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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients will undergo removal of the affected tube
Ege University University Hospital, Department of Obstetrics and Gynecology
Bornova, İzmir, Turkey (Türkiye)
RECRUITINGSuccessful completion of surgery as intended
The completion of the surgery with the route planned without having to change the surgical route
Time frame: Intraoperative, from the beginning to the end of surgical intervention
Operating time
Time frame: Intraoperative
Reoperation rate
Time frame: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Complication rate
Time frame: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Quality of Recovery-40 questionnaire
The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points
Time frame: 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
Time frame: Preoperative, Postoperative 1-month
Postoperative pain scores
Postoperative pain will be assessed on a 10-cm visual analog scale at different time points
Time frame: 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
Time frame: 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.
Time frame: Postoperative period until discharge, expected to be up to 3 days following surgery
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