Laparoscopic Surgery in Elderly Patients

Study Overview
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Brief Summary
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The primary purpose is to evaluate the quality of post-operative recovery and post-operative pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine prolapse.

Detailed Description
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Previous randomized clinical trial (NCT01887028) showed that the combined use of a low intraperitoneal pressure and a warmed, humidified CO2 gas resulted in better clinical outcomes (better quality of post-operative recovery and less post-operative pain) in patients aged 45-75 years, who underwent laparoscopic surgery for uterine prolapse. Quality of post-operative recovery is very important in elderly patients. Investigators hypothesize that the combined use of a low intraperitoneal pressure and a warmed, humidified CO2 gas may also result in better clinical outcomes. In this observational clinical trial, quality of post-operative recovery by QoR-40, post-operative pain by Visual Analog Scale, intra or postoperative complications and intraoperative core temperature are evaluated in elderly patients (more than 75 years old) who undergo laparoscopic surgery for uterine prolapse. Investigators use a low intraperitoneal pressure (6 mmHg) and a warmed, humidified CO2 gas during laparoscopy. These outcomes will be compared with those of previous randomized clinical trial.

Official Title
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Impact of Intraperitoneal Pressure and Warmed, Humidified CO2 Gas on Clinical Outcomes After Laparoscopic Surgery for Uterine Prolapse in Patients Aged ˃75 Years: A Observational Study

Conditions
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Uterine Prolapse

Intervention / Treatment
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* Other: laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 75 years old Patients undergoing laparoscopic promontofixation with or without sub-total hysterectomy for uterine prolapse ASA class I or II Exclusion Criteria: BMI more than 30 Height less than 150cm

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| elderly patients<br>Impact of intraperitoneal pressure and warmed, humidified CO2 gas on clinical outcomes after laparoscopic surgery for uterine prolapse in patients aged ˃75 years | Other: laparoscopic surgery<br>* Impact of intraperitoneal pressure and warmed, humidified CO2 gas on clinical outcomes after laparoscopic surgery for uterine prolapse in patients aged ˃75 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire |  | at 24h post-operatively | 
| Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire |  | at 48h post-operatively | 
| Post-operative pain assessed by visual analogue scale in the postanesthesia care unit |  | at 24h post-operatively | 
| Post-operative pain assessed by visual analogue scale in the word until discharge |  | at 24h post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative complications |  | at 24h post-operatively | 
| Intraoperative core temperature |  | at 24h post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbon dioxide pneumoperitoneum, Intraperitoneal pressure, Post-operative recovery, Laparoscopic Humidification System