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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires de Strasbourg | Schiltigheim | 67303 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38663686 | Result | Collin-Bund V, Viviani V, Meyer N, Goetsch T, Boisrame T, Faller E, Lecointre L, Gabriele V, Akladios C, Garbin O, Host A. Study of the feasibility of outpatient sacrocolpopexy by laparoscopy. J Gynecol Obstet Hum Reprod. 2024 Sep;53(7):102792. doi: 10.1016/j.jogoh.2024.102792. Epub 2024 Apr 23. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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 |
| 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 |
| 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 |
| 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) |
| Rates of postoperative complications | Rates of postoperative complications | 35 to 70 Days after the intervention |
| 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 |
| 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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |