Rehabilitation Following Laparoscopic Colonic Surgery

This study has been completed.
Information provided by (Responsible Party):
Martin Bach Jensen, Aarhus University Hospital Identifier:
First received: July 10, 2009
Last updated: August 7, 2012
Last verified: August 2012

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
Procedure: Laparoscopic colonic surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 and 30 ] [ Designated as safety issue: No ]
  • Change in work capacity (pulse rate) [ Time Frame: From pre- to postoperative day 10 and 30 ] [ Designated as safety issue: No ]
  • Balance (sway) [ Time Frame: From preoperatively to postoperative day 10 and 30 ] [ Designated as safety issue: No ]
  • Pain at rest and when moving [ Time Frame: From preoperatively to postoperative day 10 and 30 ] [ Designated as safety issue: No ]
  • Quality of life (Short Form 36 - SF-36) [ Time Frame: From preoperatively to postoperative day 10 and 30 ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: From preoperatively to postoperative day 30 ] [ Designated as safety issue: No ]
  • Body composition (fat mass and fat free mass estimated by bio-impedance) [ Time Frame: From preoperatively to postoperative day 10 and 30 ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: From preoperatively to postoperative day 10 and 30 ] [ Designated as safety issue: No ]

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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00938210

Department of Surgery, Herning Hospital
Herning, Denmark, 7400
Department of Surgery
Randers, Denmark, 8910
Sponsors and Collaborators
Aarhus University Hospital
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 Identifier: NCT00938210     History of Changes
Other Study ID Numbers: MBJ-1 
Study First Received: July 10, 2009
Last Updated: August 7, 2012
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Signs and Symptoms processed this record on May 22, 2016