An interventional study of Quill suture application for repair or polypropylene mesh in Abdominal Hernias and Other Abdominal Wall Conditions, Post-operative Pain and Recurrence, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-23.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's enrollment of 96 is close to the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.
Procedure: Quill suture application for repair or polypropylene mesh
Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.
Procedure: Quill suture application for repair or polypropylene mesh
Regular abdominal exercises workout for three months for 30 patients.
The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
Also known as: Quill suture, And Soft mesh Polypropylene mesh
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
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
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
| Milestone | Quill Suture | Polypropylene Mesh | Conservative Treatment |
|---|---|---|---|
| Started | 28 | 29 | 32 |
| Completed | 27 | 29 | 30 |
| Not completed | 1 | 0 | 2 |
All patients go through a CT scan and clinical examination one year after surgery
| Participants | Polypropylene Mesh | Quill Suture | Conservative Treatment |
|---|---|---|---|
| Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. | 2 | 3 | 26 |
adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quill Suture | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Polypropylene Mesh | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Conservative Treatment | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Polypropylene Mesh | Quill Suture | Conservative Treatment | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 28 | 31 | 88 |
| >=65 years | 0 | 0 | 1 | 1 |
| Age, Continuous(years) | Polypropylene Mesh | Quill Suture | Conservative Treatment | Total |
|---|---|---|---|---|
| Median | 42 (27 to 62) | 39.6 (24 to 61) | 44.2 (28.9 to 66.9) | 41.9 (24 to 66.9) |
| Sex: Female, Male(Participants) | Polypropylene Mesh | Quill Suture | Conservative Treatment | Total |
|---|---|---|---|---|
| Female | 28 | 27 | 32 | 87 |
| Male | 1 | 1 | 0 | 2 |
| Race and Ethnicity Not Collected(Participants) | Polypropylene Mesh | Quill Suture | Conservative Treatment | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Polypropylene Mesh | Quill Suture | Conservative Treatment | Total |
|---|---|---|---|---|
| Sweden | 29 | 28 | 32 | 89 |
Ran from Dec 2009 to primary completion in Nov 2011, 23 months.
Results were first posted in Dec 2020, 9 years 1 month after primary completion.
Of 31 interventional studies with no phase under Hernia, Abdominal, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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