Study of Outpatient Management for Promontofixation by Laparoscopy

NCT03573752 | Completed

• 1 other identifier: 6796
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of rehospitalizations occurring between outpatient discharge and postoperative follow-up consultation

  Rate of rehospitalizations occurring between outpatient discharge and postoperative

  35 to 70 Days after the intervention

Secondary Outcomes (8)

• Exit rate at postoperative H8 according to post-anesthesia discharge scoring system score according to Chung.

  Hour 8 after the intervention

• Quality of life assessed by the Euroqol EQ-5D index (EuroQol five dimension scale)

  Day 0, 3, 7 and 30 after the intervention

• Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire

  Day 30 after the intervention

• Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A.

  Day 0, 1, 2, 3, 7 and 30 after the intervention

• Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics.

  8 hours after surgery (Day 0)/ At 8 a.m. and 6 p.m. (Day 1, 2 and 3)/ At 8 a.m. (Day 4, 5, 6, 7 and 30)

Interventions

outpatient management for promontofixation by laparoscopy OTHER

postoperative H8 exit after laparoscopic promontofixation

questionnaire OTHER

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Schiltigheim, 67303, France

Location

Related Publications (1)

• 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.

  PMID: 38663686 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: June 29, 2018
• Study Start: July 26, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)