Status:
TERMINATED
Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Hysterectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional mul...
Detailed Description
The secondary objectives are to compare the following between the two arms of the study: 1. the difference between the real discharge date and the theoretical discharge date 2. measures related to in...
Eligibility Criteria
Inclusion
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The patient is declared fit by the anesthetist for an intervention by laparoscopy
Exclusion
- The patient is not available for 12 months of follow-up
- The patient is participating in another study or is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient is not insured or beneficiary of a health insurance plan
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient cannot read French
- Patient with a history of pelvic radiotherapy
- Patient with a history of pelvic surgery or serious risk of major adhesions
- The patient is pregnant
- Contraindications for anesthesia for either surgical technique
- Promontofixation or lymphadenectomy
- No associated procedure other than morcellation or vaginal suture for extracting the hysterectomy specimen, unilateral or bilateral oophorectomy
- The patient has a known or suspected allergy to polyurethane
- Extended hysterectomy for neoplastic disease
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01830738
Start Date
February 1 2014
End Date
April 1 2015
Last Update
October 22 2015
Active Locations (3)
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1
APHM - Hôpital de la Conception
Marseille, France, 13385
2
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029
3
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, France, 42270