NCT00938210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

2.5 years

First QC Date

July 10, 2009

Last Update Submit

August 7, 2012

Conditions

Colonic CancerPostoperative CareFatigue

Keywords

Colonic surgeryPostoperative careFatiguePhysical functionQuality of life

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Preoperative to postoperative day 10

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Laparoscopic surgery

NO INTERVENTION

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

Interventions

Laparoscopic colonic surgeryPROCEDURE

Laparoscopic removal of colonic cancer

Laparoscopic surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • elective colonic cancer surgery
  • hemicolectomy or sigmoid resection
  • informed consent

You may not qualify if:

  • disseminated cancer
  • contraindications for laparoscopic surgery
  • dementia or serious psychiatric disease
  • diseases or other aspects that prohibit participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery, Herning Hospital

Herning, 7400, Denmark

Location

Department of Surgery

Randers, 8910, Denmark

Location

MeSH Terms

Conditions

Colonic NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin B Jensen, MD, Ph.d.

    Research Unit for General Practice in the North Denmark Region, Institute of Public Health, Aarhus University

    PRINCIPAL INVESTIGATOR

  • Søren Laurberg, Professor

    Department of Surgery P, Aarhus University Hosptial

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Institute of Public Health Aarhus

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2011

Study Completion

August 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

DK(2)