Rectus Abdominus; Diastasis, Complicating DeliveryNCT03623594
Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis
A study testing Surgical repair of the diastasis in people with Rectus Abdominus; Diastasis, Complicating Delivery, run by Karolinska Institutet.
Trial summary
There is insufficient evidence regarding the benefit from surgical reconstruction of post-partum abdominal rectus muscle diastasis. The purpose of this study is to evaluate the abdominal trunk function preoperatively and postoperatively in a group of women undergoing surgery for abdominal rectus muscle diastasis. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Rectus Abdominus; Diastasis, Complicating Delivery
- What is being tested?
- Surgical repair of the diastasis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Non-smoking women
- BMI <35
- Inter-recti distance >3cm
- Lack of response to standardized core stabilizing training
- >1 year since last partus
- No intention of further pregnancies
Who cannot join
- Inability to quit smoking
- BMI >35
- Inter-recti distance <3cm
- <1 year since last partus
- Further pregnancies not excluded
About this study
Official title: Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis: Outcome Measured With the Abdominal Trunk Function Protocol
There is insufficient evidence regarding the benefit from surgical reconstruction of post-partum abdominal rectus muscle diastasis. The purpose of this study is to evaluate the abdominal trunk function preoperatively and postoperatively in a group of women undergoing surgery for abdominal rectus muscle diastasis.
Read the detailed description
There is little evidence regarding the various treatment options of abdominal rectus muscle diastasis in post-partum women. The lack of evidence may, to a great extent, be explained by the lack of uniform criteria for assessing the trunk function and how the trunk function affects the ability to perform daily activities. To be able to evaluate the condition with symptomatic ARD a more comprehensive, multimodal instrument is therefore needed.
In collaboration with the surgical clinic and the physiotherapy clinic at Södersjukhuset a multimodal examination test was developed with the purpose to be able to evaluate the full picture of the condition.
The purpose of this study was to evaluate the effect of surgical reconstruction of post-partum abdominal rectus muscle diastasis in women with insufficient improvement after adequate physical training using a novel multimodal evaluation tool.
- Being tested
- Surgical repair of the diastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical repair of the diastasisProcedure or surgery
Repair of the diastasis with a double row plication using absorbable Quill suture
| Study group | Role | What they receive |
|---|---|---|
| Surgical repair of the diastasis | Experimental | Repair of the diastasis with a double row plication using absorbable Quill suture Receives: Procedure: Surgical repair of the diastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Trunk Function assessed with Disability Rating Index (DRI)
DRI is a self -report form that covers twelve activities related to daily activities. Each activity is rated on a visual analogue scale from 0 to 100. The total score thus ranges from 0 to 1200, with higher scores corresponding to better function.
Measured: One year
Secondary outcomes (3)
Health-related quality of life: SF-36
SF-36 is a set of generic and coherent quality-of-life measures. The form includes 36 items covering various aspects of quality of life. It gives eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability.
Measured: One year
Urogenital distress rated with Urinary Distress Inventory Short Form (UDI-6)
The UDI-6 is a six item symptom inventory, specific to symptoms associated with lower urinary tract dysfunction, and combines information on irritative, stress and obstructive symptoms. It was developed for self-administration and is intended to be used in combination with IIQ-7. Patients rate how much they experience impaired function of urinary incontinence and the extent to which urinary incontinence affects daily functioning with four response options per item. The mean score of items is multiplied by 33 1/3 to convert to a 0-100 scale. Higher scores indicate more symptom distress.
Measured: One year
Urinary stress incontinence rated with IIQ-7.
The IIQ-7 is a seven item life-impact assessment instrument specific to UI, and covers separate domains of physical activity, travel, social, and emotional health. It was developed for self-administration and is intended to be used in combination with UDI-6. Patients rate how much they experience impaired function of urinary incontinence and the extent to which urinary incontinence affects daily functioning with four response options per item. The mean score of items is multiplied by 33 1/3 to convert to a 0-100 scale. Higher scores indicate more impact on daily life.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jan 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectus Abdominus; Diastasis, Complicating DeliveryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Repair of the abdominal rectus diastasis with a double row plication using absorbable Quill
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Principal investigator, Gabriel Sandblom, Karolinska Institutet
- Investigators
- Gabriel Sandblom, Ass Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623594
- Sponsor's protocol ID
- ARD
- Status last verified
- Mar 2022
- First submitted
- 6 Aug 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis: Outcome Measured With the Abdominal Trunk Function Protocol
- ClinicalTrials.gov ID
- NCT03623594
- Acronym / sponsor ID
- ARD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is insufficient evidence regarding the benefit from surgical reconstruction of post-partum abdominal rectus muscle diastasis. The purpose of this study is to evaluate the abdominal trunk function preoperatively and postoperatively in a group of women undergoing surgery for abdominal rectus muscle diastasis.
Detailed description
There is little evidence regarding the various treatment options of abdominal rectus muscle diastasis in post-partum women. The lack of evidence may, to a great extent, be explained by the lack of uniform criteria for assessing the trunk function and how the trunk function affects the ability to perform daily activities. To be able to evaluate the condition with symptomatic ARD a more comprehensive, multimodal instrument is therefore needed.
In collaboration with the surgical clinic and the physiotherapy clinic at Södersjukhuset a multimodal examination test was developed with the purpose to be able to evaluate the full picture of the condition.
The purpose of this study was to evaluate the effect of surgical reconstruction of post-partum abdominal rectus muscle diastasis in women with insufficient improvement after adequate physical training using a novel multimodal evaluation tool.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repair of the abdominal rectus diastasis with a double row plication using absorbable Quill
| Arm | Type | Receives |
|---|---|---|
| Surgical repair of the diastasis | Experimental | Procedure: Surgical repair of the diastasisRepair of the diastasis with a double row plication using absorbable Quill suture |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking women
- BMI <35
- Inter-recti distance >3cm
- Lack of response to standardized core stabilizing training
- >1 year since last partus
Key exclusion criteria (5 listed)
- Inability to quit smoking
- BMI >35
- Inter-recti distance <3cm
- <1 year since last partus
- Further pregnancies not excluded
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 |
|---|---|---|
| Surgical repair of the diastasisRepair of the diastasis with a double row plication using absorbable Quill suture | Procedure or surgery | Surgical repair of the diastasis |
Primary outcome
Abdominal Trunk Function assessed with Disability Rating Index (DRI)
Time frame: One year
DRI is a self -report form that covers twelve activities related to daily activities. Each activity is rated on a visual analogue scale from 0 to 100. The total score thus ranges from 0 to 1200, with higher scores corresponding to better function.
3 secondary outcomes
Health-related quality of life: SF-36
Time frame: One year
Urogenital distress rated with Urinary Distress Inventory Short Form (UDI-6)
Time frame: One year
Urinary stress incontinence rated with IIQ-7.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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.
Gabriel Sandblom, Ass Prof principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Surgical repair of the diastasis in people with Rectus Abdominus; Diastasis, Complicating Delivery, run by Karolinska Institutet.
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 6 inclusion and 5 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Abdominal Trunk Function assessed with Disability Rating Index (DRI) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.