Evaluation of a Hysteroscopic Morcellator in Hysteroscopic Treatment of Submucosal Fibroids

Study Overview
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Brief Summary
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Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma. Limit of this technic is duration of procedure which is correlated to operative complications. So, for patient with large fibrome or several fibromas, this technic is not indicated or performs in several times. A new technic of hysteroscopic surgery is available which is quicker than conventional technic. This technic is poorly evaluated. Aim of this study is to evaluate both technics on procedure duration.

Detailed Description
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Material and Methods We propose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring hysteroscopic surgery for fibroma. After informed consent, patients will be randomised in two groups: hysteroscopic surgery with morcellation technic and conventional hysteroscopy technic with resection. The main objective is duration of procedure. Secondary objectives are characteristics and perioperative complications (distension media quantity, cervical injury, uterine perforation), immediate et long term postoperative data's (postoperative pain and synechia). We hypothesis hysteroscopic with morcellation reduces duration of procedure of 50%. The estimated size of population number is 30 per group and 60 for the study. Expected results We expected a significant decrease of procedure duration with hysteroscopic morcellation. This data will be interesting according peroperative complications are correlated to procedure duration and allow hysteroscopic surgery to patients with large or several fibromas.

Official Title
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Operative Hysteroscopy for Fibroma by Classic Resection Versus Morcellation: a Ramdomised Study

Conditions
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Evaluate Both Technics on Procedure Duration, Characteristics and Perioperative Complications

Intervention / Treatment
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* Device: morcellator uterine system (MH)Karl Storz, Tuttligen- Germany


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:- Patient who is at least 18 years. Patient under effective contraception. Patient who underwent ultrasound confirming the presence of at least one or both uterine fibroids with a diameter less than 6 cm for the largest fibroid. Patient who underwent diagnostic hysteroscopy confirming the presence of one or two uterine fibroids classified as Type 0, 1 or 2 according to FIGO classification (10). Patient with an indication of intrauterine fibroid resection (bleeding disorders fetilité) by hysteroscopy. Patient who agreed to participate in the study and who signed informed consent. Exclusion Criteria: Early Removal linked to patient's wish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hysteroscopic surgery with morcellation technic<br>The hysteroscope with the MH system will be introduced. Resection of fibroids or both will be realized. The procedure will end or when the fibroids will be completely resected. the procedure may be suspended before complete resection of fibroids or uterine perforation or higher operating time to 90 minutes or amount of liquid used distension than 9 liters or distension fluid deficit of more than one liter . | Device: morcellator uterine system (MH)Karl Storz, Tuttligen- Germany<br> <br> |
| Active Comparator: conventional hysteroscopy technic with resection.<br>The hysteroscope with conventional resection system will be introduced. Resection of fibroids or both will be realized. The procedure will end or when the fibroids will be completely resected. the procedure may be suspended before complete resection of fibroids or uterine perforation or higher operating time to 90 minutes or amount of liquid used distension than 9 liters or distension fluid deficit of more than one liter (4 ). | Device: morcellator uterine system (MH)Karl Storz, Tuttligen- Germany<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of procedure | The duration of the operative hysteroscopy is the period between the first introduction and the last out of the hysteroscope. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distension fluid amount used during hysteroscopy |  | intraoperative | 
| Cervical tear |  | intraoperative | 
| The stopping rate of operative hysteroscopy before complete resection: |  | intraoperative | 
| Postoperative pain upon awakening on a visual scale 0-10 |  | 6 hours after end of procedure | 
| The postoperative adhesions rate diagnosed by hysteroscopy control |  | 1 month |