Benefits of Laparoscopy by Single Port Access for Adnexal Surgery

Not Applicable

• Conditions: Adnexal Pathology
• Interventions: Procedure: Adnexal surgery

• Registration Number: NCT02739724
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Introduction

Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies. Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So it seems interesting to conduct a new study about this technic. Aim of this study is to compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or classic laparoscopy (CL).

Materiel and Methods

We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring laparoscopic surgery for adnexal pathology with stratification for procedure (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is postoperative pain evaluation at 24 hours. Secondary objectives are characteristics and perioperative complications, duration of procedure, postoperative quality of life and immediate postoperative pain.

We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic scale 0-10). The estimated size of population number is 54 per group and 108 for the study.

Expected results

We expected a significant decrease of postoperative pain with SPA technic. This data will be interesting to promote use of SPA technic for adnexal surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-12
• Last Update Submitted: 2016-04-12
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Primary Completion: 2018-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

Presumed benign adnexal disease Adnexal pathologies treated between 7:00 AM and 10:00 PM Signed informed consent Patient presenting no contraindication to laparoscopy

Exclusion Criteria

Salpingitis and twist annexes. The patient does not fluently read French.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic laparoscopy	Adnexal surgery	Patients will undergo laparoscopy surgery with classic laparoscopy technic.
Laparoscopy single port access	Adnexal surgery	Patients will undergo laparoscopy surgery by single port access technic.

Primary Outcome Measures

Name	Time	Method
Postoperative pain measured with visual analog scale	Postoperative pain evaluation at 24 hours

Secondary Outcome Measures

Name	Time	Method
Postoperative pain measured with visual analog scale	2 hours, 4 hours, 6 hours, 1 month
timing in minutes between incision and suture	4 hours
Blood lost in milliliters (mls)	1 hour
Inpatient numbers of days	1 month
Non steroid anti inflammatory numbers of pills taken	1 month
number of convertion to laparotomy, Postoperative hernia	1 month
visual analog scale for cosmetic satisfaction	1 year

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France