Skip to main content
OpenTrials
Completed

NCT Number: NCT03573752

Study of Outpatient Management for Promontofixation by Laparoscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Schiltigheim, 67303, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 35 to 70 Days after the intervention

    Rate of rehospitalizations occurring between outpatient discharge and postoperative

Secondary outcomes

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

    Time frame: Hour 8 after the intervention

    This score considers six criteria: vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a score of 9 or more are considered ready for discharge.

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

    Time frame: Day 0, 3, 7 and 30 after the intervention

    The EQ-5D questionnaire is made up for two components; health state description and evaluation. In description part, health status is measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (3L) scale; having no problems, having some or moderate problems, being unable to do/having extreme problems. The respondents are asked to choose the statement which best describes their health status of surveyed day.

    In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS). The patient is asked to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to "the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".

  3. Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire

    Time frame: Day 30 after the intervention

    Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire. It includes a satisfaction scale ranging from 0 to 10 and 2 closed-response questions, with the possibility of adding a free comment.

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

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

    Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A. This form has 20 items for assessing state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety.

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

    Time frame: 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)

    Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics. This scale consists of a straight line with the endpoints defining extreme limits such as "no pain at all" and "pain as bad as it could be". The patient is asked to mark his pain level on the line between the two endpoints. The distance between "no pain at all" and the mark then defines the subject's pain.

  6. Rates of postoperative complications

    Time frame: 35 to 70 Days after the intervention

    Rates of postoperative complications

  7. Number of emergency consultations before scheduled postoperative follow-up consultation

    Time frame: 35 to 70 Days after the intervention

    Number of emergency consultations before scheduled postoperative follow-up consultation

  8. Difference in actual costs and cost-effectiveness between conventional and outpatient care

    Time frame: 35 to 70 Days after the intervention

    Collection of the PMSI (medical information system program) of the made act and the cost of the hospital stay in ambulatory for a laparoscopic promontofixation.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2018
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.