Rehabilitation Following Laparoscopic Colonic Surgery

August 7, 2012 updated by: Martin Bach Jensen, Aarhus University Hospital

Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herning, Denmark, 7400
        • Department of Surgery, Herning Hospital
      • Randers, Denmark, 8910
        • Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue
Time Frame: Preoperative to postoperative day 10
Preoperative to postoperative day 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscular strength
Time Frame: From preoperatively to postoperative day 10 and 30
From preoperatively to postoperative day 10 and 30
Change in work capacity (pulse rate)
Time Frame: From pre- to postoperative day 10 and 30
From pre- to postoperative day 10 and 30
Balance (sway)
Time Frame: From preoperatively to postoperative day 10 and 30
From preoperatively to postoperative day 10 and 30
Pain at rest and when moving
Time Frame: From preoperatively to postoperative day 10 and 30
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
From preoperatively to postoperative day 10 and 30
Body weight
Time Frame: From preoperatively to postoperative day 30
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
From preoperatively to postoperative day 10 and 30
Social support
Time Frame: From preoperatively to postoperative day 10 and 30
From preoperatively to postoperative day 10 and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 10, 2009

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimate)

July 13, 2009

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBJ-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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