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This is a three armed prospective randomized trial that will compare two different surgical techniques for reconstruction of the abdominal wall diastasis with a conservative treatment procedure.
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?
The conservative control group will receive a special training program for abdominal muscle training for 3 months,and all groups wearing girdle for 3 months.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polypropylene mesh | Active Comparator | Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients. |
|
| quill suture | Active Comparator | Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients. |
|
| conservative treatment | No Intervention | Regular abdominal exercises workout for three months for 30 patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quill suture application for repair or polypropylene mesh | Procedure | The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. | All patients go through a CT scan and clinical examination one year after surgery | follow-up 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Indicated in Case Report Formulary During the First 12 Months | adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection | follow-up 1 year after surgery |
| Pain Post Operatively Measured by the VHPQ Questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulf S Gunnarsson, professor | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clintec, Karolinska Institutet | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24880577 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Conservative Treatment | Regular abdominal exercises workout for three months for 30 patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. | All patients go through a CT scan and clinical examination one year after surgery | Posted | Count of Participants | Participants | follow-up 1 year after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| D. Peter Emanuelsson | Karolinska University Hospital | +46851770000 | peter.emanuelsson@sll.se |
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| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D010149 | Pain, Postoperative |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014945 | Wound Healing |
| ID | Term |
|---|---|
| D012038 | Regeneration |
| D001686 | Biological Phenomena |
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|
The validity and reliability of the VHPQ make it a useful tool in assessing postoperative pain and patient satisfaction. PMID: 22446989 PubMed - as supplied by publisher |
| follow-up 1 year after surgery |
| 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 |
| BG002 | Conservative Treatment | Regular abdominal exercises workout for three months for 30 patients. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Conservative Treatment | Regular abdominal exercises workout for three months for 30 patients. |
|
|
| Secondary | Adverse Event Indicated in Case Report Formulary During the First 12 Months | adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection | Not Posted | Nov 2020 | follow-up 1 year after surgery | Participants |
| Secondary | Pain Post Operatively Measured by the VHPQ Questionnaires | The validity and reliability of the VHPQ make it a useful tool in assessing postoperative pain and patient satisfaction. PMID: 22446989 PubMed - as supplied by publisher | Not Posted | follow-up 1 year after surgery | Participants |
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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 | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | Conservative Treatment | Regular abdominal exercises workout for three months for 30 patients. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|