Comparison of the Efficiency of Bipolar Energy Versus Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia

NCT02642926 | Completed

• 1 other identifier: CHUB-Monobimen
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Since the development a few years ago of bipolar energy in the surgery by operative hysteroscopy, the hysteroscopic treatment of menorrhagia by endometrial ablation can be achieved either by the use of monopolar or bipolar current, in parallel with other techniques labelled as 'second generation' (microwave, radio frequency, thermal destruction ...) treating the uterine cavity. It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the success rate after bipolar endometrial ablation are poor and there is currently no recommendation as to the choice of technique to use. No prospective assessment exists to date in the literature to compare the difference in efficacy on bleedings when using monopolar or bipolar current. The goal of this study is to compare these two energies, by measuring the amount of bleeding calculated by the Higham score 12 months after the intervention.

Conditions

Menorrhagia

Keywords

menorrhagia; higham PBAC score; endometrial ablation; bipolar energy; monopolar energy

Outcome Measures

Primary Outcomes (1)

• Bleeding abundance

  Bleeding abundance will be measured by the Higham score, on a questionnaire sent to the patient.

  12 months after surgical intervention

Secondary Outcomes (5)

• Bleeding abundance

  6 months after surgical intervention

• Surgery duration

  From the entry till the removal of the hysteroscope from the body -ambulatory surgery (max one day)

• Per-operative complications rate

  From the entry till the removal of the hysteroscope from the body - ambulatory surgery (max one day)

• Post-operative complications rate

  6 weeks after the surgical intervention

• Re-do surgery rate

  12 months after the surgical intervention

Study Arms (2)

Monopolar endoscopic endometrial ablation

ACTIVE COMPARATOR

Procedure: Monopolar current

Bipolar endoscopic endometrial ablation

EXPERIMENTAL

Procedure: Bipolar current

Interventions

Monopolar current PROCEDURE

Hysteroscopic surgical treatment of menorrhagia by use of monopolar current

Monopolar endoscopic endometrial ablation

Bipolar current PROCEDURE

Hysteroscopic surgical treatment of menorrhagia by use of bipolar current

Bipolar endoscopic endometrial ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from menorrhagia
• Higham score \> 150
• No further pregnancy wish
• Failure of a former medical treatment
• Patients consulting a surgeon, for a standard of care surgical intervention

You may not qualify if:

• Pregnant women
• Menopausal women
• Patient under anticoagulant treatment, type anti-vitamin K (AVK)
• Patient with a malign endometrial pathology
• Patient with one or several known endo-uterine synechia
• Uterine malformation
• Active and uncured infection

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Bicêtre, Kremlin Bicêtre (A.P.H.P)

Bicêtre, 94270, France

Location

Related Publications (7)

• Duckitt K. Menorrhagia. BMJ Clin Evid. 2015 Sep 18;2015:0805.

  PMID: 26382038 BACKGROUND

• Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x.

  PMID: 2400752 BACKGROUND

• Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013 Nov 29;(11):CD000329. doi: 10.1002/14651858.CD000329.pub2.

  PMID: 24288154 BACKGROUND

• Boe Engelsen I, Woie K, Hordnes K. Transcervical endometrial resection: long-term results of 390 procedures. Acta Obstet Gynecol Scand. 2006;85(1):82-7. doi: 10.1080/00016340500424314.

  PMID: 16521686 BACKGROUND

• Brumsted JR, Blackman JA, Badger GJ, Riddick DH. Hysteroscopy versus hysterectomy for the treatment of abnormal uterine bleeding: a comparison of cost. Fertil Steril. 1996 Feb;65(2):310-6. doi: 10.1016/s0015-0282(16)58091-1.

  PMID: 8566254 BACKGROUND

• Mayor S. NICE says hysterectomy must be last option for heavy menstrual bleeding. BMJ. 2007 Jan 27;334(7586):175. doi: 10.1136/bmj.39105.376412.DB. No abstract available.

  PMID: 17255588 BACKGROUND

• Berg A, Sandvik L, Langebrekke A, Istre O. A randomized trial comparing monopolar electrodes using glycine 1.5% with two different types of bipolar electrodes (TCRis, Versapoint) using saline, in hysteroscopic surgery. Fertil Steril. 2009 Apr;91(4):1273-8. doi: 10.1016/j.fertnstert.2008.01.083. Epub 2008 Apr 18.

  PMID: 18371962 BACKGROUND

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• André Nazac, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

FR (1)