Laparoscopic Surgery in Elderly Patients

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT03095716

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Prolapse	Other: laparoscopic surgery

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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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	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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

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

post operative complications [at 24h post-operatively]
Intraoperative core temperature [at 24h post-operatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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