Clinical trial NCT03095716: Laparoscopic Surgery in Elderly Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Prolapse
Keywords: Carbon dioxide pneumoperitoneum
Intraperitoneal pressure
Post-operative recovery
Laparoscopic Humidification System
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ederly patients who undergo laparoscopic surgery for uterine prolapse

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire
timeFrame: at 24h post-operatively
measure: Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire
timeFrame: at 48h post-operatively
measure: Post-operative pain assessed by visual analogue scale in the postanesthesia care unit
timeFrame: at 24h post-operatively
measure: Post-operative pain assessed by visual analogue scale in the word until discharge
timeFrame: at 24h post-operatively
Secondary outcomes:
measure: post operative complications
timeFrame: at 24h post-operatively
measure: Intraoperative core temperature
timeFrame: at 24h post-operatively
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Revaz Botchorishvili
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matsuzaki S, Bonnin M, Fournet-Fayard A, Bazin JE, Botchorishvili R. Effects of Low Intraperitoneal Pressure on Quality of Postoperative Recovery after Laparoscopic Surgery for Genital Prolapse in Elderly Patients Aged 75 Years or Older. J Minim Invasive Gynecol. 2021 May;28(5):1072-1078.e3. doi: 10.1016/j.jmig.2020.09.017. Epub 2020 Sep 24.