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

Bicetre Hospital

Status: Unknown

Conditions: Rate of Complete Resection in a Unique Surgical Time

Treatments: Device: 26Fr resector; Device: 18.5 resector

Study type: Interventional

Funder types: Other

Identifiers

NCT03402516

2016-A01740-51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 308 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No medical care

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

18.5Fr resector

Experimental group

Description:

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.

Treatment:

Device: 18.5 resector

26Fr resector

Active Comparator group

Description:

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.

Treatment:

Device: 26Fr resector