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

NCT03402516 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2021-01-27

No results posted yet for this study

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.

Conditions

  • Rate of Complete Resection in a Unique Surgical Time

Interventions

DEVICE

18.5 resector

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

DEVICE

26Fr resector

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

Sponsors & Collaborators

  • Bicetre Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03402516 on ClinicalTrials.gov