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Rehabilitation Following Laparoscopic Colonic Surgery
This study is currently recruiting participants.
Verified by Aarhus University Hospital, July 2009
First Received: July 10, 2009   No Changes Posted
Sponsored by: Aarhus University Hospital
Information provided by: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00938210
  Purpose

The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery.

Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery.

This study examines how fatigue, quality of life, physical function, and body composition changes following laparoscopic colonic surgery. Patients are examined preoperatively and postoperative day 10 and 30.


Condition Intervention
Colonic Cancer
Postoperative Care
Fatigue
Procedure: Laparoscopic colonic surgery

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Fatigue [ Time Frame: Preoperative to postoperative day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscular strength [ Time Frame: From preoperatively to postoperative day 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Laparoscopic colonic surgery
    Laparoscopic removal of colonic cancer
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective colonic cancer surgery
  • hemicolectomy or sigmoid resection
  • informed consent

Exclusion Criteria:

  • disseminated cancer
  • contraindications for laparoscopic surgery
  • dementia or serious psychiatric disease
  • diseases or other aspects that prohibit participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938210

Contacts
Contact: Martin B Jensen, MD, Ph.d. +45 98464519 mbj@dadlnet.dk

Locations
Denmark
Department of Surgery P, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Martin B Jensen, MD, Ph.D            
Department of Surgery, Herning Hospital Not yet recruiting
Herning, Denmark, 7400
Contact: Mogens Rørbæk, MD     +45 99272727     hecmr@ringamt.dk    
Principal Investigator: Mogens Rørbæk, MD            
Department of Surgery Not yet recruiting
Randers, Denmark, 8910
Contact: Thorbjørn Sommer, MD, Ph.d.     +45 89102000     thorbjorn.sommer@randers.rm.dk    
Principal Investigator: Thorbjørn Sommer, MD, Ph.d.            
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Martin B Jensen, MD, Ph.d. Department of Surgery P, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Surgical Department P, Aarhus University Hospital ( Martin Bach Jensen, MD. Ph.d. )
Study ID Numbers: MBJ-1
Study First Received: July 10, 2009
Last Updated: July 10, 2009
ClinicalTrials.gov Identifier: NCT00938210     History of Changes
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Colonic surgery
Postoperative care
Fatigue
Physical function
Quality of life

Study placed in the following topic categories:
Signs and Symptoms
Digestive System Diseases
Digestive System Neoplasms
Fatigue
Gastrointestinal Diseases
Colonic Diseases
Quality of Life
Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Fatigue
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Neoplasms
Signs and Symptoms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009