NCT04762914

Brief Summary

Quality Improvement Project to evaluate how prehabilitation can be incorporated into our colorectal cancer pathway and assess its clinical benefits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

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

September 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

January 22, 2021

Last Update Submit

February 17, 2021

Conditions

Keywords

Prehabilitation

Outcome Measures

Primary Outcomes (2)

  • Length of stay

    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

    All Clavien-Dindo complications

    Follow up over a period of 90 days following operation

Secondary Outcomes (1)

  • Anaerobic threshold

    CPET performed before prehabilitation and after prehabilitation (median of 36 days)

Study Arms (2)

Prehabilitation (PH)

Patients who underwent prehabilitation prior to colorectal cancer resection

Other: Prehabilitation

Non-Prehabilitation (NPH)

Patients who did not undergo prehabilitation prior to colorectal cancer resection

Interventions

Prehabilitation is a multimodal and multidisciplinary person-centred perioperative approach involving supervised exercise training, nutritional education, management of polypharmacy and psychological advice.

Prehabilitation (PH)

Eligibility Criteria

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

Consecutive patients over the age of 18 needing surgery were identified from clinics, endoscopy or weekly multidisciplinary meetings (MDT). Patients who were clinically judged to be frail or had multiple comorbidities were referred for prehabilitation prior to resection. Those that underwent prehabilitation were matched using operation type, age, sex and ASA with patients who did not have prehabilitation prior to resection. Surgery for all patients was carried out within the context of an enhanced recovery programme.

You may qualify if:

  • Adults over the age of 18 who had prehabilitation for colorectal cancer

You may not qualify if:

  • Children
  • Patients who had prehabilitation but not for colorectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medway Hospitals NHS Trust

Gillingham, Kent, ME7 5NY, United Kingdom

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Richard A Dickson-Lowe

    Medway PCT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 21, 2021

Study Start

September 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations