Evaluation of a Hysteroscopic Morcellator in Hysteroscopic Treatment of Submucosal Fibroids

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

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.

Study Overview

• Status: Unknown
• Conditions: Evaluate Both Technics on Procedure Duration; Characteristics and Perioperative Complications
• Intervention / Treatment: Device: morcellator uterine system (MH)Karl Storz, Tuttligen- Germany

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Hôpital de la Conception
    • Contact: Aubert Agostini, MD; Phone Number: 04.91.38.37.85; Email: aubert.agostini@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hysteroscopic surgery with morcellation technic; 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
Active Comparator: conventional hysteroscopy technic with resection.; 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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2014-43