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Rehabilitation Following Laparoscopic Colonic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938210
First Posted: July 13, 2009
Last Update Posted: August 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Martin Bach Jensen, Aarhus University Hospital
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery

Resource links provided by NLM:


Further study details as provided by Martin Bach Jensen, Aarhus University Hospital:

Primary Outcome Measures:
  • Fatigue [ Time Frame: Preoperative to postoperative day 10 ]

Secondary Outcome Measures:
  • Muscular strength [ Time Frame: From preoperatively to postoperative day 10 and 30 ]
  • Change in work capacity (pulse rate) [ Time Frame: From pre- to postoperative day 10 and 30 ]
  • Balance (sway) [ Time Frame: From preoperatively to postoperative day 10 and 30 ]
  • Pain at rest and when moving [ Time Frame: From preoperatively to postoperative day 10 and 30 ]
  • Quality of life (Short Form 36 - SF-36) [ Time Frame: From preoperatively to postoperative day 10 and 30 ]
  • Body weight [ Time Frame: From preoperatively to postoperative day 30 ]
  • Body composition (fat mass and fat free mass estimated by bio-impedance) [ Time Frame: From preoperatively to postoperative day 10 and 30 ]
  • Social support [ Time Frame: From preoperatively to postoperative day 10 and 30 ]

Enrollment: 50
Study Start Date: May 2009
Study Completion Date: August 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Laparoscopic surgery
Patients undergoing laparoscopic colonic surgery are compared with a historical cohort of patients undergoing similar open colonic surgery (right hemicolectomy and sigmoid resections).
Procedure: Laparoscopic colonic surgery
Laparoscopic removal of colonic cancer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938210


Locations
Denmark
Department of Surgery, Herning Hospital
Herning, Denmark, 7400
Department of Surgery
Randers, Denmark, 8910
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Martin B Jensen, MD, Ph.d. Research Unit for General Practice in the North Denmark Region, Institute of Public Health, Aarhus University
Study Chair: Søren Laurberg, Professor Department of Surgery P, Aarhus University Hosptial
  More Information

Responsible Party: Martin Bach Jensen, Associate Professor, Institute of Public Health Aarhus, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00938210     History of Changes
Other Study ID Numbers: MBJ-1
First Submitted: July 10, 2009
First Posted: July 13, 2009
Last Update Posted: August 8, 2012
Last Verified: August 2012

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

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