Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis

Not Applicable

Completed

• Conditions: Rectus Abdominus; Diastasis, Complicating Delivery
• Interventions: Procedure: Surgical repair of the diastasis

• Registration Number: NCT03623594
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-03-31
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-09
• Study Completion: 2021-03-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical repair of the diastasis	Surgical repair of the diastasis	Repair of the diastasis with a double row plication using absorbable Quill suture

Primary Outcome Measures

Name	Time	Method
Abdominal Trunk Function assessed with Disability Rating Index (DRI)	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.

Secondary Outcome Measures

Name	Time	Method
Urogenital distress rated with Urinary Distress Inventory Short Form (UDI-6)	One year	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.
Health-related quality of life: SF-36	One year	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.
Urinary stress incontinence rated with IIQ-7.	One year	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.