Rehabilitation Following Laparoscopic Colonic Surgery
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|ClinicalTrials.gov Identifier: NCT00938210|
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : August 8, 2012
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|
|Colonic Cancer Postoperative Care Fatigue||Procedure: Laparoscopic colonic surgery|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery|
|Study Start Date :||May 2009|
|Primary Completion Date :||November 2011|
|Study Completion Date :||August 2012|
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
- Fatigue [ Time Frame: Preoperative to postoperative day 10 ]
- Muscular strength [ Time Frame: From preoperatively to postoperative day 10 and 30 ]
- Change in work capacity (pulse rate) [ Time Frame: From pre- to postoperative day 10 and 30 ]
- Balance (sway) [ Time Frame: From preoperatively to postoperative day 10 and 30 ]
- Pain at rest and when moving [ Time Frame: 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 ]
- Body weight [ Time Frame: 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 ]
- Social support [ Time Frame: From preoperatively to postoperative day 10 and 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938210
|Department of Surgery, Herning Hospital|
|Herning, Denmark, 7400|
|Department of Surgery|
|Randers, Denmark, 8910|
|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|