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NCT Number: NCT07057115

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

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.

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Key information

Conditions

Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

havva betül bacak, md

CONTACT

[email protected]

5333610088

About this study

This study aims to compare the clinical outcomes of two surgical approaches-vaginal natural orifice transluminal endoscopic surgery (vNOTES) salpingectomy and conventional laparoscopic salpingectomy-in patients diagnosed with ectopic pregnancy. The primary objective is to evaluate and contrast parameters such as operative time, postoperative pain, complication rates, hospital stay duration, and recovery times between the two groups. The goal is to assess the feasibility, safety, and effectiveness of the vNOTES technique as an alternative minimally invasive method for the management of ectopic pregnancy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 6 months postoperatively

    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.

  2. Postoperative Pain Score (VAS) at 6 Hours After Surgery

    Time frame: 6 hours postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ecenur çelikoğlu, md

CONTACT

[email protected]

+90 5385492848

yağmur aciyiyen, md

CONTACT

[email protected]

+90 5425669593

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

Comparison of vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Salpingectomy and Laparoscopic Salpingectomy Performed for Ectopic Pregnancy

Acronym: vNOTES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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