Benefits of Laparoscopy by Single Port Access for Adnexal Surgery

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Adnexal Pathology

Treatments: Procedure: Adnexal surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02739724

2015-A01217-42

2015-32 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Classic laparoscopy

Active Comparator group

Description:

Patients will undergo laparoscopy surgery with classic laparoscopy technic.

Treatment:

Procedure: Adnexal surgery

Laparoscopy single port access

Experimental group

Description:

Patients will undergo laparoscopy surgery by single port access technic.

Treatment:

Procedure: Adnexal surgery