DIAPER: Comparison of Two Bipolar Resector in Less Than 3cm Myoma Resection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Comparison with chi square test of rate of complete surgery in one time [3 years]
Complete resection of myoma in one time
Secondary Outcome Measures
- Duration of surgery [3 years]
Comparison of duration of surgery between 2 arms
- Rate of unbalanced in and out balance [3 years]
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).
- Cost effectiveness analyses [3 years]
Comparison of cost for complete resection of myoma between groups
- Complications rate [3 years]
Comparison of complications rate (including cervical complications)
- Use of a 26Fr resector [3 years]
Report of the rate of use of a 26Fr resector in the 18.5Fr group
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Older than 18 years old
-
With a type 0,1 or 2 unique myoma requiring surgery
Exclusion Criteria:
- No medical care
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Bicetre | Le Kremlin-Bicêtre | France | 94275 |
Sponsors and Collaborators
- Bicetre Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-A01740-51