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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ectopic Pregnancy

Intervention / Treatment
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* Procedure: Salpingectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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natural orifice transluminal endoscopic surgery, laparoscopy, ectopic pregnancy, minimally invasive surgery, quality of life, sexual function