Rehabilitation Following Laparoscopic Colonic Surgery

Not Applicable

Completed

• Conditions: Colonic Cancer; Postoperative Care; Fatigue
• Interventions: Procedure: Laparoscopic colonic surgery

• Registration Number: NCT00938210
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2011-11
• Status Verified: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic surgery	Laparoscopic colonic surgery	Patients undergoing laparoscopic colonic surgery are compared with a historical cohort of patients undergoing similar open colonic surgery (right hemicolectomy and sigmoid resections).

Primary Outcome Measures

Name	Time	Method
Fatigue	Preoperative to postoperative day 10

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Department of Surgery, Herning Hospital; 🇩🇰 Herning, Denmark

Department of Surgery; 🇩🇰 Randers, Denmark