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RecruitingNCT07057115vNOTESUpdated Aug 5, 2025

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

An interventional study of vNOTES Salpingectomy Group. and Laparoscopic Salpingectomy in Ectopic Pregnancy, sponsored by Gaziosmanpasa Research and Education Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Gaziosmanpasa Research and Education Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Ectopic Pregnancy

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Keywords

  • vNOTES
  • laparoscopy
  • salpingectomy
03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's planned enrollment of 56 is below the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

Gaziosmanpasa Research and Education Hospital is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form to participate in the study

Exclusion criteria

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    vNOTES Salpingectomy Group

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

    Procedure: vNOTES Salpingectomy Group.

  • Active comparator
    Laparoscopic Salpingectomy Group

    Patients undergoing salpingectomy via conventional laparoscopic surgery.

    Procedure: Laparoscopic Salpingectomy

Interventions

  • ProcedurevNOTES Salpingectomy Group.

    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.

  • ProcedureLaparoscopic Salpingectomy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months postoperatively

  2. 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.

    Time frame: 6 hours postoperatively

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Jan 2026, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2025
First posted
Jul 9, 2025
StartActual
Jul 1, 2025
Primary completionEst.
Jan 1, 2026
CompletionEst.
Jun 1, 2026
Last update
Aug 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07057115
Responsible party
Sponsor
First posted
Jul 9, 2025
Start date
Jul 1, 2025
Primary completion
Jan 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Aug 5, 2025

Study contacts

yağmur aciyiyen, md
Contact
yagmuraciyiyen@gmail.com
+90 5425669593
ecenur çelikoğlu, md
Contact
ecenurcelikoglu14@gmail.com
+90 5385492848
havva betül bacak, md
principal investigator · Gaziosmanpaşa training and research hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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