al in a manipulator-free TLH series [19], yet it is lower than rates reported in some recent studies of manipulator-assisted TLH [20,21], although older studies reported similar rates [22].

Uterine dimensions can present mechanical challenges throughout the procedure, affecting exploration, TLH technique execution, and specimen extraction. A consensus regarding the definition of a “large uterus” in cases of fibroid-related or adenomyosis-related enlargement remains elusive. Bonilla et al demonstrated a correlation between uterine weight exceeding 500 g and increased complication rates and hospitalization duration in total abdominal hysterectomy and TLH [23]. However, these authors emphasized that this increase was more pronounced in total abdominal hysterectomy, highlighting the advantages of TLH over total abdominal hysterectomy. A recent study indicated that the risk of conversion to open surgery is not solely associated with uterine weight but also with the maximum size of the largest myoma (particularly those exceeding 10 cm in diameter), with surgeon experience representing another predictive factor [24]; this study, however, included TLH cases performed using uterine manipulators. Only case reports focus on manipulator-free TLH for large uteri. Maccio et al (2018) reported successful manipulator-free TLH in 2 patients with extremely large uteri weighing 5700 g (benign fibroid uterus) and 3670 g (lymphoproliferative disease) [9]. In the series by Kavallaris et al, the mean uterine weight was 263 g. The authors demonstrated that TLH could be performed without a uterine manipulator even with uterine weighs up to 1480 g [7]. In the series by Mebes et al, the mean uterine weight in the group with >280 g was 532 g (±252.51), and groups were similar in terms of intra- and postoperative outcomes [18]. In our study, mean uterine weights in the manipulator-assisted and manipulator-free TLH groups were 349.55±324.35 g and 355.59±324.42 g, respectively. Neither group required conversion to open surgery. Uteri weighing up to 1354 g (manipulator-assisted group) and 1440 g (manipulator-free group) were successfully removed without significant differences in operation duration, intra-and postoperative complications, or length of hospital stay. Therefore, uterine weight may not preclude TLH, regardless of uterine manipulator use.

Regardless of surgical approach, prolonged operative time is a major predictor of postoperative morbidity [25,26]. A direct and independent relationship has been demonstrated between operative time and 30-day postoperative complications in laparoscopic and robotic hysterectomy [27]. A literature review, based on the largest sample size series between 1997 and 2007, reported a mean TLH operative time of 83 to 136 min and mean blood loss of 313 mL (ranging from 50 to 1500 mL) [4]. Both outcomes correlated with uterine weight. A recent large national retrospective cohort (n=81 998 TLH) reported a mean TLH duration of 129±60 min. This same study indicated that TLH, regardless of operation duration (up to 360 min), was associated with lower major morbidity and shorter hospital stay, compared with total abdominal hysterectomy [25]. No randomized controlled trials directly compare operation duration, blood loss, and other outcomes between manipulator-assisted and manipulator-free TLH. In the manipulator-free technique, Kavallaris et al reported mean TLH durations of 50 to 92 min without salpingo-oophorectomy and 61 to 102 min with salpingo-oophorectomy, using bipolar coagulators, scissors, sonosurgery, and cutting forceps [7]. A large retrospective analysis evaluating manipulator-free TLH cases reported a mean duration of 75 (43–145) min without salpingo-oohorectomy and 83 (45–168) min with salpingo-oohorectomy [16]. In this present retrospective analysis of manipulator-assisted and manipulator-free TLH groups, median operative times were similar, at 80 min (40–140 min) and 70 min (40–141min), respectively. Operative times in both the manipulator-assisted and manipulator-free groups were comparable to the literature and well below thresholds associated with increased major morbidity risk. Variations in operation duration between cases or studies likely stem from case complexity and the presence of intraoperative complications rather than manipulator use. For instance, 9 of the 10 cases with the longest operative times in this study involved large fibroids and uterine weights exceeding 1000 g. Two ureteral injuries and 1 vaginal injury occurred within this subset of cases. Surgeon experience represents another potential contributing factor of operation duration. The present study includes only TLHs performed by a single surgeon, and we are aware of this as a limitation of the study. However, to compare the results of both techniques, we should rule out the differences in the surgeon’s experience. This is also why having a single surgeon was also the strength of the study, by minimizing inter-operator variability and standard outcome reporting. However, multicenter studies are needed to draw more concrete conclusions. The limitations of the present study are inherent in its retrospective, non-randomized design, risk of selection bias, and limited generalizability to low-volume settings. Larger multicenter prospective trails are needed to validate equivalence, particularly for oncologic outcomes.

TLH performed without the use of a manipulator can be safely applied, even in elderly patients with multiple comorbidities. Giannini et al reported that the fragility index was a reliable predictor of postoperative complications in patients with endometrial cancer [28]. In future studies, predictive models using this and similar indices may allow for more detailed comparisons of postoperative outcomes.

Conclusions

This study demonstrates that manipulator-free TLH presents a comparable operation duration, satisfactory postoperative recovery profile, and similar rates of intra- and postoperative complications to manipulator-assisted TLH. However, the influence of surgeon experience is a potential consideration. Given the established role of manipulators in accelerating the TLH learning curve, we advocate for the selective application of the manipulator-free technique by experienced surgeons. The manipulator-free approach may confer advantages in cases presenting cervicovaginal challenges, such as nulliparity or postmenopausal atrophy, since these cases are challenging for manipulator replacement. Further prospective studies with larger sample sizes are warranted to definitively establish the long-term benefits and risks of this approach.

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