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

August 6, 2020 updated by: Andre Nazac, Brugmann University Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Uterine fibroids are detected in many cases of excessive bleeding or consultation for primary or secondary infertility. When they are of the submucosal type, they require a surgical treatment by hysteroscopy. The hysteroscopic resection of submucosal fibroids described by Neuwirth and Amin in 1976 allowed to reduce the morbidity, the length of hospital stay and the cost of the therapeutic treatment, with a satisfactory rate of functional successes.

The surgical hysteroscopic treatment of symptomatic submucosal myoma was performed initially by a monopolar endoscopic resection. This required a resection using glycine as a distension medium, essential for the conduction of monopolar current.

Complications proper to the monopolar resection have been described and are now well known. The first specific complication is the TURP syndrome, linked to the reabsorption of the glycine byproducts of the distensium medium. It can cause hyponatremia and lead to a cerebral edema. This complication can be prevented by limiting the duration of the intervention to 45 minutes and constantly monitoring the input-output balance.

The second specific complication is related to the diffusion of heat that can damage to surrounding healthy tissue and increase the risk of uterine adhesions. These adhesions are the source of menstrual disorders like hypomenorrhea or amenorrhea, infertility or a recurrent miscarriages.

For over 20 years, several approaches have been proposed to reduce the occurrence of postoperative adhesions. However, their results are either not convincing, either in need of confirmation.

Since several years, the use of the bipolar energy for hysteroscopic resection has been developped.The advantage of this technique is to avoid glycine as distension medium and use saline instead, hereby significantly reducing the risk of hyponatremia. It especially gives a smaller heat diffusion, hereby limiting the damage to the healthy tissues nearby.

Although hysteroscopic bipolar resection of submucosal fibroids is now a routine technique, there are to this date no studies in the literature comparing the use of monopolar and bipolar energy in the hysteroscopic myomectomy.

The main objective of this study is to compare the rate of adhesions after resection of uterine myomas, with the use of bipolar versus monopolar current. The secondary objective is to evaluate the impact on subsequent fertility through the number of pregnancies and miscarriages.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann
  • France
      • Le Kremlin Bicêtre, France, 94270
        • CHU Bicêtre, Kremlin Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Symptomatic (menorrhagia or primary/secondary infertility) with pregnancy wishes
  • One submucosal myoma, type 0 to Type II, accessible to a hysteroscopic surgery

Exclusion Criteria:

  • Several submucosal myomas
  • Pregnant woman
  • Patient under anticoagulating treatment (anti-vitamin K-type)
  • Patient with a malignant endometrial pathology
  • Patient having one or more endo-uterine synechiae
  • Myoma larger than 5 cm
  • Uterine malformation
  • Active infection, not healed
  • Refusal to participate in the Protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bipolar energy
Hysteroscopic resection of symptomatic sub mucosal myomas with the use of bipolar energy
Procedure: Hysteroscopic resection with bipolar energy
Hysteroscopic resection with bipolar energy
Active Comparator: Monopolar energy
Hysteroscopic resection of symptomatic sub mucosal myomas with the use of monopolar energy
Procedure: Hysteroscopic resection with monopolar energy
Hysteroscopic resection with monopolar energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uterine adhesions rate
Time Frame: 6 weeks after surgery
The main goal of this study is to compare the rate of uterine adhesions six weeks after the hysteroscopic surgical treatment of sub mucosal uterine myomas, in a group where bipolar energy is used versus a group where monopolar energy is used during the surgery. Outcome measured at the diagnostic hysteroscopic visit, 6 weeks after surgery.
6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 18 months after surgery
Number of evolutive pregnancies - phone contact 18 months after surgery
18 months after surgery
Spontaneous abortion rate
Time Frame: 18 months after surgery
Number of spontaneous abortions - phone contact 18 months after surgery
18 months after surgery
Surgery duration
Time Frame: From the entry to the exit of the hysteroscope from the body. Ambulatory surgery, max 1 day
Duration of the surgical intervention
From the entry to the exit of the hysteroscope from the body. Ambulatory surgery, max 1 day
Per-surgery complications rate
Time Frame: From the entry to the exit of the hysteroscope from the body. Ambulatory surgery, max 1 day
Complications rate during the surgery duration
From the entry to the exit of the hysteroscope from the body. Ambulatory surgery, max 1 day
Post-surgery complications rate
Time Frame: 6 weeks after surgery
Post-surgery complications rate, measured at the diagnostic hysteroscopic visit performed 6 weeks after surgery.
6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brugmann University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2017

Primary Completion (Actual)

December 3, 2019

Study Completion (Actual)

December 3, 2019

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-Monobisy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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