Benefit of Rehabilitation Program in Colorectal Surgery

NCT ID: NCT01609361

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1: Standard surgery + Standard care

standard surgery and Standard care after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

2: Laparoscopy + Rehabilitation program

Laparoscopic colorectal surgery with rehabilitation program

Group Type OTHER

Rehabilitation program

Intervention Type OTHER

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

Interventions

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Rehabilitation program

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de chirurgie Colorectale / Hôpital Beaujon

Clichy, , France

Site Status

Countries

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France

Other Identifiers

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IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

P111006

Identifier Type: -

Identifier Source: org_study_id

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