Laparoscopic Surgery in Elderly Patients

Uterine Prolapse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03095716
• Other study ID #: CHU-310
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: March 30, 2017
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire		at 24h post-operatively
Primary	Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire		at 48h post-operatively
Primary	Post-operative pain assessed by visual analogue scale in the postanesthesia care unit		at 24h post-operatively
Primary	Post-operative pain assessed by visual analogue scale in the word until discharge		at 24h post-operatively
Secondary	post operative complications		at 24h post-operatively
Secondary	Intraoperative core temperature		at 24h post-operatively