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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ectopic Pregnancy
• Intervention / Treatment: Procedure: Salpingectomy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gokay Ozceltik; Phone Number: +905330922020; Email: gokayozceltik@hotmail.com

Study Locations

• Turkey
  • Izmir
    • Bornova, Izmir, Turkey, 35100
      • Recruiting
      • Ege University University Hospital, Department of Obstetrics and Gynecology
      • Contact: Gokay Ozceltik; Phone Number: +905330922020; Email: gokayozceltik@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful completion of surgery as intended	The completion of the surgery with the route planned without having to change the surgical route	Intraoperative, from the beginning to the end of surgical intervention
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

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-40 questionnaire	The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points	Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery
Quality of life change	Short form 36 item health survery (SF-36) questionnaire will be self-administered by patients at different time points	Preoperative, Postoperative 1-month
Postoperative pain scores	Postoperative pain will be assessed on a 10-cm visual analog scale at different time points	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
Sexual function	Female sexual function index (FSFI) questionnaire will be self-administered by patients at postoperative 3-months	Postoperative 3 months
The need for additional analgesic use	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.	Postoperative period until discharge, expected to be up to 3 days following surgery

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Anticipated): February 19, 2021
• Study Completion (Anticipated): May 19, 2021

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; laparoscopy; sexual function; minimally invasive surgery; natural orifice transluminal endoscopic surgery; ectopic pregnancy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Pregnancy, Ectopic; Cardiac Complexes, Premature; Pregnancy, Tubal
• Other Study ID Numbers: 20-2.1T/40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No