Laparoscopic Surgery in Elderly Patients

• Conditions: Uterine Prolapse

• Registration Number: NCT03095716
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-03
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-03-30
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 word until discharge	at 24h post-operatively
Post-operative pain assessed by visual analogue scale in the postanesthesia care unit	at 24h post-operatively

Secondary Outcome Measures

Name	Time	Method
post operative complications	at 24h post-operatively
Intraoperative core temperature	at 24h post-operatively

Trial Locations

Locations (1)

CHU Clermont-ferrand; 🇫🇷 Clermont-Ferrand, France