Laparoscopic Surgery in Elderly Patients

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 2018

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • post operative complications
    • Time Frame: at 24h post-operatively
  • Intraoperative core temperature
    • Time Frame: at 24h post-operatively

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Revaz Botchorishvili, Principal Investigator, University Hospital, Clermont-Ferrand
  • Overall Contact(s)
    • Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.