NCT01609361

Brief Summary

Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable colorectal-cancer

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

April 20, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

April 20, 2012

Last Update Submit

August 18, 2016

Conditions

Colorectal Cancer

Keywords

Rehabilitation programFast track surgeryLaparoscopic colorectal resectionColorectal cancerMorbidity

Outcome Measures

Primary Outcomes (1)

  • Post operative morbidity at 30 days according to DINDO CLAVIEN classification

    Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV)

    30 days

Secondary Outcomes (6)

  • Mortality according to DINDO CLAVIEN classification

    up to 30 days

  • Hospital stay and readmissions

    up to first month

  • Intravenous perfusion stay

    participants will be followed until the end of hospitalization an expected average of 2 weeks

  • Global (SF36) quality of life

    Preoperative and at 1, 3, 6 months

  • Specific (GIQLI) quality of life

    Preoperative and at 1, 3, 6 months

  • +1 more secondary outcomes

Study Arms (2)

1: Standard surgery + Standard care

NO INTERVENTION

standard surgery and Standard care after surgery

2: Laparoscopy + Rehabilitation program

OTHER

Laparoscopic colorectal surgery with rehabilitation program

Other: Rehabilitation program

Interventions

Rehabilitation programOTHER

Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)

2: Laparoscopy + Rehabilitation program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years old
  • Colorectal cancer
  • Inform and consent form signed
  • Patient has valid health insurance/coverage
  • Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities)
  • Patients with laparoscopic resection for colorectal cancer including abdominoperineal resection
  • Tobacco and alcohol weaning

You may not qualify if:

  • MBI \< 18kg/m2
  • severe malnutrition
  • Metastatic colorectal cancer
  • Buzby Index \<83
  • Combined surgery (hepatic resection or segmental resection of small intestine)
  • Urgent surgery
  • Pregnancy or maternal breastfeeding
  • Body mass index (BMI)\> 30 kg/m2
  • Abdominoperineal resection
  • Subtotal colectomy
  • Total proctocolectomy
  • Cons to Naropin Xylocaine, droperidol, ketamine
  • Patient with a history of peptic ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de chirurgie Colorectale / Hôpital Beaujon

Clichy, 92110, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

June 1, 2012

Study Start

November 1, 2012

Primary Completion

February 1, 2016

Study Completion

July 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

FR(1)