Comparison of vNOTES and Laparoscopic Salpingectomy in the Surgical Treatment of Ectopic Pregnancy

NCT07057115 | Recruiting

• 1 other identifier: gopvnotesectopic
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares vNOTES salpingectomy and laparoscopic salpingectomy in the treatment of ectopic pregnancy, focusing on outcomes such as operative time, postoperative pain, and recovery.

Conditions

Ectopic Pregnancy

Keywords

vNOTES; laparoscopy; salpingectomy

Outcome Measures

Primary Outcomes (2)

• Change in Sexual Function Measured by PISQ-12 at 6 Months

  Sexual function will be evaluated using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), a validated instrument for assessing sexual function in women with pelvic floor disorders. Scores range from 0 to 48, with higher scores indicating better sexual function. The change in PISQ-12 scores from baseline to 6 months postoperatively will be compared between the vNOTES and laparoscopic groups.

  6 months postoperatively

• Postoperative Pain Score (VAS) at 6 Hours After Surgery

  Postoperative pain will be assessed using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The pain score at the 6th postoperative hour will be compared between the vNOTES and laparoscopic groups.

  6 hours postoperatively

Study Arms (2)

vNOTES Salpingectomy Group

EXPERIMENTAL

Patients undergoing salpingectomy via vaginal natural orifice transluminal endoscopic surgery (vNOTES).

Procedure: vNOTES Salpingectomy Group.

Laparoscopic Salpingectomy Group

ACTIVE COMPARATOR

Patients undergoing salpingectomy via conventional laparoscopic surgery.

Procedure: Laparoscopic Salpingectomy

Interventions

vNOTES Salpingectomy Group. PROCEDURE

Participants will undergo salpingectomy using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique. This minimally invasive procedure is performed transvaginally without abdominal incisions, offering potential benefits such as less postoperative pain, faster recovery, and better cosmetic outcomes.

vNOTES Salpingectomy Group

Laparoscopic Salpingectomy PROCEDURE

Participants will undergo conventional laparoscopic salpingectomy, a minimally invasive surgical technique performed through small abdominal incisions using a laparoscope. This method is the current standard approach for managing ectopic pregnancies.

Laparoscopic Salpingectomy Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with ectopic pregnancy Without heterotopic pregnancy Women aged 18-55 years, within reproductive age Patients for whom medical treatment is not appropriate Patients requiring surgical intervention Patients without systemic diseases that may contraindicate surgery Patients who have signed and approved the informed consent form to participate in the study

You may not qualify if:

• Ectopic pregnancy cases that can be treated with medical therapy Patients with advanced pelvic infections or pelvic anatomical abnormalities Patients with immunodeficiency or systemic diseases that contraindicate surgery

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• havva betül bacak, md

  Gaziosmanpaşa training and research hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yağmur aciyiyen, md

CONTACT

+90 5425669593; yagmuraciyiyen@gmail.com

ecenur çelikoğlu, md

CONTACT

+90 5385492848; ecenurcelikoglu14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, parallel assignment study in which participants diagnosed with ectopic pregnancy are allocated to undergo either vNOTES salpingectomy or conventional laparoscopic salpingectomy. Randomization is performed using the envelope method. Each participant receives only one type of surgical intervention, and outcomes are compared between the two groups.

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 9, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)