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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorGaziosmanpasa Research and Education Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • vNOTES Salpingectomy Group.

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: vNOTES Salpingectomy GroupExperimental treatment 1 intervention
Group B: Laparoscopic Salpingectomy GroupActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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