Clinical trial NCT03573752: Study of Outpatient Management for Promontofixation by Laparoscopy
Official title: Study of Outpatient Management for Promontofixation by Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Laparoscopic Promontofixation
Outpatient management
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Rate of rehospitalizations occurring between outpatient discharge and postoperative follow-up consultation
timeFrame: 35 to 70 Days after the intervention
Secondary outcomes:
measure: Exit rate at postoperative H8 according to post-anesthesia discharge scoring system score according to Chung.
timeFrame: Hour 8 after the intervention
measure: Quality of life assessed by the Euroqol EQ-5D index (EuroQol five dimension scale)
timeFrame: Day 0, 3, 7 and 30 after the intervention
measure: Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire
timeFrame: Day 30 after the intervention
measure: Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A.
timeFrame: Day 0, 1, 2, 3, 7 and 30 after the intervention
measure: Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics.
timeFrame: 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)
measure: Rates of postoperative complications
timeFrame: 35 to 70 Days after the intervention
measure: Number of emergency consultations before scheduled postoperative follow-up consultation
timeFrame: 35 to 70 Days after the intervention
measure: Difference in actual costs and cost-effectiveness between conventional and outpatient care
timeFrame: 35 to 70 Days after the intervention
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires de Strasbourg
Study officials:
References: