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

NCT ID: NCT03402516

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2022-03-31

Brief Summary

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.

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.

Conditions

Rate of Complete Resection in a Unique Surgical Time

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

18.5 resector

Intervention Type: DEVICE

hysteroscopic myomectomy with a 18.5 Fr resector after cervical dilatation until Hegar bougie number 7

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.

Group Type: ACTIVE_COMPARATOR

26Fr resector

Intervention Type: DEVICE

hysteroscopic myomectomy with a 26Fr resector after cervical dilatation until Hegar bougie number 10

Interventions

18.5 resector

hysteroscopic myomectomy with a 18.5 Fr resector after cervical dilatation until Hegar bougie number 7

Intervention Type: DEVICE

26Fr resector

hysteroscopic myomectomy with a 26Fr resector after cervical dilatation until Hegar bougie number 10

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No medical care

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bicetre Hospital

OTHER

Sponsor Role: lead

Responsible Party

Capmas Perrine

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hopital Bicetre

Le Kremlin-Bicêtre, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Perrine Capmas, MD-PhD

Role: primary

perrine.capmas@aphp.fr

+33145217714

Other Identifiers

2016-A01740-51

Identifier Type: -

Identifier Source: org_study_id