NCT05323604

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

April 5, 2022

Last Update Submit

September 3, 2024

Conditions

Keywords

Sarcopeniacolorectal neoplasmcolorectal surgerypsoas muscles

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Comparison between complication rate in sarcopenic and non sarcopenic patients

    At the end of the 30 post-operative days

  • Assessment of re-hospitalization rate between sarcopenic and non sarcopenic patients

    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

    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

    At the end of the 30 post-operative days

Study Arms (1)

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

Interventions

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

Colectomy with anastomosis of any type

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from sarcopenia who had colorectal surgery for cancer.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier René Dubos

Pontoise, 95300, France

Location

MeSH Terms

Conditions

SarcopeniaColorectal Neoplasms

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hicham El Masri

    Hospital René Dubos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 12, 2022

Study Start

March 1, 2022

Primary Completion

May 6, 2022

Study Completion

May 31, 2022

Last Updated

September 19, 2024

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations