Impact of Sarcopenia Using an Easy Psoas Area Measurement (ISEPAM)

June 16, 2022 updated by: Centre Hospitalier René Dubos

Impact of Sarcopenia on Post-operative Course for Cancer Patients Operated of Colorectal Surgery Using a Simple Measurement Method of the Psoas Muscle Surface Area

The purpose of this study is to compare the post-operative course in patients suffering from sarcopenia who had colorectal surgery for cancer. Our primary outcome is the comparaison of the length of hospital stay in sarcopenic and non sarcopenic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sarcopenia is the loss of muscle mass that occurs usually with aging, but it may have multiple contributing factors, especially related to chronic diseases such as colorectal cancer.

When present, sarcopenia is predictive of poor post-operative course. The identification of sarcopenia needs either the identification of low muscle strength, low muscle quantity/quality, or finally a low physical performance.

Multiple clinical, biological or radiological tools were proposed. Our purpose is to compare the post-operative outcome of sarcopenic and non sarcopenic patients using a simple, available, reproducible and rapid radiological method, which will help the healthcare professionals to rapidly identify high risk patients for possible complicated and long post-operative course allowing them to take appropriate perioperative measures to reduce the risks.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pontoise, France, 95300
        • Centre Hospitalier Rene Dubos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from sarcopenia who had colorectal surgery for cancer.

Description

Inclusion Criteria:

  • Patient operated on for colectomy or proctectomy with restoration of continuity for colorectal cancer between 1 January 2020 and 31 December 2021
  • Patient who had a CT scan in the 2 months prior surgery
  • Patient aged 18 years or older

Exclusion Criteria:

  • Patients with inflammatory bowel disease (Crohn disease, haemorrhagic rectocolitis)
  • Patients with neuromuscular pathology affecting their mobility
  • Patients who were diagnosed positif to SARS COV 2 before or during hospitalisation
  • Patients who refuse the collection of their data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colectomy with anastomosis of any type
Patient with colonic resection followed by ileocolic, or colo colic, or colorectal, or coloanal anastomosis for cancer by laparoscopy or laparotomy
Other: Colectomy with anastomosis of any type
Patient with colonic resection followed by ileocolic, or colo colic, or colorectal, or coloanal anastomosis for cancer by laparoscopy or laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the average postoperative length of stay in sacopenic and non-sarcopenic patients
Time Frame: Until discharge from hospital, an average of 30 days
Comparison of the number of post-operative hospital days between the two groups
Until discharge from hospital, an average of 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between complication rate in sarcopenic and non sarcopenic patients
Time Frame: At the end of the 30 post-operative days
Measurement of the complication rate according to the Clavien Dindo score (relevant score if greater than or equal to 2, considered severe complication if greater than or equal to 3) between the two groups
At the end of the 30 post-operative days
Assessment of re-hospitalization rate between sarcopenic and non sarcopenic patients
Time Frame: At the end of the 30 post-operative days
Evaluation of the number of hospitalizations of more than 24 hours at 30 days after the operation between the two groups
At the end of the 30 post-operative days
Comparison of the transfer rate to rehabilitation or nursing home center between sarcopenic and non sarcopenic patients
Time Frame: At the end of the 30 post-operative days
Evaluation of the number of transfer to rehabilitation or nursing home center at 30 days after the operation between the two groups
At the end of the 30 post-operative days
Comparison of the length of stay in the rehabilitation center for sarcopenic and non sarcopenic transferred patients
Time Frame: At the end of the 30 post-operative days
Comparison of the number of hospital days for transferred patients between the two groups
At the end of the 30 post-operative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: Hicham El Masri, Hospital René Dubos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

May 6, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD3021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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