Effect of Postoperative Girdle Following Abdominal Surgery on Pulmonary Function, Mobilisation and Postoperative Pain
NCT ID: NCT01517217
Last Updated: 2012-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2011-04-30
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery
NCT04912557
Effect of TAP Block on Ventilatory Function Following Abdominal Surgery
NCT01719796
Development and Validation of a Risk Prediction Model for Postoperative Visceral Pain in Abdominal Surgery Patients
NCT07048782
Continuous Paravertebral Block on Postoperative Pain After Hepatectomy
NCT01691937
Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study
NCT05244655
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Corsets are expensive and require good patient compliance. Some arguments for the use of corsets are reduced pain and tension in the abdominal wall and prevention of the development and recurrence of incisional hernias, as well as their use as a truss in cases where conservative treatment is decided on.
The aim of this project is thus to ameliorate the lack of knowledge surrounding corset use.
More specifically, the aims of the project are to clarify the effects of corset use on
1. Physiological parameters
* Measured with spirometry, Vital capacity (VC), Forced Expiratory Volume (FEV), Peak Expiratory Flow (PEF) and with coughPEF
2. Patient comfort, pain and self-perceived experience
* Measured with VAS scale for pain. VHPQ (ventral hernia pain questionary) for pain. Recording of medication. Grade of mobilisation.
Corset treatment has been thought to affect cardiovascular and respiratory function as well as intra abdominal pressure both in positive and negative directions. There are no scientific publications that specifically describe and evaluate these effects. One reason for this could be that the assessment of such parameters is difficult and time-consuming in clinical practice, for instance spirometry. Less complicated alternatives e.g. Peak Expiratory Flow rate (PEF) has been considered too imprecise. However, recently, a simpler and more efficient instrument has been developed for measuring lung function, the Peak Cough Flow (PCF). It has been validated for use in pulmonary function testing in patients with neuromuscular disorders, where it is used to predict the risk of an inadequate coughing response and mucus clearance. Moreover, portable digital spirometers have been developed that can be easily used in an ambulatory setting. Postoperatively, similar problems may arise with a reduction in vital capacity. It is therefore important to investigate the effects of corsets on lung function.
Many patients that undergo laparotomy have an indwelling urinary catheter during the first postoperative days, often as a result of epidural anaesthesia but also for monitoring of fluid balance. A urinary catheter also allows for the measurement of the intra abdominal pressure, which, together with the measurement of systemic blood pressure, gives a good estimate of physiological parameters which can be used to compare different treatment groups.
A randomised controlled study concerning the postoperative use of corsets after laparotomy.
Hypothesis: Postoperative corset-use improves respiratory physiology as measured using the PCF without impairing other spirometric parameters. Corsets also reduce pain and discomfort after surgery.
Consecutive patients undergoing laparotomy at the Centre for Gastrointestinal surgery at the Karolinska University Hospital are asked whether they would accept to participate in a randomised study where one arm receives a corset for five days postoperatively and the other does not receive a corset after laparotomy. The primary end-point is PCF change, secondary end-points are vital capacity, residual volumes and patient perception as measured by the VHPQ. A GCP-trained research nurse with extensive experience will be in charge of monitoring and collection of data. PCF will be measured using a portable PCF apparatus (Peak flow meter, HS Clerment Clarke International) whereas other spirometric parameters are measured using a portable computer-assisted vitalograph (IM-Medico ML 2525). Pain and the functional status of the patients will be measured using the VHPQ as described above and the EuroQoL.
Based on previous measurements, a normal PCF without corset is assumed to be around 360ml/min. Assuming that the standard deviation is 40ml/min and that the corset improves performance by 10%, 21 patients will be required in each group (42 in total) at 95% significance level and power of 80%. In order to compensate for patient drop-out, we plan to include 50 patients. If intra abdominal pressure rises above 28cmH2O or if there are signs of wound infection, the corset will be removed. The wound will be photographed on day five in all patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Girdle
Girdle the first five postoperative days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No girdle
No girdle is used for the first five postoperative days
Girdle
Girdle the first five postoperative days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Over 18 years of age
* Planned time at ward less than 10 days
* Not on oxygen treatment at home
Exclusion Criteria
* Not possible to understand instructions
* Children (\<18 years of age)
* Not involved in other studies during the project
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karolinska Institutet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karin Strigard
ass. professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karin Strigård, ass prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Leonard Clay, Dr
Role: STUDY_CHAIR
Karolinska Institutet
Ulf Gunnarsson, Prof
Role: STUDY_DIRECTOR
Karolinska Institutet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Karolinska University Hospital
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Clay L, Gunnarsson U, Franklin KA, Strigard K. Effect of an elastic girdle on lung function, intra-abdominal pressure, and pain after midline laparotomy: a randomized controlled trial. Int J Colorectal Dis. 2014 Jun;29(6):715-21. doi: 10.1007/s00384-014-1834-x. Epub 2014 Jan 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20110201KI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.