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Effect of Postoperative Girdle Following Abdominal Surgery on Pulmonary Function, Mobilisation and Postoperative Pain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Karin Strigard, Karolinska Institutet.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517217
First Posted: January 25, 2012
Last Update Posted: January 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karin Strigard, Karolinska Institutet
  Purpose

There is a considerable lack of knowledge in everyday surgical practice concerning treatment with a corset after laparotomy, in surgery for incisional hernia or as conservative treatment.

The aims are to elucidate effects of corset treatment on patient experience and pain, physiology and abdominal wall strength.

Effects of corset treatment after laparotomy will be studied in a randomised trial with the hypothesis that postoperative corset-use improves respiratory physiology and reduce pain. The primary end-point is PeakCoughFlow change, secondary end-points are vital capacity, residual volumes and patient perception as measured by the ventral hernia pain questionnaire (VHPQ) developed by our group. This study is powered for 50 patients.

Conclusions from the study are of such a nature that they can be immediately transferred to clinical practice.


Condition Intervention
Pain, Postoperative Respiratory Depression Procedure: No girdle Procedure: Girdle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomised Trial Evaluating the Effect of Postoperative Girdle Following Major Abdominal Surgery

Further study details as provided by Karin Strigard, Karolinska Institutet:

Primary Outcome Measures:
  • pulmonary function [ Time Frame: 20120630 ]
    Participans will be followed for the duration of 5 days or the duration of hospital stay, if shorter than 5 days. Spirometry will be assessed the day before surgery and therafter the day after surgery and every day after the end of the study.


Secondary Outcome Measures:
  • postoperative pain [ Time Frame: 20120630 ]
    pain meassured with VAS scale and amount of medication


Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No girdle postoperative
patients undergoing major abdominal surgery will get NO individualized girdle. Functional outcomes as pulmonary function and pain are measured daily. Participants will be followed for the duration of 5 days or the duration of hospital stay, if shorter than 5 days.
Procedure: No girdle
No girdle is used for the first five postoperative days
Girdle postoperative
patients undergoing major abdominal surgery will get an individualized girdle. Functional outcomes as pulmonary function and pain are measured daily. Participants will be followed for the duration of 5 days or the duration of hospital stay, if shorter than 5 days.
Procedure: Girdle
Girdle the first five postoperative days

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The inclusion in the study is done to reflect the normal population on a colorectal surgery ward.

Inclusion Criteria:

  • Patients undergoing laparotomy with a midline incision more than 12 cm
  • Over 18 years of age
  • Planned time at ward less than 10 days
  • Not on oxygen treatment at home

The exclusion criteria are minimized but made to avoid obvious confounding

Exclusion Criteria:

  • Dementia
  • Not possible to understand instructions
  • Children (<18 years of age)
  • Not involved in other studies during the project
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01517217


Contacts
Contact: karin strigård, ass prof +46858580000 karin.strigard@ki.se
Contact: ulf gunnarsson, prof +46858580000 ulf.gunnarsson@ki.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 14146
Contact: Leonard Clay, Dr    +46858580000    leonard.clay@karolinska.se   
Contact: karin strigård, ass prof    +46858580000    karin.strigard@ki.se   
Principal Investigator: karin strigård, ass prof         
Sub-Investigator: Ulf Gunnarsson, professor         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Karin Strigård, ass prof Karolinska Institutet
Study Chair: Leonard Clay, Dr Karolinska Institutet
Study Director: Ulf Gunnarsson, Prof Karolinska Institutet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karin Strigard, ass. professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01517217     History of Changes
Other Study ID Numbers: 20110201KI
First Submitted: January 9, 2012
First Posted: January 25, 2012
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Karin Strigard, Karolinska Institutet:
girdle
laparotomy
pulmonary function
postoperative pain
mobilisation

Additional relevant MeSH terms:
Pain, Postoperative
Respiratory Insufficiency
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases