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Comparison of rapid recovery outcomes between vNOTES hysterectomy and laparoscopic hysterectomy: a prospective study

Abstract

Background

This study was aimed at evaluating the postoperative outcomes of vaginal natural orifice transluminal endoscopic hysterectomy (vNOTEH).

Methods

This prospective cohort study was conducted for comparing recovery outcomes, the time to first anal exhaust and return-to-work (RTW) time in vNOTEH versus laparoscopic hysterectomy (LH) groups. Linear regression analysis and cox proportional hazards regression were employed for analyzing the association between the recovery outcomes and surgical procedures.

Results

Altogether 330 patients were enrolled, with 92 in vNOTEH group whereas 238 in LH group according to the surgical procedure. Among them, 22 patients undergoing vNOTEH and 76 patients receiving LH returned to work. The operation time, the first anal exhaust time, RTW time, postoperative hospitalization of vNOTEH group remarkably decreased relative to LH group (P<0.05). Linear regression analysis indicated that the vNOTES approach was related to the time to first anal exhaust. Besides, Kaplan-Meier curve demonstrated the shorter median time to first anal exhaust in vNOTEH group than that in LH group (48.0 h vs. 69.0 h, P < 0.001). For patients who returned to work, multivariate Cox logistic regression revealed that surgical approach and postoperative hospitalization were significantly related to the RTW time. Furthermore, Kaplan-Meier curve showed that the median RTW time significantly decreased in vNOTEH subgroup relative to that in LH subgroup (2.0 months vs.3.0 months, P = 0.011).

Conclusions and relevance

vNOTES in women might be advantageous in the earlier recovery of intestinal function and the earlier return to work after hysterectomy compared with laparoscopy.

Trial registration

This study has been registered at https://www.chictr.org.cn with registration NO. ChiCTR2200063125 on Sep 27, 2022. The minimal postoperative follow up period was 1 month.

Peer Review reports

Introduction

Female patients diagnosed with high-grade cervical intraepithelial neoplasia (CIN II-III) often require surgical intervention, particularly for those developing concurrent uterine fibroids or adenomyosis [1]. These patients, who are typically younger and actively engaged in family and societal roles, are in urgent need of rapid postoperative recovery to minimize the disruptions to their daily lives [2, 3]. Postoperative recovery metrics, including the time to first anal exhaust and the return-to-work (RTW) time, are critical indicators for functional recovery and are highly valued by both surgeons and patients [4, 5]. The time to first anal exhaust, an essential marker of gastrointestinal recovery, reflects the restoration of bowel function [6,7,8]. Similarly, the time to return to work, closely tied to social and mental well-being, serves as a key measure of overall surgical recovery [5, 9, 10]. The prolonged recovery time can significantly impact the quality of life in young females and impose great social costs because of the lost productivity [5]. Thus, identifying surgical approaches that facilitate rapid postoperative recovery is of paramount importance for patients undergoing hysterectomy.

Laparoscopic surgery becomes the mainstream procedure for treating benign gynecological diseases [11]. Recently, vaginal natural orifice transluminal endoscopic surgery (vNOTES) has emerged as the promising third-generation surgical procedure, which is built on principles of minimally invasive surgery [12]. Unlike traditional laparoscopy, vNOTES utilizes the vaginal canal to insert a single-port platform, allowing laparoscopic instruments to access the abdominal cavity and perform complex procedures [12, 13]. This innovative approach has been successfully applied in various gynecological surgeries, including adnexal surgery, myomectomy, hysterectomy, and rectal prolapse repair, and offers patients a minimally invasive, painless, and scarless alternative [14].

vNOTES was first suggested to be feasible and safe for hysterectomy in one study involving 16 patients with benign uterine conditions in 2012 [15]. Subsequent studies, including a randomized controlled trial (RCT), confirm that vNOTES hysterectomy can be comparable to traditional laparoscopy, with no need of conversion to laparotomy [16]. Notably, vNOTES has demonstrated advantages over laparoscopy in cases involving large uteri (> 280 g), like the decreased operation time, the shortened hospital stays, and the improved ambulatory performance [12, 17]. However, the impact of vNOTES on specific recovery outcomes, such as the time to first anal exhaust and the time to return to work, remains unknown, particularly in high-grade CIN patients with concurrent benign conditions like fibroids or adenomyosis.

This study focused on the high-grade CIN patients with or without uterine fibroids/adenomyosis, a subgroup chosen due to their heightened need for rapid recovery. These patients usually balance tremendous familial and societal responsibilities, making efficient postoperative recovery essential. Additionally, the presence of benign conditions may increase the surgical complexity, underscoring the relevance of exploring minimally invasive techniques like vNOTES. Through prospectively analyzing this cohort, we aimed to evaluate the associations between vNOTES and recovery outcomes and identify the factors influencing these outcomes.

Methods

Patients

From September 2022 to December 2023, we prospectively collected data from all the consecutive women diagnosed with CIN II-III with or without uterine fibroids or adenomyosis who underwent vaginal natural orifice transluminal endoscopic hysterectomy (vNOTEH) or laparoscopic hysterectomy (LH) with or without uni- or bilateral oophorectomy at Affiliated Nanchong Central Hospital of North Sichuan Medical College. Patients were assigned in vNOTES or laparoscopy procedure based on their preference, surgeon expertise, and instrument availability, ensuring a pragmatic approach reflective of real-world clinical practice. Patients were categorized into the vNOTEH group or the LH group according to the surgical approach. To analyze the return-to-work outcomes, all the working patients were included, and censoring was applied to those who had not returned to work after follow-up (Fig. 1).

Fig. 1
figure 1

Flowchart of patient selection

Patients below were included: (1) those with high-grade CIN with or without uterine fibroids or adenomyosis who were unwilling to preserve their uterus and were scheduled for vNOTEH or LH due to benign uterine disease; (2) patients who were employed and satisfied with their work and life; (3) patients who underwent pelvic ultrasound, MR imaging, or histopathology and were indicated for surgical procedures; 3) patients assessed according to the American Society of Anesthesiologists (ASA) classification; 5) patients pathologically confirmed to have CIN with or without uterine fibroids or adenomyosis after surgery; 6) patients with complete baseline clinical information and surgical parameters (from medical records); and 7) patients willing to undergo postoperative follow-up.

Patients below were excluded: (1) those who were scheduled for laparotomy; (2) patients who were unemployed or dissatisfied with their work or life; (3) patients with a pelvic inflammatory disease history, obliterated pouch of Douglas upon clinical examination, active lower genital tract infection, known or suspected malignant diseases, rectovaginal endometriosis, a rectovaginal endometriosis surgery or rectal surgery history, or pelvic radiotherapy; and 3) patients who refused postoperative follow-up.

Surgical technique

All the surgical interventions were co-led by two board-certified gynecologic surgeons (Hui-quan Hu, MD, with 37 years of laparoscopic expertise; Yue-xi Luo, MD, with 36 years of subspecialty experience) at our tertiary referral center. To standardize the surgical quality, blinded assessments of two unedited laparoscopic videos were conducted by the independent trial steering committee using the LAP-VEGaS competency framework, with supplementary analysis of 30-day postoperative outcomes (complication rates, readmission rates) to confirm the inter-surgeon consistency (Cohen’s κ = 0.89) [5, 18]. Our standardized protocols incorporated three evidence-based pillars: (1) the WHO Surgical Safety Checklist (2019 revision) [19]; (2) the Association of Operating Room Nurses (AORN) guidelines for perioperative normothermia management [20]; and (3) the Active patient warming with forced-air systems (3 M™ Bair Hugger™, Model 775) maintaining core temperature ≥ 36 °C [21]. Preoperative optimization was completed following the enhanced recovery after surgery (ERAS) principle, and general anesthesia was administered via video-laryngoscope guided intubation. Each patient was placed in the standard lithotomy position recommended by the International Federation of Gynecology and Obstetrics (FIGO) using gel-padded stirrups, and a 25° Trendelenburg tilt was maintained during surgery [22]. The operating room implemented the three-tier quality controls [23]: (1) ISO Class 5 laminar airflow; (2) precision temperature regulation (22.5 ± 0.5 °C); and (3) batch-validated sterile instrument management.

After the surgical site was disinfected, a Foley catheter was inserted for bladder emptying. This process began with cervical cold-knife circumcision after a ropivacaine-adrenaline solution was infiltrated to achieve the purposes of hydrodissection, vasoconstriction, and additional local anesthesia [12]. Additionally, anterior and posterior colpotomies were carried out with cold scissors [17]. The clamping and transection of uterosacral ligaments were completed using cold scissors [17]. The vNOTES port (Surgaid Medical, Xiamen, China) was then placed via anterior colpotomy from the bladder to the uterus, whereas posterior colpotomy was performed in pouch of Douglas [17]. A pneumoperitoneum was established through CO2 insufflation, maintaining the maximum intraperitoneal pressure at 10 mmHg [5], and later a 30-degree endoscope was inserted. The uterine dissection was conducted from caudal to cranial with standard endoscopic instruments (cold grasping forceps, bipolar grasping forceps, and a sealing device). For patients requiring salpingo-oophorectomy, bipolar grasping forceps were used to coagulate the infundibulopelvic ligament before subsequent dissection [14, 17]. To reduce the risk of epithelial ovarian cancer, prophylactic salpingectomy was routinely performed [17]. Thereafter, vaginal cuff was closed directly using the running Vicryl 1 suture, with uterosacral ligament attachment. Following the final disinfection, the vaginal plug was positioned.

The LH procedure was performed as described by Richards L et al. [5, 13, 24], with a pneumoperitoneum of 12 mmHg. After every surgical procedure, the delayed absorbable suture was used to close the fascia.

Ethics

Every subject offered informed consent for anonymous data collection in this study. Our study protocol gained approval from the Ethics Committee of Affiliated Nanchong Central Hospital of North Sichuan Medical College (No. 2022066) and conducted following the 1963 Helsinki Declaration.

Parameters

Our primary outcome was the time to first anal exhaust (with bowel sound to recover), indicating physical recovery [6]. The secondary outcome was the RTW time, which was related to recovery of social function and mental function in patients [25].

Baseline characteristics of patients included age, body mass index (BMI), the American Society of Anesthesiologists (ASA) score, parity, type of occupation, previous history of abdominal surgery, histological subtype, and the uterine volume. The ASA score was classified according to the standard criteria of ASA classification [26]. Operation time referred to the duration between the beginning and the end of the surgery [27]. Blood loss was calculated with a clean bottle during the surgery. Wound healing indicated the difference in healing at the trocar site between the two techniques [28]. Intraoperative complications involved transfusion in 72 h postoperatively, ureter or bladder injury or bowel injury [29]. The conversion rate indicated the switch of surgical approach from laparoscopy to laparotomy in patients undergoing LH, or from vNOTES to laparoscopy in patients undergoing vNOTEH. Postoperative complications were fever (> 38 °C) for > 23 h after surgery, short-term abnormalities in liver and kidney functions, urinary retention, severe lower extremity edema, postoperative infection, lymphocytic cyst infection, bowel obstruction, severe anemia, vault blood loss volume, vaginal vault dehiscence, urinary tract infection, fistula, lymphedema, pelvic infection, deep venous thrombosis, and remnant drain catheter [29]. Procedure-related variants included operation time, total blood loss, surgical complications requiring clinical intervention, time to first anal exhaust and RTW time, postoperative analgesia medicine use, postoperative hospitalization, postoperative time of first sexual intercourse, postoperative dyspareunia, and the cosmetic outcomes. To be specific, operation time, the time to first anal exhaust, postoperative analgesia medicine use, surgical complications requiring clinical intervention and postoperative hospitalization were assessed by the medical records after surgery during hospitalization. By adopting the numeric rating scale (NRS) (range: 0–10, 0 = no satisfactory, 10 = rather satisfactory), the postoperative cosmetic satisfaction (CS) was evaluated. In-hospital outcomes (e.g., operation time, the time to first anal exhaust, and postoperative analgesia use) were extracted from medical records. Early mobilization and diet advancement were both suggested for all patients. Follow-up outcomes (e.g., RTW time and CS) were collected via on-site or telephone questionnaire surveys (Fig. S1). RTW guidance was offered by the health care professional to answer related questions and draw up the RTW plan [30].

This work has been registered at https://www.chictr.org.cn with registration NO. ChiCTR2200063125 on Sep 27, 2022. The minimal postoperative follow-up period was 1 month.

Statistical analysis

SPSS software (SPSS 22, Armonk, NY, USA) was employed for statistical analysis. Continuous data were summarized as mean ± standard deviation or median (interquartile range, IQR) and compared by unpaired Two-Sample T-Test Allowing Unequal Variance, whereas categorical data were represented by counts and percentages and compared by chi-squared tests. Factors affecting the time to first anal exhaust were identified by linear regression, with covariates including age, BMI, ASA score, surgical approach, operation time, and total blood loss. Multivariate Cox proportional hazards regression was conducted for analyzing factors influencing RTW time, including age, BMI, ASA score, surgical approach, the time to first anal exhaust, surgical complications, and postoperative hospitalization. Kaplan-Meier (K-M) curves were plotted for comparing the time-to-event outcomes in the two groups. A p < 0.05 stood for significant differences.

Results

Patient characteristics

Totally 330 CIN II-III patients with or without uterine fibroids or adenomyosis were involved in this prospective cohort study. Of them, 92 cases (27.9%) received vNOTEH, while 238 (72.1%) received LH. Among those working patients (subgroup), 22 (23.9%) in the vNOTEH group and 76 (31.9%) in the LH group returned to work during the follow-up period. The baseline characteristics, including age, BMI, ASA score, parity, type of occupation, previous abdominal surgery, histological subtype, and uterine volume, were comparable in two groups and subgroups (all P > 0.05, Table 1 exhibits the basic features of the total cohort, Table 2 displays basic features in the subgroup who returned to work after surgery). No cases required conversion to an alternative surgical approach, and no readmission was observed in either group.

Table 1 Demographic and clinical characteristics of participants
Table 2 Demographic, clinical characteristics and surgical outcomes of patients who returned to work after surgery

Among patients who failed to resume employment by the conclusion of the follow-up period, those requiring extended sick leave or temporary work suspension predominantly belonged to the physically demanding occupational categories (the specific proportions are shown in Table 1). The median follow-up period was similar between the two groups (vNOTEH: 15 months vs. LH: 14 months; P = 0.235). Additionally, the proportion of patients with follow-up < 3 months did not differ significantly (vNOTEH: 46.4% vs. LH: 26.6%; P = 0.915; see Table 1 for details).

Surgical outcomes of the total cohort

The vNOTEH group demonstrated significantly shorter operation time (median: 90.0 min, IQR: 75.0–110.0 min), faster time to first anal exhaust (50.8 ± 13.0 h), and shorter postoperative hospitalization (median: 5 days, IQR: 5–6 days) than the LH group (all P < 0.05, Table 3 presents the surgical outcomes of the total cohort). Surgical complications requiring clinical intervention or postoperative dyspareunia were not significantly different between two groups (P> 0.05). Nevertheless, cosmetic satisfaction scores of vNOTEH group (median: 9 points, IQR: 8–9 points) remarkably increased compared with LH group (P < 0.05, Table 3 shows the surgical outcomes for the total cohort).

Table 3 Surgical outcomes of patients with benign uterine disease between vNOTES group and LH group

Factors affecting the time to first anal exhaust

The linear regression model was adopted for evaluating factors influencing the time to first anal exhaust, including age, BMI, ASA score, surgical approach (vNOTES vs. laparoscopy), operation time, and total blood loss. The vNOTES approach was significantly associated with the shorter time to first anal exhaust (Table 4 presents all factors affecting the time to first anal exhaust). K-M analysis further confirmed that the median time to first anal exhaust of vNOTEH group remarkably decreased relative to LH group (48.0 h vs. 69.0 h, P < 0.001, Fig. 2 presents the K–M curves).

Table 4 Coefficient of multivariable regression model of time to first anal exhaust
Fig. 2
figure 2

Recovery outcomes for patients underwent vNOTES hysterectomy.A, the estimated median time to first anal exhaust was shorter in vNOTEH group than that in laparoscopic hysterectomy group (50.8 hours vs. 70.2 hours, P<0.001); B, the median time to return to work was shorter in vNOTEH subgroup than that in LH subgroup (2.4 months vs. 4.0 months, P=0.011) (vNOTEH, Vaginal Natural Orifice Transluminal Endoscopic hysterectomy).

The RTW time

The vNOTEH cohort demonstrated superior recovery profiles to conventional LH, particularly with regard to the occupational rehabilitation. The employed patients receiving vNOTEH resumed work significantly earlier (median 2.0 vs. 3.0 months; IQR 1.0-3.3 vs. 2.0–6.0 months, P < 0.001, Table 5 displays the surgical outcomes in subgroups), and K-M analysis confirmed the accelerated return-to-work trajectories (median 2.0 vs. 3.0 months, P = 0.011; Fig. 2). By 4 months postoperatively, 81.8% of vNOTEH patients returned to employment, while the value was 68.4% in the LH group, and all vNOTEH patients reached complete workforce reintegration by 6 months after surgery, whereas the figure was 76.9% in the controls (Fig. 2 for K–M curves).

Table 5 Surgical outcomes of patients who returned to work after surgery

Moreover, the operative efficiency metrics significantly favored vNOTEH, with reduced operation time (median 85 vs. 110 min), shorter hospitalization (8.0 vs. 8.0 days), and enhanced cosmetic satisfaction (NRS 9.0 vs. 8.0, all P < 0.05). Notably, both approaches showed comparable safety profiles, with no between-group differences in intervention-requiring complications (4.6% vs. 1.0%, P > 0.05).

Factors affecting the RTW time

A multivariate Cox proportional hazards regression model was used for identifying factors affecting RTW time. The vNOTES approach (HR = 2.093, 95% CI: 1.186–3.693, P = 0.011) and shorter postoperative hospitalization (HR = 0.855, 95% CI: 0.738–0.977, P = 0.021) significantly related to earlier return to work (Table 6 displays all factors affecting the RTW time). These results demonstrated that the HR of the vNOTES approach was > 1, meaning the higher likelihood of returning to work sooner.

Table 6 Univariate and multivariate Cox proportional hazards analysis of time to return to work

Discussion

This prospective study revealed that vNOTEH was characterized by a short time to first anal exhaust and a short RTW time than those of LH. Additionally, vNOTEH resulted in the shorter operation time, reduced postoperative hospitalization, and superior cosmetic outcomes, without increasing surgical complications or postoperative dyspareunia. Importantly, the vNOTES approach was identified as an independent factor influencing the recovery outcomes.

Hysterectomy is a commonly performed surgery to manage benign uterine disorders [3]. Currently, conventional surgical approaches include vaginal hysterectomy, abdominal hysterectomy, and LH [13, 31,32,33]. According to the recommendation from the American College of Obstetricians and Gynecologists (ACOG) and the International Society for Gynecologic Endoscopy (ISGE) [34], vaginal hysterectomy is considered as the preferential route to remove the non-prolapsed uterus when hysterectomy is indicated and technically feasible, due to its benefit of faster returning to normal activities and fewer febrile postoperative episodes [35]. However, vaginal hysterectomy is often limited by factors including a large uterine size, a narrow vaginal access, nulliparity, or a history of cesarean Sects [35, 36]. In contrast, vNOTEH integrates the benefits of vaginal surgery with enhanced endoscopic visualization, expanding its applicability to patients with challenging anatomical conditions [37]. For instance, vNOTEH has been successfully performed in cases involving uteri > 280 g, achieving a success rate of 99% [17]. Due to the feasibility and safety, vNOTEH has been reported as a minimally invasive, painless, scarless and novel way with the benefit of a rapider return to daily life [38]. This minimally invasive, scarless approach not only facilitates the faster recovery, but also offers a valuable training opportunity for residents and young gynecologists, potentially shortening the learning curve for vNOTES.

The socioeconomic significance of postoperative recovery in hysterectomy patients is underscored by their pivotal societal and familial roles, where delayed recuperation may precipitate prolonged workforce absence, diminished quality of life, and substantial societal costs [9, 39, 40]. Our findings demonstrated the compelling advantages of vNOTE. To be specific, patients achieved the first bowel recovery in a median of 48.0 h versus 69.0 h with LH, coupled with a clinically meaningful reduction in the median RTW time (2.0 vs. 3.0 months). These outcomes align with the established benchmarks from Vonk Noordegraaf A et al. [40], who reported the median RTW intervals of 60 days (IQR 28–101) and 69 days (IQR 56–135) for intermediate and major gynecological surgeries, respectively. This comparative analysis not only validates the biological plausibility of our results, but also accentuates the dual clinical-societal value proposition of vNOTES. Specifically, the 21-h acceleration in bowel function recovery and the 30% reduction in workforce reintegration time collectively suggest that vNOTEH may alleviate both physiological stress and socioeconomic strain, particularly the cascading burdens on the familial care systems and productivity losses. The mechanistic consistency between the expedited gastrointestinal recovery (a well-established ERAS surrogate) and the earlier RTW further reinforces the translational relevance of our findings.

The mechanisms underlying the superior recovery outcomes associated with vNOTEH warrant further exploration. Firstly, consistent with the review by Matak L, et al. [41], the reduced operation time observed in vNOTEH, despite the technical challenges of the “chopsticks effect,” may contribute to faster recovery without increasing complications such as nerve or urinary tract injuries [42]. Second, vNOTEH aligns with the principles of ERAS [43], which have been demonstrated to improve surgical outcomes by minimizing physical and psychological stress. Third, the absence of abdominal incisions in vNOTEH eliminates the concerns of wound healing and enhances cosmetic satisfaction, which is particularly valued by younger patients [44]. Finally, the superior visualization provided by vNOTES makes it possible to perform safe and effective surgeries for patients with challenging anatomical features, such as obesity, prior abdominal surgery, and large uteri [17].

Limitations

Despite these promising findings, our study still has several limitations. First, the non-randomized design introduced the potential bias, as patients were assigned to vNOTES or laparoscopy group based on preference, surgeon expertise, and instrument availability. Although the baseline characteristics were adjusted in our analyses, unmeasured confounders might still persist. Second, we focused on patients with high-grade CIN (often with fibroids/adenomyosis) at a single institution, and the outcomes might differ in other benign hysterectomy populations or in different healthcare settings, which might limit the applicability of our results. Third, factors such as social support, and postoperative care protocols (e.g., ERAS implementation) were not assessed, potentially biasing the recovery time comparisons. Lastly, while faster recovery may reduce social burden, the study lacked cost-effectiveness analyses and comprehensive quality-of-life measures (beyond cosmetic satisfaction), leaving the broader societal impacts unverified. We are planning a multicentral study to include those factors to test our results.

Conclusion

In conclusion, for female patients, vNOTES might be advantageous in its earlier recovery of intestinal function and the earlier return to work after hysterectomy compared with laparoscopy.

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. With regard to the publication and utilization of datasets, all contributing authors to this article have executed consent declarations.

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Acknowledgements

Not applicable.

Funding

This work was supported by National Key R&D Plan for Intergovernmental Cooperation, the Ministry of Science and Technology of China (Grant No.2022YFE0133100), Foundation of State Key Laboratory of Ultrasound in Medicine and Engineering (Grant No. 2024KFKT016)and the Project of North Sichuan Medical College Youth Program (Grant No. CBY23-QNA19).

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This study was designed by YT, HQH, YXL and carried out by YT, JL, JRH and XC, CLF, JW, and XMC provided data from medical records. All drafted the first manuscript with help from HQH and YXL. All authors contributed to and approved the final version of the article for publication.

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Correspondence to Yue-xi Luo.

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The written informed consent was acquired from each participant to gather their data anonymously for research purpose. The approval of this study was obtained from Ethics Committee of the Affiliated Nanchong Central Hospital of North Sichuan Medical College (No. 2022066). All procedures performed in studies involving human participants were in accordance with the 1963 Helsinki Declaration.

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Tang, Y., Fang, Cl., Huang, Jr. et al. Comparison of rapid recovery outcomes between vNOTES hysterectomy and laparoscopic hysterectomy: a prospective study. BMC Surg 25, 189 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12893-025-02906-9

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