NCT03095716

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

March 20, 2017

Last Update Submit

March 30, 2017

Conditions

Uterine Prolapse

Keywords

Carbon dioxide pneumoperitoneumIntraperitoneal pressurePost-operative recoveryLaparoscopic Humidification System

Outcome Measures

Primary Outcomes (4)

  • Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire

    at 24h post-operatively

  • Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire

    at 48h 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 Outcomes (2)

  • post operative complications

    at 24h post-operatively

  • Intraoperative core temperature

    at 24h post-operatively

Study Arms (1)

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

Other: laparoscopic surgery

Interventions

laparoscopic surgeryOTHER

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

elderly patients

Eligibility Criteria

Age75 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ederly patients who undergo laparoscopic surgery for uterine prolapse

You may qualify if:

  • Age more than 75 years old
  • Patients undergoing laparoscopic promontofixation with or without sub-total hysterectomy for uterine prolapse
  • ASA class I or II

You may not qualify if:

  • BMI more than 30
  • Height less than 150cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32979535DERIVED

MeSH Terms

Conditions

Uterine Prolapse

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Revaz Botchorishvili

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 30, 2017

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

FR(1)