Effect of Postoperative Girdle Following Abdominal Surgery on Pulmonary Function, Mobilisation and Postoperative Pain
|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.|
|ClinicalTrials.gov Identifier: NCT01517217|
Recruitment Status : Unknown
Verified January 2012 by Karin Strigard, Karolinska Institutet.
Recruitment status was: Recruiting
First Posted : January 25, 2012
Last Update Posted : January 25, 2012
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 or disease||Intervention/treatment||Phase|
|Pain, Postoperative Respiratory Depression||Procedure: No girdle Procedure: Girdle||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
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
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.
Girdle the first five postoperative days
- 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.
- postoperative pain [ Time Frame: 20120630 ]pain meassured with VAS scale and amount of medication
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
|Contact: karin strigård, ass email@example.com|
|Contact: ulf gunnarsson, firstname.lastname@example.org|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 14146|
|Contact: Leonard Clay, Dr +46858580000 email@example.com|
|Contact: karin strigård, ass prof +46858580000 firstname.lastname@example.org|
|Principal Investigator: karin strigård, ass prof|
|Sub-Investigator: Ulf Gunnarsson, professor|
|Principal Investigator:||Karin Strigård, ass prof||Karolinska Institutet|
|Study Chair:||Leonard Clay, Dr||Karolinska Institutet|
|Study Director:||Ulf Gunnarsson, Prof||Karolinska Institutet|