Abdominal Hernias and Other Abdominal Wall Conditions, Post-operative Pain, Recurrence
Conditions
Brief summary
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?
Detailed description
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.
Interventions
PROCEDUREQuill 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
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Abdominal wall diastasis\> 3 cm 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
1. \<18 years old 2. Ongoing pregnancy 3. Ongoing breastfeeding 4. Current immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. | follow-up 1 year after surgery | All patients go through a CT scan and clinical examination one year after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Indicated in Case Report Formulary During the First 12 Months | follow-up 1 year after surgery | adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection |
| Pain Post Operatively Measured by the VHPQ Questionnaires | follow-up 1 year after surgery | 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 |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| 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 | 28 |
| Conservative Treatment Regular abdominal exercises workout for three months for 30 patients. | 32 |
| Total | 89 |
Baseline characteristics
| Characteristic | Total | Polypropylene Mesh | Quill Suture | Conservative Treatment |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants | 29 Participants | 28 Participants | 31 Participants |
| Age, Continuous | 41.9 years | 42 years | 39.6 years | 44.2 years |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment Sweden | 89 participants | 29 participants | 28 participants | 32 participants |
| Sex: Female, Male Female | 87 Participants | 28 Participants | 27 Participants | 32 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 27 | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 27 | 0 / 29 | 0 / 30 |
Outcome results
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
Time frame: follow-up 1 year after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polypropylene Mesh | Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. | 2 Participants |
| Quill Suture | Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. | 3 Participants |
| Conservative Treatment | Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. | 26 Participants |
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
Time frame: follow-up 1 year after surgery
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
Time frame: follow-up 1 year after surgery