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Completed

NCT Number: NCT05323604

Impact of Sarcopenia Using an Easy Psoas Area Measurement

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colectomy with anastomosis of any type

Other

Patient with colonic resection followed by ileocolic, or colo colic, or colorectal, or coloanal anastomosis for cancer by laparoscopy or laparotomy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: ISEPAM

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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