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

Ectopic Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04315779
• Other study ID #: 20-2.1T/40
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2020
• Est. completion date: May 19, 2021

Study information

• Verified date: March 2020
• Source: Ege University
• Contact: Gokay Ozceltik
• Phone: +905330922020
• Email: gokayozceltik[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 19, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Procedure:
• Salpingectomy
Patients will undergo removal of the affected tube

Locations

Country	Name	City	State
Turkey	Ege University University Hospital, Department of Obstetrics and Gynecology	Bornova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Operating time		Intraoperative
Primary	Reoperation rate		During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Primary	Complication rate		During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	Sexual function	Female sexual function index (FSFI) questionnaire will be self-administered by patients at postoperative 3-months	Postoperative 3 months
Secondary	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