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Completed

NCT Number: NCT01609361

Benefit of Rehabilitation Program in Colorectal Surgery

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de chirurgie Colorectale / Hôpital Beaujon

Clichy, 92110, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

(arm : Laparoscopy + Rehabilitation program):

  • 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

Treatment and study plan

Rehabilitation program

Other

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

Primary outcomes

  1. Post operative morbidity at 30 days according to DINDO CLAVIEN classification

    Time frame: 30 days

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

Secondary outcomes

  1. Mortality according to DINDO CLAVIEN classification

    Time frame: up to 30 days

    Mortality according to DINDO CLAVIEN classification (grade V)

  2. Hospital stay and readmissions

    Time frame: up to first month

    Initial hospital stay and possible unscheduled readmissions

  3. Intravenous perfusion stay

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

  4. Global (SF36) quality of life

    Time frame: Preoperative and at 1, 3, 6 months

    Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months

  5. Specific (GIQLI) quality of life

    Time frame: Preoperative and at 1, 3, 6 months

    Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months

  6. Duration of laxation (gas and stool)

    Time frame: up to hospital discharge

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

Acronym: REHAB

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2012
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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