Clinical trial NCT02406898: Evaluation of a Hysteroscopic Morcellator in Hysteroscopic Treatment of Submucosal Fibroids
Official title: Operative Hysteroscopy for Fibroma by Classic Resection Versus Morcellation: a Ramdomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluate Both Technics on Procedure Duration
Characteristics and Perioperative Complications
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: duration of procedure
timeFrame: intraoperative
Secondary outcomes:
measure: Distension fluid amount used during hysteroscopy
timeFrame: intraoperative
measure: Cervical tear
timeFrame: intraoperative
measure: The stopping rate of operative hysteroscopy before complete resection:
timeFrame: intraoperative
measure: Postoperative pain upon awakening on a visual scale 0-10
timeFrame: 6 hours after end of procedure
measure: The postoperative adhesions rate diagnosed by hysteroscopy control
timeFrame: 1 month
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la conception
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References: