NCT01517217

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 25, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

January 9, 2012

Last Update Submit

January 20, 2012

Conditions

Pain, PostoperativeRespiratory Depression

Keywords

girdlelaparotomypulmonary functionpostoperative painmobilisation

Outcome Measures

Primary Outcomes (1)

  • 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.

    20120630

Secondary Outcomes (1)

  • postoperative pain

    20120630

Study Arms (2)

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.

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.

Procedure: Girdle

Interventions

No girdlePROCEDURE

No girdle is used for the first five postoperative days

No girdle postoperative
GirdlePROCEDURE

Girdle the first five postoperative days

Girdle postoperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Dementia
  • Not possible to understand instructions
  • Children (\<18 years of age)
  • Not involved in other studies during the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 14146, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24468797DERIVED

MeSH Terms

Conditions

Pain, PostoperativeRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Karin Strigård, ass prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Leonard Clay, Dr

    Karolinska Institutet

    STUDY CHAIR

  • Ulf Gunnarsson, Prof

    Karolinska Institutet

    STUDY DIRECTOR

Central Study Contacts

karin strigård, ass prof

CONTACT

+46858580000karin.strigard@ki.se

ulf gunnarsson, prof

CONTACT

+46858580000ulf.gunnarsson@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass. professor

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 25, 2012

Study Start

April 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 25, 2012

Record last verified: 2012-01

Locations

SE(1)