Study of Outpatient Management for Promontofixation by Laparoscopy

Pelvic Organ Prolapse Clinical Trial

Official title:

Study of Outpatient Management for Promontofixation by Laparoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573752
• Other study ID #: 6796
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: October 14, 2021

Study information

• Verified date: August 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• outpatient management for promontofixation by laparoscopy
postoperative H8 exit after laparoscopic promontofixation
• questionnaire
Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.

Locations

Country	Name	City	State
France	Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires de Strasbourg	Schiltigheim

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Exit rate at postoperative H8 according to post-anesthesia discharge scoring system score according to Chung.	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.	Hour 8 after the intervention
Secondary	Quality of life assessed by the Euroqol EQ-5D index (EuroQol five dimension scale)	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".	Day 0, 3, 7 and 30 after the intervention
Secondary	Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire	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.	Day 30 after the intervention
Secondary	Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A.	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.	Day 0, 1, 2, 3, 7 and 30 after the intervention
Secondary	Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics.	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.	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)
Secondary	Rates of postoperative complications	Rates of postoperative complications	35 to 70 Days after the intervention
Secondary	Number of emergency consultations before scheduled postoperative follow-up consultation	Number of emergency consultations before scheduled postoperative follow-up consultation	35 to 70 Days after the intervention
Secondary	Difference in actual costs and cost-effectiveness between conventional and outpatient care	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.	35 to 70 Days after the intervention