Pain, PostoperativeNCT01517217
Effect of Postoperative Girdle Following Abdominal Surgery on Pulmonary Function, Mobilisation and Postoperative Pain
A study testing No girdle and Girdle in people with Pain, Postoperative and Respiratory Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Respiratory Depression
- What is being tested?
- No girdle and Girdle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia
- Not possible to understand instructions
- Children (<18 years of age)
- Not involved in other studies during the project
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 14146
Leonard Clay, Dr, +46858580000, leonard.clay@karolinska.se
karin strigård, ass prof, +46858580000, karin.strigard@ki.se
About this study
Official title: Randomised Trial Evaluating the Effect of Postoperative Girdle Following Major Abdominal Surgery
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.
Read more
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.
Read the detailed description
Presently, there is a significant lack of knowledge in everyday surgical practice concerning treatment for incisional hernias and treatment with a corset before and after surgery or as a means of conservative treatment. For many years, corsets have been used in surgical departments without evidence to support this practice.
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
- Physiological parameters
- Measured with spirometry, Vital capacity (VC), Forced Expiratory Volume (FEV), Peak Expiratory Flow (PEF) and with coughPEF
- 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
- Pain, Postoperative, Respiratory Depression
- Being tested
- No girdle, Girdle
- Keywords
- girdle, laparotomy, pulmonary function, postoperative pain, mobilisation
- Medical subject headings
- Pain, Postoperative, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No girdleProcedure or surgery
No girdle is used for the first five postoperative days
GirdleProcedure or surgery
Girdle the first five postoperative days
| Study group | Role | What they receive |
|---|---|---|
| No girdle postoperative | Other | 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. Receives: Procedure: No girdle |
| Girdle postoperative | Other | 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. Receives: Procedure: Girdle |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function
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.
Measured: 20120630
Secondary outcomes (1)
postoperative pain
pain meassured with VAS scale and amount of medication
Measured: 20120630
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startApr 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Strigard, Karolinska Institutet
- Investigators
- Karin Strigård, ass prof, Principal investigator, Karolinska InstitutetLeonard Clay, Dr, Study chair, Karolinska InstitutetUlf Gunnarsson, Prof, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517217
- Sponsor's protocol ID
- 20110201KI
- Status last verified
- Jan 2012
- First submitted
- 9 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24468797
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Evaluating the Effect of Postoperative Girdle Following Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01517217
- Acronym / sponsor ID
- 20110201KI
- Conditions
- Pain, Postoperative, Respiratory Depression
- Keywords
- girdle, laparotomy, pulmonary function, postoperative pain, mobilisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Presently, there is a significant lack of knowledge in everyday surgical practice concerning treatment for incisional hernias and treatment with a corset before and after surgery or as a means of conservative treatment. For many years, corsets have been used in surgical departments without evidence to support this practice.
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
- Physiological parameters
- Measured with spirometry, Vital capacity (VC), Forced Expiratory Volume (FEV), Peak Expiratory Flow (PEF) and with coughPEF
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No girdle postoperative | Other | Procedure: No girdlepatients 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. |
| Girdle postoperative | Other | Procedure: Girdlepatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Dementia
- Not possible to understand instructions
- Children (<18 years of age)
- Not involved in other studies during the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No girdleNo girdle is used for the first five postoperative days | Procedure or surgery | No girdle postoperative |
| GirdleGirdle the first five postoperative days | Procedure or surgery | Girdle postoperative |
Primary outcome
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.
1 secondary outcome
postoperative pain
Time frame: 20120630
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
- Derived from this study: PubMed 24468797Clay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Strigård, ass prof principal investigator
Karolinska Institutet
Leonard Clay, Dr study chair
Karolinska Institutet
Ulf Gunnarsson, Prof study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No girdle and Girdle in people with Pain, Postoperative and Respiratory Depression, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact karin strigård, ass prof (+46858580000, karin.strigard@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function (time frame: 20120630). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01517217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2012.