Effect of Postoperative Girdle Following Abdominal Surgery on Pulmonary Function, Mobilisation and Postoperative Pain
Recruitment status was: Recruiting
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.
Procedure: No girdle
|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|
- 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.
- postoperative pain [ Time Frame: 20120630 ] [ Designated as safety issue: No ]pain meassured with VAS scale and amount of medication
|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)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01517217
|Karolinska University Hospital|
|Stockholm, Sweden, 14146|
|Principal Investigator:||Karin Strigård, ass prof||Karolinska Institutet|
|Study Chair:||Leonard Clay, Dr||Karolinska Institutet|
|Study Director:||Ulf Gunnarsson, Prof||Karolinska Institutet|