Effect of Postoperative Girdle Following Abdominal Surgery on Pulmonary Function, Mobilisation and Postoperative Pain
This study is currently recruiting participants.
Verified January 2012 by Karolinska Institutet
Sponsor:
Karolinska Institutet
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Resource links provided by NLM:
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
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
| 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 Depressive Disorder Pain, Postoperative Respiratory Insufficiency Behavioral Symptoms Mood Disorders Mental Disorders |
Postoperative Complications Pathologic Processes Pain Signs and Symptoms Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013