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Study of Outpatient Management for Promontofixation by Laparoscopy

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
outpatient management for promontofixation by laparoscopy
questionnaire
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Organ Prolapse focused on measuring Laparoscopic Promontofixation, Outpatient management

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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".
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.
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.
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.
Rates of postoperative complications
Rates of postoperative complications
Number of emergency consultations before scheduled postoperative follow-up consultation
Number of emergency consultations before scheduled postoperative follow-up consultation
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.

Full Information

First Posted
April 5, 2018
Last Updated
August 17, 2022
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03573752
Brief Title
Study of Outpatient Management for Promontofixation by Laparoscopy
Official Title
Study of Outpatient Management for Promontofixation by Laparoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Laparoscopic Promontofixation, Outpatient management

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
outpatient management for promontofixation by laparoscopy
Intervention Description
postoperative H8 exit after laparoscopic promontofixation
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Description
Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.
Primary Outcome Measure Information:
Title
Rate of rehospitalizations occurring between outpatient discharge and postoperative follow-up consultation
Description
Rate of rehospitalizations occurring between outpatient discharge and postoperative
Time Frame
35 to 70 Days after the intervention
Secondary Outcome Measure Information:
Title
Exit rate at postoperative H8 according to post-anesthesia discharge scoring system score according to Chung.
Description
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.
Time Frame
Hour 8 after the intervention
Title
Quality of life assessed by the Euroqol EQ-5D index (EuroQol five dimension scale)
Description
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".
Time Frame
Day 0, 3, 7 and 30 after the intervention
Title
Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire
Description
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.
Time Frame
Day 30 after the intervention
Title
Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A.
Description
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.
Time Frame
Day 0, 1, 2, 3, 7 and 30 after the intervention
Title
Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics.
Description
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.
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)
Title
Rates of postoperative complications
Description
Rates of postoperative complications
Time Frame
35 to 70 Days after the intervention
Title
Number of emergency consultations before scheduled postoperative follow-up consultation
Description
Number of emergency consultations before scheduled postoperative follow-up consultation
Time Frame
35 to 70 Days after the intervention
Title
Difference in actual costs and cost-effectiveness between conventional and outpatient care
Description
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.
Time Frame
35 to 70 Days after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires de Strasbourg
City
Schiltigheim
ZIP/Postal Code
67303
Country
France

12. IPD Sharing Statement

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Study of Outpatient Management for Promontofixation by Laparoscopy

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