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Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis

Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis: Outcome Measured With the Abdominal Trunk Function Protocol

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03623594
Enrollment
60
Registered
2018-08-09
Start date
2015-01-01
Completion date
2021-03-31
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectus Abdominus; Diastasis, Complicating Delivery

Brief 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.

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.

Interventions

PROCEDURESurgical repair of the diastasis

Repair of the diastasis with a double row plication using absorbable Quill suture

Sponsors

Stockholm South General Hospital
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Repair of the abdominal rectus diastasis with a double row plication using absorbable Quill

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Inability to quit smoking * BMI \>35 * Inter-recti distance \<3cm * \<1 year since last partus * Further pregnancies not excluded

Design outcomes

Primary

MeasureTime frameDescription
Abdominal Trunk Function assessed with Disability Rating Index (DRI)One yearDRI 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.

Secondary

MeasureTime frameDescription
Health-related quality of life: SF-36One yearSF-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.
Urogenital distress rated with Urinary Distress Inventory Short Form (UDI-6)One yearThe 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.
Urinary stress incontinence rated with IIQ-7.One yearThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026