CClinicalTrials.gg
CompletedNCT00938210Updated Aug 8, 2012

Rehabilitation Following Laparoscopic Colonic Surgery

An interventional study of Laparoscopic colonic surgery in Colonic Cancer, Postoperative Care and Fatigue, sponsored by Aarhus University Hospital. Completed at 2 sites in Denmark. Per ClinicalTrials.gov, last updated 2012-08-08.

Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Colonic Cancer
  • Postoperative Care
  • Fatigue

Keywords

  • Colonic surgery
  • Postoperative care
  • Fatigue
  • Physical function
  • Quality of life
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • disseminated cancer
  • contraindications for laparoscopic surgery
  • dementia or serious psychiatric disease
  • diseases or other aspects that prohibit participation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureLaparoscopic colonic surgery

    Laparoscopic removal of colonic cancer

06

What researchers measure

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

07

Study locations

2 sites
  • Department of Surgery, Herning Hospital
    Herning, 7400, Denmark
  • Department of Surgery
    Randers, 8910, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00938210
Lead sponsor
Aarhus University Hospital
Responsible party
Martin Bach Jensen (Associate Professor, Institute of Public Health Aarhus, Aarhus University Hospital) — Principal investigator
First posted
Jul 13, 2009
Start date
May 2009
Primary completion
Nov 2011
Completion
Aug 2012
Last update
Aug 8, 2012

Study contacts

Martin B Jensen, MD, Ph.d.
principal investigator · Research Unit for General Practice in the North Denmark Region, Institute of Public Health, Aarhus University
Søren Laurberg, Professor
study chair · Department of Surgery P, Aarhus University Hosptial

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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