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OpenTrials
Completed

NCT Number: NCT00938210

Rehabilitation 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.

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Key information

Conditions

Colonic Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Fatigue Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Postoperative Care Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Herning Hospital, Herning, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic colonic surgery

Procedure

Laparoscopic removal of colonic cancer

Primary outcomes

  1. Fatigue

    Time frame: Preoperative to postoperative day 10

Secondary outcomes

  1. Muscular strength

    Time frame: From preoperatively to postoperative day 10 and 30

  2. Change in work capacity (pulse rate)

    Time frame: From pre- to postoperative day 10 and 30

  3. Balance (sway)

    Time frame: From preoperatively to postoperative day 10 and 30

  4. Pain at rest and when moving

    Time frame: From preoperatively to postoperative day 10 and 30

  5. Quality of life (Short Form 36 - SF-36)

    Time frame: From preoperatively to postoperative day 10 and 30

  6. Body weight

    Time frame: From preoperatively to postoperative day 30

  7. Body composition (fat mass and fat free mass estimated by bio-impedance)

    Time frame: From preoperatively to postoperative day 10 and 30

  8. Social support

    Time frame: From preoperatively to postoperative day 10 and 30

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 13, 2009
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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