- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04762914
Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer Patients
Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer
Study Overview
Detailed Description
The aim was to evaluate how prehabilitation (PH) can be incorporated into our colorectal cancer pathway and assess its clinical benefits.
Patients underwent PH (exercise, nutrition and psychological support) before resection of colorectal carcinoma in a DGH over fourteen months. Patients were matched by operation, age, sex and ASA to non-prehabilitation (NPH) patients using a prospectively maintained database. Length of stay (LoS) and complication rate and 90-day readmission rates were compared using Wilcoxon and McNemar's methods.
Prehabilitation significantly improved peak VO2 and AT. This corresponds to a reduction in predicted 30-day mortality. Despite a higher Charlson index LoS was unchanged suggesting prehabilitation may permit safe resection in comorbid patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kent
-
Gillingham, Kent, United Kingdom, ME7 5NY
- Medway Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults over the age of 18 who had prehabilitation for colorectal cancer
Exclusion Criteria:
- Children
- Patients who had prehabilitation but not for colorectal cancer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prehabilitation (PH)
Patients who underwent prehabilitation prior to colorectal cancer resection
|
Prehabilitation is a multimodal and multidisciplinary person-centred perioperative approach involving supervised exercise training, nutritional education, management of polypharmacy and psychological advice.
|
|
Non-Prehabilitation (NPH)
Patients who did not undergo prehabilitation prior to colorectal cancer resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay
Time Frame: From date of operation to date of discharge in number of days over a 90 day follow up period
|
Time spent in hospital
|
From date of operation to date of discharge in number of days over a 90 day follow up period
|
|
Complication rate
Time Frame: Follow up over a period of 90 days following operation
|
All Clavien-Dindo complications
|
Follow up over a period of 90 days following operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anaerobic threshold
Time Frame: CPET performed before prehabilitation and after prehabilitation (median of 36 days)
|
Measured by looking at CPET results pre- and post- prehab
|
CPET performed before prehabilitation and after prehabilitation (median of 36 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard A Dickson-Lowe, Medway PCT
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021.038N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Colon Cancer
-
Chaoxi ZhouRecruitingProximal Transverse Colon Cancer | Ascending Colon CancerChina
-
Gruppo Oncologico del Nord-OvestSeagen Inc.; Servier; Foundation MedicineSuspendedStage II Colon Cancer | Stage III Colon Cancer | HER2-positive Colon Cancer | RAS Wild-type Colon CancerItaly
-
Chang Gung Memorial HospitalCompletedColon Cancer | Cancer Recurrence | Colon Adenocarcinoma | Colon Cancer Stage II | Colon Cancer Stage I | Survival Analysis | Colon Cancer Stage IIITaiwan
-
National Cancer Institute (NCI)NSABP Foundation IncCompletedColon Adenocarcinoma | Stage IIIA Colon Cancer AJCC v7 | Stage IIIB Colon Cancer AJCC v7 | Stage IIIC Colon Cancer AJCC v7 | Stage IIA Colon Cancer AJCC v7 | Stage IIB Colon Cancer AJCC v7 | Stage IIC Colon Cancer AJCC v7United States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedFatigue | Depressive Symptoms | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Psychosocial Effects of Cancer and Its Treatment | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage I Colon Cancer | Stage... and other conditionsUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingStage III Colon Cancer AJCC v8 | Colon Adenocarcinoma | Microsatellite Stable Colon Carcinoma | Stage IIB Colon Cancer AJCC v8 | Stage IIC Colon Cancer AJCC v8United States
-
Hospital da Senhora da OliveiraCompletedColon Cancer | Colon Adenoma | Colon Polyp | Colon Rectal CancerPortugal
-
National Cancer Institute (NCI)CompletedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer | Stage IVB Colon Cancer | Stage IVB Rectal CancerUnited States
Clinical Trials on Prehabilitation
-
Stanford UniversityCompletedSurgery | Thoracic Diseases | Gastrointestinal Disease | Preoperative Care | Gynecologic Disease | Immune System and Related Disorders | Urological DiseaseUnited States
-
Istituto Ortopedico GaleazziMinistry of Health, ItalyRecruiting
-
Mount Sinai Hospital, CanadaUniversity Health Network, TorontoUnknownPhysical Activity | Surgery | Gastrointestinal Cancer | PrehabilitationCanada
-
ADIR AssociationEuropean Union; French-Speaking Association of Supportive Care in Cancer (AFSOS) and other collaboratorsRecruiting
-
FlevoziekenhuisActive, not recruitingExercise | Physical Fitness | Bariatric Surgery | Prehabilitation | Obesity and Overweight | Six Minute Walk TestNetherlands
-
Peking Union Medical College HospitalNot yet recruitingLung Cancer | Prehabilitation
-
Belfast Health and Social Care TrustQueen's University, BelfastRecruitingLiver TransplantUnited Kingdom
-
University Health Network, TorontoRecruiting
-
Nova Scotia Health AuthorityDalhousie UniversityRecruiting
-
University Hospital, ToulouseRecruitingAbdominal Aortic AneurysmFrance