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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Karin Strigard, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01517217
First received: January 9, 2012
Last updated: January 20, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Karolinska Institutet:

Primary Outcome Measures:
  • pulmonary function [ Time Frame: 20120630 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Karolinska Institutet

Additional 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
Study First Received: January 9, 2012
Last Updated: January 20, 2012
Health Authority: Sweden: The National Board of Health and Welfare

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

Additional relevant MeSH terms:
Depression
Pain, Postoperative
Respiratory Insufficiency
Behavioral Symptoms
Pain
Pathologic Processes
Postoperative Complications
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014