Comparison of vNOTES and Laparoscopic Salpingectomy in the Surgical Treatment of Ectopic Pregnancy
- Conditions
- Ectopic Pregnancy
- Registration Number
- NCT07057115
- Lead Sponsor
- Gaziosmanpasa Research and Education Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 56
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Sexual Function Measured by PISQ-12 at 6 Months 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.
Postoperative Pain Score (VAS) at 6 Hours After Surgery 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.
- Secondary Outcome Measures
Name Time Method