Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy

Not Applicable

• Conditions: Ectopic Pregnancy

• 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

Study Timeline

• Study Start: 2020-02-19
• Status Verified: 2020-03
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-18
• Last Update Submitted: 2020-03-18
• Study First Posted: 2020-03-20
• Last Update Posted: 2020-03-20
• Primary Completion: 2021-02-19
• Study Completion: 2021-05-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Adults over 18 years of age,
• Diagnosis of tubal ectopic pregnancy
• Patient's preference to undergo salpingectomy

Exclusion Criteria

• Patients with contraindication to endoscopic surgery
• Refusal to sign informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
Operating time	Intraoperative

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