Impact of Sarcopenia Using an Easy Psoas Area Measurement

Sarcopenia Clinical Trial

— ISEPAM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05323604
• Other study ID #: CHRD3021
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2022
• Source: Centre Hospitalier René Dubos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 31, 2022
• Est. primary completion date: May 6, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier René Dubos	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

References & Publications (4)

Langdon RB, Freeman JA. Pharmacology of retinotectal transmission in the goldfish: effects of nicotinic ligands, strychnine, and kynurenic acid. J Neurosci. 1987 Mar;7(3):760-73. — View Citation

Miyagi K, Koh CS, Inoue A, Tsukada N, Yanagisawa N. [A case of dysthyroid ophthalmopathy with chronic thyroiditis and anti-extraocular muscle antibody]. Rinsho Shinkeigaku. 1988 Apr;28(4):396-400. Japanese. — View Citation

Raab W. [Occupational dermatoses: clinical picture, noxious compounds, prevention]. Wien Med Wochenschr. 1989 Nov 30;139(22):515-8. Review. German. — View Citation

Wing JS, Brender JD, Sanderson LM, Perrotta DM, Beauchamp RA. Acute health effects in a community after a release of hydrofluoric acid. Arch Environ Health. 1991 May-Jun;46(3):155-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the average postoperative length of stay in sacopenic and non-sarcopenic patients	Comparison of the number of post-operative hospital days between the two groups	Until discharge from hospital, an average of 30 days
Secondary	Comparison between complication rate in sarcopenic and non sarcopenic patients	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
Secondary	Assessment of re-hospitalization rate between sarcopenic and non sarcopenic patients	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
Secondary	Comparison of the transfer rate to rehabilitation or nursing home center between sarcopenic and non sarcopenic patients	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
Secondary	Comparison of the length of stay in the rehabilitation center for sarcopenic and non sarcopenic transferred patients	Comparison of the number of hospital days for transferred patients between the two groups	At the end of the 30 post-operative days