Rehabilitation Following Laparoscopic Colonic Surgery

Sponsor

Aarhus University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00938210

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Colonic Cancer Postoperative Care Fatigue	Procedure: Laparoscopic colonic surgery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fatigue [Preoperative to postoperative day 10]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Herning Hospital	Herning		Denmark	7400
2	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