Study of Outpatient Management for Promontofixation by Laparoscopy

University Hospital, Strasbourg, France

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Other: outpatient management for promontofixation by laparoscopy

Other: questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT03573752

6796

Details and patient eligibility

About

Laparoscopic promontofixation is becoming increasingly common and is currently the standard surgical procedure for pelvic prolapse, with few complications including exposure and mesh infection.

The research hypothesis is that laparoscopic promontofixation is a relatively painless procedure and can be performed on an outpatient basis without increasing the number of postoperative complications and impairing patients' quality of life.

The objective of this study is to evaluate the number of rehospitalizations after management of promontofixation by laparoscopy on an outpatient basis.

To evaluate the feasibility of a postoperative H8 exit after laparoscopic promontofixation.

Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.

Enrollment

60 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Woman with promontofixation indication by laparoscopy for prolapse cure
Patient's desire for outpatient management
Age ≥18 years and <70 years
Absence of a major medical or surgical history that would prolong hospitalization (ASA 1 or 2, absence of Obstructive Sleep Apnea Syndrome)
Subject affiliated to a social security scheme
Subject having signed an informed consent
Availability of a caregiver, responsible and valid (for the first 48 hours after the potential early exit) at home
Geographical distance less than one hour from a suitable care facility
Access to a telephone or a means of transport if necessary
Patient compliance
Oral and written comprehension of pre- and post-operative instructions
Correct housing condition
Subject having been informed of the results of the prior medical examination

Exclusion criteria

Laparoscopic contraindication
Comorbidity needs of medical supervision most of 24h
TVT-O procedure during the same surgery
Mental handicap affecting autonomy
Comprehension difficulties to understand the protocol
No social protection
Subject with curatorship or guardianship
Morbid obesity
Alcohol or drugs addiction
Excessive anxiety
Impossibility to give the subject enlightened information (subject in emergency situation...)
Pregnant woman (positive urinary pregnancy test for women of childbearing age)