Characteristics and Perioperative Complications, Evaluate Both Technics on Procedure Duration
Conditions
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.
Interventions
DEVICEmorcellator uterine system (MH)Karl Storz, Tuttligen- Germany
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of procedure | intraoperative | The duration of the operative hysteroscopy is the period between the first introduction and the last out of the hysteroscope. |
Secondary
| 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 |
Countries
France
Contacts
Primary ContactAubert AGOSTINI
Outcome results
None listed