Abdominal Rectus Diastasis (ARD) Reconstruction

Not Applicable

Recruiting

• Conditions: Rectus Diastasis
• Interventions: Procedure: ARD

• Registration Number: NCT04182412
• Lead Sponsor: Karolinska Institutet

Brief Summary

The aim of this study is to investigate whether abdominal wall reconstruction through laparoscopic surgery can be recommended as a safe treatment alternative for patients with symptomatic rectus diastasis, and if this type of treatment leads to improved quality of life, trunk stability and reduced pain.

Detailed Description

Investigate whether surgical reconstruction with laparoscopic technique can lead to improved quality of Life, trunk stability and reduced pain in patients with symptomatic rectus diastasis. The study will also compare two different laparoscopic surgery methods for abdominal wall reconstruction: narrowing of linea alba with continuous suture with or without mesh.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-06-17
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Rectus diastasis ≥3 cm
• BMI =<28 kg/m2
• non smoker
• abdominal instability,
• abdominal wall and/or lower back pain despite physical therapy / structured physical exercise for at least 6 months

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Exclusion Criteria

• BMI >28 kg/m2
• Smoking
• Ongoing immunosuppressive therapy
• Current pregnancy ≥16 weeks gestational age for the last 12 months
• Pregnant or women who wish to become pregnant
• Previously extensive abdominal wall surgery incl hernia surgery (NOT including sectio, appendectomy, small umbilical herniae)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture	ARD	laparoscopic narrowing of linea alba with continuous suture
suture and mesh	ARD	narrowing of linea alba with continuous suture and mesh

Primary Outcome Measures

Name	Time	Method
Rate of recurrence	1 year	computed tomography

Secondary Outcome Measures

Name	Time	Method
SF-36 Quality of Life instrument	1 year, 3 years	The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. Higher scores mean a better outcome.
Visual Analog Pain Scale (VAS)	1 year, 3 years	Scale from 0 to 10, where 0 is no pain and 10 is the worst possible pain
Abdominal stability	1 year, 3 years	patient self-esteem by one question; do you feel that the instability of the abdominal wall has disappeared, yes/no/partially
VHPQ is a questionnaire for the assessment of pre- and postoperative pain	1 year, 3 years	The questionnaire comprises 20 questions The first six questions concern the level and duration of pain. The next seven questionsrelate to the impact on daily activities. The final questions deal with patient satisfaction and how physically demanding the patients regard their occupation. Pain intensity in the VHPQ is assessed using a 7-step fixed-point rating scale with steps linked to pain behavior rather than numbers or verbal descriptors of pain. Higher scores mean a worse outcome.

Trial Locations

Locations (1)

Karolinska Institutet, Ersta Hospital; 🇸🇪 Stockholm, Region Stockholm, Sweden