NCT02406898

Evaluation of a Hysteroscopic Morcellator in Hysteroscopic Treatment of Submucosal Fibroids

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Evaluate Both Technics on Procedure Duration
• Characteristics and Perioperative Complications

Interventions

Type	Name	Description
DEVICE	morcellator uterine system (MH)Karl Storz, Tuttligen- Germany

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-03-01
• Completion: 2018-03-01
• First posted: 2015-04-02
• Last updated: 2015-09-29

Locations

1 site across 1 country: France