Benefits of Laparoscopy by Single Port Access for Adnexal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Adnexal Pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Classic laparoscopy

Patients will undergo laparoscopy surgery with classic laparoscopy technic.

Group Type ACTIVE_COMPARATOR

Adnexal surgery

Intervention Type PROCEDURE

Laparoscopy single port access

Patients will undergo laparoscopy surgery by single port access technic.

Group Type EXPERIMENTAL

Adnexal surgery

Intervention Type PROCEDURE

Interventions

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Adnexal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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