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

Sponsor

Ege University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04315779

Collaborator

(none)

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ectopic Pregnancy	Procedure: Salpingectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Conventional Laparoscopy and Natural Orifice Transluminal Endoscopic Surgery in the Surgical Treatment of Tubal Ectopic Pregnancy

Actual Study Start Date :

Feb 19, 2020

Anticipated Primary Completion Date :

Feb 19, 2021

Anticipated Study Completion Date :

May 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional laparoscopy In this arm, patients will be treated via conventional laparoscopy	Procedure: Salpingectomy Patients will undergo removal of the affected tube
Active Comparator: Transvaginal natural orifice transluminal endoscopic surgery In this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery	Procedure: Salpingectomy Patients will undergo removal of the affected tube

Arm

Intervention/Treatment

Active Comparator: Conventional laparoscopy

In this arm, patients will be treated via conventional laparoscopy

Procedure: Salpingectomy

Patients will undergo removal of the affected tube

Active Comparator: Transvaginal natural orifice transluminal endoscopic surgery

In this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery

Procedure: Salpingectomy

Patients will undergo removal of the affected tube

Outcome Measures

Primary Outcome Measures

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]
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]

Secondary Outcome Measures

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
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.