A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
NCT ID: NCT01586741
Last Updated: 2020-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2009-12-31
2012-12-31
Brief Summary
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The study hypothesis:
Which surgical approach provides the safest and best long term results for patients with abdominal wall diastasis either the insertion of net alternative with a double row suture or exercise alone?
Detailed Description
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All patients examined with a CT scan before randomization and then a Biodex measurement of abdominal muscle strength.
All patients must also complete the SF-36 (scientifically tested instruments to measure self-reported physical and mental health) and VHPQ (ventral hernia Pain Questionnaire).
Two-thirds of patients receive surgery and followed up with a 3 month and 1-year control.At 1 year of control, all go through a CT scan and a Biodex measurement of muscle strength.
The control group followed up after one and half months and 3 months. In the surgery group, patients may not know what reconstruction they received before the final assessment after 1 year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polypropylene mesh
Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.
Quill suture application for repair or polypropylene mesh
The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
quill suture
Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.
Quill suture application for repair or polypropylene mesh
The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
conservative treatment
Regular abdominal exercises workout for three months for 30 patients.
No interventions assigned to this group
Interventions
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Quill suture application for repair or polypropylene mesh
The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Discomfort or tenderness in the abdominal wall
3. Desire for abdominal wall reconstruction
4. Women have undergone at least one birth
5. Smoking cessation 1 month pre-and 3 months post-operatively
Exclusion Criteria
2. Ongoing pregnancy
3. Ongoing breastfeeding
4. Current immunosuppressive therapy
18 Years
65 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Peter Emanuelsson
MD, consultant in plastic surgery
Principal Investigators
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Ulf S Gunnarsson, professor
Role: STUDY_DIRECTOR
Karolinska Institutet
Locations
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Clintec, Karolinska Institutet
Stockholm, , Sweden
Countries
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References
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Emanuelsson P, Gunnarsson U, Strigard K, Stark B. Early complications, pain, and quality of life after reconstructive surgery for abdominal rectus muscle diastasis: a 3-month follow-up. J Plast Reconstr Aesthet Surg. 2014 Aug;67(8):1082-8. doi: 10.1016/j.bjps.2014.04.015. Epub 2014 May 2.
Other Identifiers
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2009/227-31/3/PE/96
Identifier Type: -
Identifier Source: org_study_id