Comparison of Transvaginal Natural Orifice Surgery (vNOTES) and Laparoscopic Tubal Ligation: Effects on Postoperative Pain, Sexual Functions, and Surgical Outcomes.

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Abstract

Introduction: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimally invasive technique that eliminates the need for abdominal incisions. Compared to conventional laparoscopy (CL), vNOTES may offer reduced postoperative pain and faster recovery. While laparoscopy is the standard method for bilateral tubal ligation (BTL), limited comparative data exist regarding vNOTES for this indication. Aim: To compare postoperative outcomes, pain levels, and sexual function following BTL performed via vNOTES versus CL.

Material and methods

This retrospective comparative study included 43 women who underwent elective BTL between September 2023 and December 2024 (vNOTES: n = 23; CL: n = 20). Pain was assessed using a visual analog scale (VAS) at 1, 6, and 24 hours postoperatively. Shoulder pain incidence, intra-abdominal pressure, need for intraoperative opioids, and 6-item Female Sexual Function Index (FSFI-6) scores were also evaluated. Operative time, blood loss, and length of hospital stay were recorded.

Results

All procedures were completed without major complications. VAS pain scores at all measured time points were significantly lower in the vNOTES group (P < .05). Shoulder pain occurred in 15% of vNOTES cases versus 85% in the CL group (P < .001). Intra-abdominal pressure and intraoperative opioid requirements were significantly lower in the vNOTES group (P .05).

Conclusions

vNOTES is a safe and effective alternative to CL for female sterilization. It offers significant benefits in terms of reduced early postoperative and shoulder pain, without negatively affecting sexual function or surgical safety. These findings highlight the potential advantages of vNOTES as a minimally invasive technique in gynecologic surgery.

Keywords

Female sexual function, Laparoscopy, Postoperative pain, Shoulder pain, Tubal ligation, vNOTES

Introduction

Minimally invasive surgical techniques have gained increasing popularity in the field of obstetrics and gynecology due to their proven benefits in enhancing patient comfort, accelerating recovery, and reducing perioperative morbidity.1,2 Among these, laparoscopic procedures have undergone significant evolution over the last three decades and are now considered the standard of care for various gynecologic surgeries.3,4 In recent years, natural orifice transluminal endoscopic surgery (NOTES) has emerged as an innovative extension of minimally invasive surgery. Specifically, the transvaginal variant—vaginal NOTES (vNOTES)—offers a scarless, transvaginal access route to the peritoneal cavity without the need for abdominal incisions.5,6 The vNOTES technique has shown promising results in a variety of procedures, including hysterectomy, adnexectomy, and pelvic organ prolapse repairs, providing not only improved cosmetic outcomes but also potential reductions in postoperative pain and faster return to daily activities.7 The United Nation estimates that 180 million couples have relied on surgical contraception to limit their families worldwide. An estimate of about 700.00 female sterilization procedures were performed each year.8 Traditionally performed via laparoscopy, bilateral tubal ligation (BTL) can also be accomplished using vNOTES. Preliminary studies suggest that vNOTES may result in lower intraoperative pressures, decreased gas-related shoulder pain, and reduced need for analgesics.9,10 Despite these proposed benefits, comparative data between vNOTES and conventional laparoscopy (CL) in the context of BTL are limited, and evidence on sexual function outcomes following transvaginal approaches remains inconclusive. Moreover, adoption of vNOTES is still restricted due to the need for specific surgical skills and access to specialized equipment, underscoring the importance of clinical evidence in guiding practice patterns. Therefore, the present study aims to compare vNOTES and CL for BTL in terms of preoperative, intraoperative, and postoperative outcomes, including pain scores, intra-abdominal pressure, surgical safety, and changes in sexual function.

Materials and methods

This retrospective comparative study was conducted between September 20, 2023 and December 1, 2024 with the approval of the ethics committee, ethics approval number: 422/29.04.2025. The study was carried out at a secondary-level public hospital, and written informed consent was obtained from all patients. Study Population This study included women aged 18 years or older who requested permanent surgical sterilization and had no pelvic organ prolapse greater than stage 2, as assessed by the Pelvic Organ Prolapse Quantification (POP-Q) system. Exclusion criteria were: current pregnancy, active pelvic infection, suspected pelvic malignancy, history of rectovaginal endometriosis, pelvic abscess, or lack of prior vaginal intercourse.11 Consistent with our institutional protocol and ACOG Committee Opinion No. 620, risk-reducing bilateral salpingectomy (BS) was offered as the preferred form of permanent contraception during preoperative counselling. However, all 43 women declined salpingectomy, citing a strong cultural/religious reluctance to removal of reproductive organs, and voluntarily elected BTL. Following comprehensive counseling, each participant voluntarily selected either the vNOTES or CL approach for tubal ligation. Participants were subsequently categorized into study groups based on their selected surgical technique. Baseline demographic and clinical characteristics including age, height, weight, body mass index (BMI), parity, and history of prior abdominal or pelvic surgery were documented for both groups. A priori power analysis was performed using G*Power software (version 3.1.9.7, University of Düsseldorf, Germany) to determine the minimum required sample size for detecting a clinically significant difference between the vNOTES and CL groups. Assuming a medium effect size (d = 0.5), a significance level (α) of 0.05, and a statistical power (1-β) of 0.80, the analysis indicated that at least 40 participants were needed. Ultimately, a total of 43 eligible women were included in the study: 23 in the vNOTES group and 20 in the CL group. Surgical Procedure All surgical procedures were performed by gynecologic surgeons with established proficiency in both CL and transvaginal NOTES (vNOTES). Preoperatively, each patient received a single dose of 2 g of intravenous cefazolin as antibiotic prophylaxis, in accordance with institutional infection control guidelines. All procedures were conducted under general anesthesia with the patient positioned in the lithotomy position and tilted in a 15–30° Trendelenburg angle. Postoperative instructions included abstaining from sexual intercourse for at least two weeks to facilitate vaginal healing and reduce the risk of infection. vNOTES Group A 2.5-cm posterior colpotomy was performed by incising the posterior vaginal mucosa to access the pouch of Douglas. A GelPOINT V-Path transvaginal access platform (Applied Medical, Rancho Santa Margarita, CA) was inserted to establish working channels. A standard 30° 10-mm laparoscope and conventional reusable laparoscopic instruments, including LigaSure (Medtronic, Minneapolis, MN) and graspers, were used to perform BTL. The fallopian tube was grasped at the midisthmic segment, approximately 2 cm from the uterine cornua. Two consecutive 8-second LigaSure cycles were applied, producing a 1.5-cm avascular seal > 5 mm in width, and the tube was transected between the seals. BTL was completed in the same fashion on both sides.11 CL Group Pneumoperitoneum was established via a 10-mm umbilical trocar, followed by insertion of two 5-mm accessory trocars under direct vision. A standard 30° 10-mm laparoscope and the same set of reusable laparoscopic instruments (LigaSure, graspers) were used. The fallopian tube was grasped at the midisthmic segment, approximately 2 cm from the uterine cornua. Two consecutive 8-second LigaSure cycles were applied, producing a 1.5-cm avascular seal > 5 mm in width, and the tube was transected between the seals. BTL was completed in the same fashion on both sides.12 Although LigaSure lacks a specific Food and Drug Administration indication for tubal sterilization, ex vivo studies report burst pressures around 380–400 mm Hg and lateral thermal spread restricted to ≈1 mm (≤1.5 mm) beyond the seal line. Compared with a standard 5-mm bipolar forceps, LigaSure creates a wider (>5 mm) and more uniform seal, eliminates clips or sutures, and, in our cohort, shortened operative time by a median of 3 minutes. Statistical Analysis All statistical analyses were conducted using IBM SPSS Statistics version 26.0 (IBM Corp., Armonk, NY). Descriptive statistics were presented as mean ± standard deviation (SD), median (interquartile range [IQR]), frequencies, and percentages. The normality of distribution for continuous variables was assessed using the Shapiro–Wilk test (for n < 50). For normally distributed continuous variables, comparisons between groups were performed using the independent samples t test; for non-normally distributed variables, the Mann–Whitney U test was applied. Categorical variables were compared using the χ2 test. A P-value < .05 was considered statistically significant. The 6-item Female Sexual Function Index (FSFI-6) is the short form of the original 19-item FSFI developed by Rosen et al.13 Each item represents a single domain—desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 30, with values < 21 discriminating women with sexual dysfunction with 85% sensitivity and 82% specificity. The short form demonstrates good internal consistency (Cronbach’s α = 0.79–0.86), excellent test–retest reliability (r = 0.95), and robust construct validity across multiple languages. In the validated Turkish version Cronbach’s α was 0.86 and the intraclass correlation coefficient 0.92. All participants in the present study completed the validated Turkish FSFI-6.

Results

This study evaluated the effectiveness and safety of vNOTES and CL for tubal ligation in preoperative, intraoperative, and postoperative periods. A total of 43 patients were included and divided into two groups: vNOTES (n = 23) and CL (n = 20). Mean patient age was 35 ± 5 years in the vNOTES group and 35 ± 4 years in the CL group, with no statistically significant difference (P > .05). Similarly, no significant differences were observed between the groups in terms of BMI, parity, and previous surgical history (P > .05 for all comparisons). The similarity of baseline demographic characteristics between the two groups contributes to the internal validity and reliability of the study findings. Detailed demographic data for both groups are presented in Table 1. Table 1. | Overall (n: 43) | vNOTES (n: 23) | CL (n: 20) | P | | |---|---|---|---|---| | Age | 35 ± 4 | 35 ± 5 | 35 ± 4 | .732 | | Height | 158 ± 6 | 158 ± 6 | 158 ± 7 | .962 | | Weight | 72 ± 11 | 73 ± 10 | 70 ± 11 | .313 | | BMI | 28.9 ± 4.8 | 29.5 ± 4.9 | 28.2 ± 4.6 | .365 | | Prev. surgery | |||| | None | 24 (56%) | 16 (70%) | 8 (40%) | .052 | | Present | 19 (44%) | 7 (30%) | 12 (60%) | | | Number of vaginal deliveries | 4 ± 2 | 4 (2) | 4 (4) | .901 | Values are presented as mean ± standard deviation or number (percentage). No statistically significant differences were observed between the groups (P > .05 for all variables). The mean operative time was 25 ± 8 minutes in the vNOTES group and 35 ± 14 minutes in the CL group; however, this difference did not reach statistical significance (P > .05). Similarly, mean intraoperative blood loss was 33 ± 14 mL in the vNOTES group and 34 ± 22 mL in the CL group, with no significant difference between them (P > .05). In contrast, intra-abdominal pressure was significantly lower in the vNOTES group (8 mmHg) compared to the CL group (12 mmHg), and this difference was statistically significant (P < .05). The requirement for intraoperative opioid analgesics was also significantly lower in the vNOTES group, by 5.62% (P < .05). Positive end-expiratory pressure (PEEP) values were similar between the groups, averaging 4 ± 1 cmH2O. These intraoperative outcomes and hemodynamic parameters are summarized in Table 2. Table 2. | Overall (n: 43) | vNOTES (n: 23) | CL (n: 20) | P | | |---|---|---|---|---| | Duration of surgery | 31 ± 12 | 25 (15) | 35 (25) | .065 | | Intraoperative blood lose (mL) | 33 ± 18 | 33 ± 14 | 34 ± 22 | .997 | | Opioid amount (mg) | 480 ± 202 | 420 (360) | 445 (320) | .893 | | PEEP | 4 ± 1 | 4 (0) | 4 (1) | .072 | | Intra-abdominal pressure | 10 ± 2 | 8 (0) | 12 (0) | P < .001 | Values are presented as mean ± standard deviation or number (percentage). A statistically significant difference was observed in intra-abdominal pressure and opioid requirement (P < .05). Other parameters showed no significant differences between groups. No postoperative complications were observed in either group. Visual analog scale pain scores at 1, 6, and 24 hours postoperatively were significantly lower in the vNOTES group compared to the CL group (P < .05). Postoperative shoulder pain was reported in 15% of patients in the vNOTES group and 87% in the CL group, indicating a significant relative reduction of 82.76% in shouler pain with the vNOTES technique (P .05). No postoperative complications were observed in either group. These postoperative outcomes are summarized in Table 3. Table 3. | Overall (n: 43) | vNOTES (n: 23) | CL (n: 20) | P | | |---|---|---|---|---| | Postop 1 (VAS) | 7 ± 2 | 5 (2) | 8 (2) | P < .001 | | Postop 6 (VAS) | 6 ± 2 | 4 (2) | 7 (1) | P < .001 | | Postop 24 (VAS) | 4 ± 1 | 3 (3) | 4 (2) | .093 | | Postop shoulder pain | |||| | None | 23 (53%) | 20 (87%) | 3 (15%) | P < .001* | | Present | 20 (47%) | 3 (13%) | 17 (85%) | | | Length of hospital stay (days) | 1 ± 0 | 1 (0) | 1 (0) | .581 | Values are presented as mean ± standard deviation or number (percentage). Statistically significant differences were observed in pain scores and shoulder pain incidence (P < .05). No significant difference was found hospial stay duration. FSFI-6 was used to evaluate sexual function before surgery and one-month postoperatively. There was no statistically significant difference between the vNOTES and CL groups in preoperative FSFI scores (P > .05). Similarly, postoperative FSFI-6 scores did not differ significantly between the groups (P > .05). Although both groups exhibited a decline in postoperative FSFI scores, the change was not statistically significant within or between the groups (P > .05). These findings indicate that neither surgical technique demonstrated superiority over the other in terms of impact on sexual function. These postoperative outcomes are summarized in Table 4. Table 4. | Overall (n: 43) | vNOTES (n: 23) | CL (n: 20) | P | | |---|---|---|---|---| | Preoprative FSFI | 22 ± 7 | 21 ± 7 | 23 ± 7 | .223 | | Postoperative FSFI | 15 ± 6 | 14 (8) | 13 (12) | .922 | Values are expressed as mean ± standard deviation. No statistically significant differences were observed within or between the groups in preoperative and postoperative FSFI-6 scores (P > .05).

Discussion

In this study, intra-abdominal pressure was found to be lower, postoperative pain scores were significantly reduced, and shoulder pain was markedly less in the vNOTES group compared to the CL group. However, no significant difference was observed between the two groups in terms of postoperative sexual function. In recent years, vNOTES has emerged as an advanced form of minimally invasive surgery and has gained popularity in gynecology. Initially applied in benign gynecological surgeries such as hysterectomy, it has also shown feasibility for adnexectomy, pelvic organ prolapse repair, and selected early-stage oncologic procedures.14,15 Its scarless nature, reduced postoperative pain, and shorter recovery times have contributed to greater patient acceptance.7 Although the mean operative time was shorter in the vNOTES group compared to the CL group, the difference was not statistically significant. This finding is consistent with previous literature. For example, Housmans et al reported that the vNOTES approach was associated with significantly shorter operative times compared to CL in benign gynecologic procedures.1 In terms of intra-abdominal pressure, vNOTES demonstrated a significant advantage (8 mmHg vs 12 mmHg; P < .05). Lower pressure levels are associated with less diaphragmatic irritation, leading to a reduction in shoulder pain and improved postoperative respiratory function. These benefits have been supported by other comparative studies.9,10 Postoperative pain outcomes in this study also favored vNOTES. Pain scores at 1, 6, and 24 hours were significantly lower compared to the CL group, aligning with findings by Yassa et al, who reported improved early recovery and higher patient satisfaction with vNOTES.16 Sexual function was evaluated using the FSFI-6 scale before and one month after surgery. Although both groups showed a mild postoperative decline, the changes were neither statistically nor clinically significant. These findings are consistent with previous work by Halisçelik et al, suggesting that vNOTES does not negatively affect sexual function in the short term.17 Nonetheless, long-term follow-up is needed to evaluate possible delayed effects, especially in sexually active premenopausal women. Another notable finding was the reduced need for intraoperative opioid analgesics in the vNOTES group. This may reflect lower pain perception and greater procedural comfort. Given the increasing emphasis on Enhanced Recovery After Surgery (ERAS) protocols, such opioid-sparing techniques may be especially valuable.9 Despite its advantages, the routine use of vNOTES remains limited due to the need for specialized instruments and training, as well as a relatively steep learning curve.18 In our study, all procedures were performed by surgeons who had surpassed the learning curve, minimizing operator-related bias. Still, generalizability to less experienced settings may be limited. The main limitations of this study are its retrospective design and relatively small sample size, which reduce statistical power and external validity. Moreover, the one-month follow-up may not be sufficient to assess long-term outcomes, particularly in sexual function. Prospective randomized controlled trials with larger patient populations and extended follow-up periods are needed to validate and extend these findings.

Conclusion

Although evidence on the long-term outcomes of vNOTES remains limited, the findings of this study suggest that vNOTES is a safe and effective alternative to CL for BTL. It offers distinct advantages, including significantly lower intra-abdominal pressure, reduced postoperative pain, and decreased incidence of shoulder pain—without compromising surgical efficacy or short-term sexual function. To confirm these results and better understand the long-term impact of vNOTES, especially on pelvic health and sexual function, larger prospective randomized controlled trials with extended follow-up are warranted. Footnotes Disclosure: none. Conflict of interests: none. Funding sources: none.

Acknowledgement

The authors thank the surgical team and nursing staff of Iğdır Dr. Nevruz Erez State Hospital for their support during the study. We also appreciate the contributions of the ethics committee members for their guidance and approval of the research protocol. Contributor Information Mehmet Genco, Department of Obstetrics and Gynecology, Kayseri City Hospital, Kayseri, Türkiye. (Dr. Genco). Merve Genco, Department of Obstetrics and Gynecology, Kayseri State Hospital, Kayseri, Türkiye. (Dr. Genco). Feyza Azmak Çinaz, Department of Department of Anesthesiology and Reanimation Akhisar State Hospital, Manisa, Türkiye. (Drs. Azmak Çinaz and Çinaz). Semih Çinaz, Department of Department of Anesthesiology and Reanimation Akhisar State Hospital, Manisa, Türkiye. (Drs. Azmak Çinaz and Çinaz).

References

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