Study of Outpatient Management for Promontofixation by Laparoscopy

NCT ID: NCT03573752

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2021-12-30

Brief Summary

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.

Conditions

Pelvic Organ Prolapse

Keywords

Laparoscopic Promontofixation; Outpatient management

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

outpatient management for promontofixation by laparoscopy

postoperative H8 exit after laparoscopic promontofixation

Intervention Type: OTHER

questionnaire

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires de Strasbourg

Schiltigheim, , France

Countries

France

References

Collin-Bund V, Viviani V, Meyer N, Goetsch T, Boisrame T, Faller E, Lecointre L, Gabriele V, Akladios C, Garbin O, Host A. Study of the feasibility of outpatient sacrocolpopexy by laparoscopy. J Gynecol Obstet Hum Reprod. 2024 Sep;53(7):102792. doi: 10.1016/j.jogoh.2024.102792. Epub 2024 Apr 23.

Reference Type: RESULT

PMID: 38663686 (View on PubMed)

Other Identifiers

6796

Identifier Type: -

Identifier Source: org_study_id