Clinical trial NCT04315779: Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy
Official title: Comparison of Conventional Laparoscopy and Natural Orifice Transluminal Endoscopic Surgery in the Surgical Treatment of Tubal Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ectopic Pregnancy
Keywords: natural orifice transluminal endoscopic surgery
laparoscopy
ectopic pregnancy
minimally invasive surgery
quality of life
sexual function
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Successful completion of surgery as intended
timeFrame: Intraoperative, from the beginning to the end of surgical intervention
measure: Operating time
timeFrame: Intraoperative
measure: Reoperation rate
timeFrame: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
measure: Complication rate
timeFrame: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Secondary outcomes:
measure: Quality of Recovery-40 questionnaire
timeFrame: Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery
measure: Quality of life change
timeFrame: Preoperative, Postoperative 1-month
measure: Postoperative pain scores
timeFrame: 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
measure: Sexual function
timeFrame: Postoperative 3 months
measure: The need for additional analgesic use
timeFrame: Postoperative period until discharge, expected to be up to 3 days following surgery
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University University Hospital, Department of Obstetrics and Gynecology
state: Izmir
Study officials:
References: