Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy
- Conditions
- Ectopic Pregnancy
- Interventions
- Procedure: Salpingectomy
- Registration Number
- NCT04315779
- Lead Sponsor
- Ege University
- Brief Summary
In this study we aim to compare conventional laparoscopy and natural orifice transluminal endoscopic surgery in the surgical treatment of ectopic pregnancy.
All the patients, with an indication of surgery for ectopic pregnancy, will be asked to participate in this clinical trial.
Indication of surgery will be based on clinical findings, ultrasound scans and serum hcg levels. There will be no exclusion criteria.
Duration of surgery, successful completion of the operation, intraoperative data and postoperative data will be collected.
All the patients will be asked to fill out quality of recovery-40 (QoR-40) questionnaire and 36-item short form health survey (SF-36) before surgery.
QoR-40 questionnaire will be repeated 24 hours after surgery and repeated every 24 hours until discharge. SF-36 will be repeated at 1-month follow-up visit. Patients will be also evaluated at postoperative 3-months, and female sexual function index will be asked to be filled-out.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
- Adults over 18 years of age,
- Diagnosis of tubal ectopic pregnancy
- Patient's preference to undergo salpingectomy
- Patients with contraindication to endoscopic surgery
- Refusal to sign informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transvaginal natural orifice transluminal endoscopic surgery Salpingectomy In this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery Conventional laparoscopy Salpingectomy In this arm, patients will be treated via conventional laparoscopy
- Primary Outcome Measures
Name Time Method Reoperation rate During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month Complication rate During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month Operating time Intraoperative Successful completion of surgery as intended Intraoperative, from the beginning to the end of surgical intervention The completion of the surgery with the route planned without having to change the surgical route
- Secondary Outcome Measures
Name Time Method Quality of life change Preoperative, Postoperative 1-month Short form 36 item health survery (SF-36) questionnaire will be self-administered by patients at different time points
Postoperative pain scores Postoperative 2 hours, 6 hours, 12 hours, 24 hours, and every 24 hours until discharge (if the patient stays longer than 1 day at the hospital), , expected to be up to 3 days following surgery Postoperative pain will be assessed on a 10-cm visual analog scale at different time points
Sexual function Postoperative 3 months Female sexual function index (FSFI) questionnaire will be self-administered by patients at postoperative 3-months
The need for additional analgesic use Postoperative period until discharge, expected to be up to 3 days following surgery Patients will be routinely administered pethidine hydrochloride 3x50 mg parenteral on the day of surgery. Starting from postoperative day 1 patients will be administered paracetamol 500 mg oral upon their request. In case of inadequate pain relief and the need for additional analgesic use will ve recorded.
Quality of Recovery-40 questionnaire Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points
Trial Locations
- Locations (1)
Ege University University Hospital, Department of Obstetrics and Gynecology
🇹🇷Bornova, Izmir, Turkey