Comparison of Two Bipolar Resector in Less Than 3cm Myoma Resection (DIAPER)

Impact of the Diameter on the Performance of Two Bipolar Resectors 18.5Fr and 26Fr

Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used for myoma resection is 26Fr hysteroscope. Actual miniaturization of resector led to 18.5Fr resector with a potential benefit because of less dilatation. These resectors are often used but no scientific evaluation has been performed.

Hypothesis of this non inferiority trial is that complete resection in a unique surgical time will be comparable with both resectors.

Study Overview

• Status: Unknown
• Conditions: Rate of Complete Resection in a Unique Surgical Time
• Intervention / Treatment: Device: 18.5 resector; Device: 26Fr resector

Detailed Description

Myoma type 0, 1 or 2 are often symptomatic (abnormal uterine bleeding or infertility) and hysteroscopic resections are thus frequent. This management is a minimally invasive surgery.

Usually, a 26Fr resectoscope is used and the main articles on this topic report hysteroscopie resections with a 26Fr resectoscope. Miniaturization of resector led to decrease in the size of resectors with a potential benefit because of a less important cervical dilatation and then a smaller risk of adverse events and an increase in the number of surgery under local anaesthesia.

Use of 18.5Fr resectors is more and more frequent but, to our knowledge, it has never been evaluated for benefit on cervical dilatation but also for rate of complete resection in one time, surgical length and rate of unbalanced input/output.

Intuitively, a smaller diameter could led to a less traumatic cervical dilatation but it could also led to an higher risk of incomplete treatment in one time and a longer surgical duration and a more frequent unbalanced input/output.

No study compare use of these two resectors (18.5 and 26Fr) all the more randomized. With 26Fr resector, the rate of complete resection in one time for less than 3cm myoma is around 90%. If this rate is higher with the 18.5Fr resector, the risk/benefit balance (including economic evaluation) won't be favorable to this use.

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94275
    • Recruiting
    • Hôpital Bicêtre
    • Contact: Perrine Capmas, MD-PhD; Phone Number: +33145217714; Email: perrine.capmas@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Older than 18 years old
• With a type 0,1 or 2 unique myoma requiring surgery

Exclusion Criteria:

• No medical care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 18.5Fr resector; Used of a 18.5Fr bipolar resector for hysteroscopic myomectomy. Cervical dilatation would be performed until Hegar bougie number 7 and then a classic hysteroscopic resection will be performed with a 18.5Fr bipolar resector.	Device: 18.5 resector; hysteroscopic myomectomy with a 18.5 Fr resector after cervical dilatation until Hegar bougie number 7
ACTIVE_COMPARATOR: 26Fr resector; Used of a 26Fr bipolar resector for hysteroscopic myomectomy. Cervical dilatation would be performed until Hegar bougie number 10 and then a classic hysteroscopic resection will be performed with a 24Fr bipolar resector.	Device: 26Fr resector; hysteroscopic myomectomy with a 26Fr resector after cervical dilatation until Hegar bougie number 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison with chi square test of rate of complete surgery in one time	Complete resection of myoma in one time	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	Comparison of duration of surgery between 2 arms	3 years
Rate of unbalanced in and out balance	Comparison of rate of unbalanced in and out balance between the 2 groups. A in/out balance higher than 500cc will be consider has unbalanced).	3 years
Cost effectiveness analyses	Comparison of cost for complete resection of myoma between groups	3 years
Complications rate	Comparison of complications rate (including cervical complications)	3 years
Use of a 26Fr resector	Report of the rate of use of a 26Fr resector in the 18.5Fr group	3 years

Collaborators and Investigators

• Sponsor: Bicetre Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): March 31, 2022

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (ACTUAL): January 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: hysteroscopic myomectomy; 26Fr resector; 18.5Fr resector
• Other Study ID Numbers: 2016-A01740-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No