Abdominal Hernias and Other Abdominal Wall ConditionsNCT01586741
A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
A study testing Quill suture application for repair or polypropylene mesh in people with Abdominal Hernias and Other Abdominal Wall Conditions and Post-operative Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Hernias and Other Abdominal Wall Conditions, Post-operative Pain, Recurrence
- What is being tested?
- Quill suture application for repair or polypropylene mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominal wall diastasis> 3 cm
- Discomfort or tenderness in the abdominal wall
- Desire for abdominal wall reconstruction
- Women have undergone at least one birth
- Smoking cessation 1 month pre-and 3 months post-operatively
Who cannot join
- <18 years old
- Ongoing pregnancy
- Ongoing breastfeeding
- Current immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
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?
Read the 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.
- Being tested
- Quill suture application for repair or polypropylene mesh
- Medical subject headings
- Hernia, Abdominal, Pain, Postoperative, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quill suture application for repair or polypropylene meshProcedure or surgery
Also called Quill suture, And Soft mesh 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
| Study group | Role | What they receive |
|---|---|---|
| Polypropylene mesh | Active comparator | Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients. Receives: Procedure: Quill suture application for repair or polypropylene mesh |
| quill suture | Active comparator | Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients. Receives: Procedure: Quill suture application for repair or polypropylene mesh |
| conservative treatment | No intervention | Regular abdominal exercises workout for three months for 30 patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: follow-up 1 year after surgery
Secondary outcomes (2)
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
Measured: 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
Measured: follow-up 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startDec 2009
- Primary completionNov 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Hernias and Other Abdominal Wall ConditionsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Emanuelsson, Karolinska Institutet
- Investigators
- Ulf S Gunnarsson, professor, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586741
- Sponsor's protocol ID
- 2009/227-31/3/PE/96
- Status last verified
- Nov 2020
- First submitted
- 21 Nov 2011
- Last updated
- 23 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24880577
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
- ClinicalTrials.gov ID
- NCT01586741
- Acronym / sponsor ID
- 2009/227-31/3/PE/96
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2009 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Posted 23 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polypropylene mesh | Active comparator | Procedure: Quill suture application for repair or polypropylene meshReconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients. |
| quill suture | Active comparator | Procedure: Quill suture application for repair or polypropylene meshReconstruction 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Abdominal wall diastasis> 3 cm
- Discomfort or tenderness in the abdominal wall
- Desire for abdominal wall reconstruction
- Women have undergone at least one birth
- Smoking cessation 1 month pre-and 3 months post-operatively
Key exclusion criteria (4 listed)
- <18 years old
- Ongoing pregnancy
- Ongoing breastfeeding
- Current immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quill suture application for repair or polypropylene meshAlso: Quill suture, And Soft mesh Polypropylene meshThe first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training | Procedure or surgery | Polypropylene mesh, quill suture |
Primary outcome
Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.
Time frame: follow-up 1 year after surgery
All patients go through a CT scan and clinical examination one year after surgery
2 secondary outcomes
Adverse Event Indicated in Case Report Formulary During the First 12 Months
Time frame: follow-up 1 year after surgery
Pain Post Operatively Measured by the VHPQ Questionnaires
Time frame: follow-up 1 year after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24880577Emanuelsson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf S Gunnarsson, professor study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quill suture application for repair or polypropylene mesh in people with Abdominal Hernias and Other Abdominal Wall Conditions and Post-operative Pain, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. (time frame: follow-up 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01586741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.