NCT03095716

Laparoscopic Surgery in Elderly Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Prolapse

Interventions

Type	Name	Description
OTHER	laparoscopic surgery	Impact of intraperitoneal pressure and warmed, humidified CO2 gas on clinical outcomes after laparoscopic surgery for uterine prolapse in patients aged ˃75 years

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2017-03-30
• Last updated: 2017-03-31

Locations

1 site across 1 country: France