Vaginal natural orifice transluminal endoscopic surgery vs. single port assess for hysterectomy

Not Applicable

Completed

• Conditions: Diseases of the genitourinary system

• Registration Number: KCT0004605
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Introduction: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy has shown benefit in postoperative pain and operation time compared to laparoscopic hysterectomy in recent studies. However, no prospective studies comparing laparoendoscopic single-site (LESS) and vNOTES hysterectomy have been performed. This study aims to evaluate postoperative pain and safety of vNOTES hysterectomy compared to LESS hysterectomy for benign uterine disease. Methods: This study is a prospective, investigator-initiated randomized controlled pilot trial. A total of 26 patients were randomized and allocated to vNOTES group (n = 13) and LESS group (n = 13). The primary outcome was postoperative abdominal and vaginal pain evaluated 24 h after surgery. Secondary outcomes included the number of additional analgesics administered and the maintenance rate of patient-controlled analgesia (PCA). Results: No differences were shown in baseline characteristics between the two groups. Operation time was longer in the LESS group (median, 55 vs. 75 min; P = 0.027), and there were no differences in estimated blood loss, postoperative hemoglobin level, surgical indications, and hospitalization days. Postoperative abdominal pain intensity did not differ between the two groups, while the vNOTES group showed higher postoperative vaginal pain than the LESS group at 16 and 24 h after surgery (median, 3 vs. 1 and 2 vs. 0, P = 0.007 and P = 0.010, at 16 and 24 h respectively). No differences were shown in the number of additional analgesics and PCA use between the two groups. Conclusions: vNOTES hysterectomy can be safely performed for benign uterine disease requiring hysterectomy. However, vNOTES hysterectomy might be associated with higher postoperative vaginal pain intensity compared to LESS hysterectomy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-12-01
• Study Completion: 2021-12-31
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

1) Informed consent
2) Age: 19-80 years old
3) Diseases require hysterectomy (benign uterine mass, abnormal uterine bleeding, etc.)
4) Eligible for endoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
5) Understanding the contents of the study, proper compliance, ability to participate to the end of the trial

Exclusion Criteria

1) Pregnancy or breastfeeding
2) Virgin
3) Suspicion for pelvic malignancy
4) Previous cesarean section for three times or more
5) Suspicion for posterior cul-de-sac obliteration by vaginal examination
6) Inappropriate patients by the researcher's decision

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain

Secondary Outcome Measures

Name	Time	Method
ength of hospitalization;Estimated blood loss (intraoperiatve, postoperative);Postoperative hemoglobin drop;Duration of surgery;pelvic fluid collection;Postoperative complication;Reoperation within 6 months after surgery;Postoperative pain