NCT02352688

Brief Summary

This study evaluates the effects of enhanced geriatric input on elderly patients undergoing colorectal cancer surgery. Half of the participants will received additional pre, peri and post-operative care from the geriatric team, while the other half will receive standard surgical care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2015

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

First Submitted

Initial submission to the registry

January 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

January 19, 2015

Last Update Submit

July 18, 2017

Conditions

Colorectal Cancer

Keywords

elderlyenhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

  • Length of postoperative hospital stay

    up to 90 days

Secondary Outcomes (2)

  • 30-day morbidity

    30 day from time of surgery

  • 30-day mortality

    30 day from time of surgery

Study Arms (2)

Enhanced Colorectal Geriatric Care

ACTIVE COMPARATOR

Multidisciplinary team involving in the elderly colorectal cancer patients' pre-, peri- and postoperative care.

Procedure: Enhanced Colorectal Geriatric Care

Standard Surgical Care

NO INTERVENTION

Standard care given to elderly patients undergoing colorectal cancer resection.

Interventions

Enhanced Colorectal Geriatric CarePROCEDURE
Enhanced Colorectal Geriatric Care

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Consecutive colorectal cancer patients (aged 70 and over) undergoing elective colorectal cancer surgery at the Prince of Wales Hospital, Shatin, Hong Kong
  • American Society of Anaesthesiologists fitness score of I, II or III

You may not qualify if:

  • Colorectal cancer patients aged 69 or under undergoing colorectal surgery
  • Patients undergoing emergency colorectal cancer resection
  • Patients with benign pathology
  • Patients with evidence of locally advanced or metastatic spread of their primary disease
  • Patient who are unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Tony Mak, MD

    Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Colorectal Surgery

Study Record Dates

First Submitted

January 19, 2015

First Posted

February 2, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

HK(1)