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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03095716

Enrollment

Registered

2017-03-30

Start date

2016-10-31

Completion date

2018-12-31

Last updated

2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Prolapse

Keywords

Carbon dioxide pneumoperitoneum, Intraperitoneal pressure, Post-operative recovery, Laparoscopic Humidification System

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.

Interventions

OTHERlaparoscopic surgery

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

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

75 Years to No maximum

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

Exclusion criteria

* BMI more than 30 * Height less than 150cm

Design outcomes

Primary

Measure	Time frame
Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire	at 24h 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

Measure	Time frame
post operative complications	at 24h post-operatively
Intraoperative core temperature	at 24h post-operatively

Countries

France

Contacts

Primary ContactPatrick LACARIN

placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026