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Study of Outpatient Management for Promontofixation by Laparoscopy

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ClinicalTrials.gov Identifier: NCT03573752
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: outpatient management for promontofixation by laparoscopy Other: questionnaire Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Outpatient Management for Promontofixation by Laparoscopy
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022
Arms and Interventions
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Intervention Details:
  • Other: outpatient management for promontofixation by laparoscopy
    postoperative H8 exit after laparoscopic promontofixation
  • Other: questionnaire
    Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573752


Contacts
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Contact: Aline HOST, MD 3 88 15 48 54 ext 0033 aline.felder@chru-strasbourg.fr

Locations
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France
Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires de Strasbourg Recruiting
Schiltigheim, France, 67303
Contact: Aline HOST, MD    03 88 15 48 54    Aline.HOST@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03573752    
Other Study ID Numbers: 6796
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Laparoscopic Promontofixation
Outpatient management
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical