Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis

Rectus Abdominus; Diastasis, Complicating Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623594
• Other study ID #: ARD
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastasis, Muscle
• Rectus Abdominus; Diastasis, Complicating Delivery

Intervention

Procedure:
• Surgical repair of the diastasis
Repair of the diastasis with a double row plication using absorbable Quill suture

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm South General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Secondary	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.	One year
Secondary	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.	One year
Secondary	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.	One year