Abdominal Rectus Diastasis (ARD) Reconstruction

Overview

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.

Full Title of Study: “Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 31, 2027

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.

Interventions

  • Procedure: ARD
    • surgical reconstruction with laparoscopic technique

Arms, Groups and Cohorts

  • Active Comparator: Suture
    • laparoscopic narrowing of linea alba with continuous suture
  • Active Comparator: suture and mesh
    • narrowing of linea alba with continuous suture and mesh

Clinical Trial Outcome Measures

Primary Measures

  • Rate of recurrence
    • Time Frame: 1 year
    • compute tomography

Secondary Measures

  • Visual Analog Pain Scale (VAS)
    • Time Frame: 1 year
    • Scale from 0 to 10, where 0 is no pain and 10 is the worst possible pain
  • Abdominal stability
    • Time Frame: 1 year
    • patient self-esteem by one question; do you feel that the instability of the abdominal wall has disappeared, yes/no/partially
  • RAND-36 Quality of Life instrument
    • Time Frame: 1 year
    • 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.
  • VHPQ is a questionnaire for the assessment of pre- and postoperative pain
    • Time Frame: 1 year
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Rectus diastasis ≥3 cm
  • BMI <30 kg/m2
  • non smoker
  • abdominal instability,
  • abdominal wall and/or lower back pain despite physical therapy / structured physical exercise for at least 6 months

Exclusion Criteria

  • BMI ≥30 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 abdominal wall surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anders Thorell, Professor – Karolinska Institutet
  • Overall Official(s)
    • Anders Thorell, Professor, Principal Investigator, Karolinska Institutet
  • Overall Contact(s)
    • Anders Thorell, Professor, +46 8 714 6541, anders.thorell@erstadiakoni.se

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