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Laparoscopic Surgery in Elderly Patients

NCT ID: NCT03095716

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Uterine Prolapse

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

laparoscopic surgery

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Revaz Botchorishvili

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

Phone: 04 73 75 11 95

Email: [email protected]

Facility Contacts

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Patrick LACARIN

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32979535 (View on PubMed)

Other Identifiers

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CHU-310

Identifier Type: -

Identifier Source: org_study_id