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Completed

NCT Number: NCT03623594

Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis

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.

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Key information

Conditions

Rectus Abdominus; Diastasis, Complicating Delivery

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical repair of the diastasis

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Health-related quality of life: SF-36

    Time frame: 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.

  2. Urogenital distress rated with Urinary Distress Inventory Short Form (UDI-6)

    Time frame: 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.

  3. Urinary stress incontinence rated with IIQ-7.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Stockholm South General Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Aug 9, 2018
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.