Clinical trial NCT03402516: Comparison of Two Bipolar Resector in Less Than 3cm Myoma Resection
Official title: Impact of the Diameter on the Performance of Two Bipolar Resectors 18.5Fr and 26Fr
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rate of Complete Resection in a Unique Surgical Time
Keywords: hysteroscopic myomectomy
26Fr resector
18.5Fr resector
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 308
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison with chi square test of rate of complete surgery in one time
timeFrame: 3 years
Secondary outcomes:
measure: Duration of surgery
timeFrame: 3 years
measure: Rate of unbalanced in and out balance
timeFrame: 3 years
measure: Cost effectiveness analyses
timeFrame: 3 years
measure: Complications rate
timeFrame: 3 years
measure: Use of a 26Fr resector
timeFrame: 3 years
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicetre
Study officials:
References: