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Rehabilitation Following Laparoscopic Colonic Surgery

Primary Purpose

Colonic Cancer, Postoperative Care, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Laparoscopic colonic surgery
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Cancer focused on measuring Colonic surgery, Postoperative care, Fatigue, Physical function, Quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Surgery, Herning Hospital
  • Department of Surgery

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Laparoscopic surgery

Arm Description

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

Outcomes

Primary Outcome Measures

Fatigue

Secondary Outcome Measures

Muscular strength
Change in work capacity (pulse rate)
Balance (sway)
Pain at rest and when moving
Quality of life (Short Form 36 - SF-36)
Body weight
Body composition (fat mass and fat free mass estimated by bio-impedance)
Social support

Full Information

First Posted
July 10, 2009
Last Updated
August 7, 2012
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00938210
Brief Title
Rehabilitation Following Laparoscopic Colonic Surgery
Official Title
Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Cancer, Postoperative Care, Fatigue
Keywords
Colonic surgery, Postoperative care, Fatigue, Physical function, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic surgery
Arm Type
No Intervention
Arm Description
Patients undergoing laparoscopic colonic surgery are compared with a historical cohort of patients undergoing similar open colonic surgery (right hemicolectomy and sigmoid resections).
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic colonic surgery
Intervention Description
Laparoscopic removal of colonic cancer
Primary Outcome Measure Information:
Title
Fatigue
Time Frame
Preoperative to postoperative day 10
Secondary Outcome Measure Information:
Title
Muscular strength
Time Frame
From preoperatively to postoperative day 10 and 30
Title
Change in work capacity (pulse rate)
Time Frame
From pre- to postoperative day 10 and 30
Title
Balance (sway)
Time Frame
From preoperatively to postoperative day 10 and 30
Title
Pain at rest and when moving
Time Frame
From preoperatively to postoperative day 10 and 30
Title
Quality of life (Short Form 36 - SF-36)
Time Frame
From preoperatively to postoperative day 10 and 30
Title
Body weight
Time Frame
From preoperatively to postoperative day 30
Title
Body composition (fat mass and fat free mass estimated by bio-impedance)
Time Frame
From preoperatively to postoperative day 10 and 30
Title
Social support
Time Frame
From preoperatively to postoperative day 10 and 30

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B Jensen, MD, Ph.d.
Organizational Affiliation
Research Unit for General Practice in the North Denmark Region, Institute of Public Health, Aarhus University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Søren Laurberg, Professor
Organizational Affiliation
Department of Surgery P, Aarhus University Hosptial
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Surgery, Herning Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Department of Surgery
City
Randers
ZIP/Postal Code
8910
Country
Denmark

12. IPD Sharing Statement

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Rehabilitation Following Laparoscopic Colonic Surgery

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