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Benefits of Laparoscopy by Single Port Access for Adnexal Surgery

NCT02739724 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2016-04-15

No results posted yet for this study

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.

Conditions

  • Adnexal Pathology

Interventions

PROCEDURE

Adnexal surgery

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Urielle DESALBRES · AP-HM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-04-30
Completion
2019-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02739724 on ClinicalTrials.gov