SarcopeniaISEPAMNCT05323604
Impact of Sarcopenia Using an Easy Psoas Area Measurement
An observational study of Sarcopenia, run by Hôpital NOVO at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Colectomy with anastomosis of any type
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from sarcopenia who had colorectal surgery for cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Colectomy with anastomosis of any type
- Keywords
- Sarcopenia, colorectal neoplasm, colorectal surgery, psoas muscles
- Medical subject headings
- Sarcopenia, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colectomy with anastomosis of any typeOther
Patient with colonic resection followed by ileocolic, or colo colic, or colorectal, or coloanal anastomosis for cancer by laparoscopy or laparotomy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Colectomy with anastomosis of any type |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Until discharge from hospital, an average of 30 days
Secondary outcomes (4)
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
Measured: At the end of the 30 post-operative days
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
Measured: 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
Evaluation of the number of transfer to rehabilitation or nursing home center at 30 days after the operation between the two groups
Measured: 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
Comparison of the number of hospital days for transferred patients between the two groups
Measured: At the end of the 30 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Mar 2022
- Primary completion6 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hicham El Masri, Principal investigator, Hospital René Dubos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323604
- Sponsor's protocol ID
- CHRD3021
- Acronym
- ISEPAM
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05323604
- Acronym / sponsor ID
- ISEPAM / CHRD3021
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, colorectal neoplasm, colorectal surgery, psoas muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colectomy with anastomosis of any type | – | Other: Colectomy with anastomosis of any typePatient with colonic resection followed by ileocolic, or colo colic, or colorectal, or coloanal anastomosis for cancer by laparoscopy or laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from sarcopenia who had colorectal surgery for cancer.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colectomy with anastomosis of any typePatient 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 |
Primary outcome
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
4 secondary outcomes
Comparison between complication rate in sarcopenic and non sarcopenic patients
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hicham El Masri principal investigator
Hospital René Dubos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.