MedTrace Logo

Comparing Intra Uterine Synechiae Occurence Using Bipolar Energy Compared With Monopolar Energy in Myoma Resection on Women Having Menorraghia and/or Infertility

NCT02661087 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-08-07

No results posted yet for this study

Summary

Since the development in the last few years of the bipolar energy in the surgery by hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed by use of either monopolar or bipolar current.

It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the adhesion rate and fertility after the use of bipolar energy during the surgery are poor, and there is currently no recommendation as to the choice of technique to use. The main purpose of this study is to compare the rate of uterine adhesions six weeks after the surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.

Conditions

  • Symptomatic Submucosal Myoma

Interventions

PROCEDURE

Hysteroscopic resection with bipolar energy

Hysteroscopic resection with bipolar energy

PROCEDURE

Hysteroscopic resection with monopolar energy

Hysteroscopic resection with monopolar energy

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • André Nazac, MD · CHU Brugmann

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2019-12-03
Completion
2019-12-03

Countries

  • Belgium
  • France

Study Locations

More Related Trials

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 NCT02661087 on ClinicalTrials.gov