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

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ClinicalTrials.gov Identifier: NCT02661087
Recruitment Status : Withdrawn (Principal investigator departure)
First Posted : January 22, 2016
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Andre Nazac, Brugmann University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Symptomatic Submucosal Myoma Procedure: Hysteroscopic resection with bipolar energy Procedure: Hysteroscopic resection with monopolar energy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : December 3, 2019
Actual Study Completion Date : December 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 18 months after surgery ]
    Number of evolutive pregnancies - phone contact 18 months after surgery

  2. Spontaneous abortion rate [ Time Frame: 18 months after surgery ]
    Number of spontaneous abortions - phone contact 18 months after surgery

  3. 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

  4. 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

  5. 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.



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661087


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
France
CHU Bicêtre, Kremlin Bicêtre
Le Kremlin Bicêtre, France, 94270
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: André Nazac, MD CHU Brugmann
Publications:

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Responsible Party: Andre Nazac, Head of Clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02661087    
Other Study ID Numbers: CHUB-Monobisy
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andre Nazac, Brugmann University Hospital:
submucosal myoma
hysteroscopic resection
bipolar energy
monopolar energy
Additional relevant MeSH terms:
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Myoma
Infertility
Gynatresia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms