Rehabilitation Following Laparoscopic Colonic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Bach Jensen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00938210
First received: July 10, 2009
Last updated: August 7, 2012
Last verified: August 2012
  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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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
Fatigue
Physical function
Quality of life

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

ClinicalTrials.gov processed this record on August 26, 2014