Rehabilitation Following Laparoscopic Colonic Surgery

Fatigue Clinical Trial

Official title:

Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938210
• Other study ID #: MBJ-1
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: August 7, 2012
• Start date: May 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Cancer
• Fatigue
• Postoperative Care

Intervention

Procedure:
• Laparoscopic colonic surgery
Laparoscopic removal of colonic cancer

Locations

Country	Name	City	State
Denmark	Department of Surgery, Herning Hospital	Herning
Denmark	Department of Surgery	Randers

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue		Preoperative to postoperative day 10	No
Secondary	Muscular strength		From preoperatively to postoperative day 10 and 30	No
Secondary	Change in work capacity (pulse rate)		From pre- to postoperative day 10 and 30	No
Secondary	Balance (sway)		From preoperatively to postoperative day 10 and 30	No
Secondary	Pain at rest and when moving		From preoperatively to postoperative day 10 and 30	No
Secondary	Quality of life (Short Form 36 - SF-36)		From preoperatively to postoperative day 10 and 30	No
Secondary	Body weight		From preoperatively to postoperative day 30	No
Secondary	Body composition (fat mass and fat free mass estimated by bio-impedance)		From preoperatively to postoperative day 10 and 30	No
Secondary	Social support		From preoperatively to postoperative day 10 and 30	No