Abdominal Rectus Diastasis (ARD) Reconstruction (ARD)

Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis

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.

Study Overview

• Status: Recruiting
• Conditions: Rectus Diastasis
• Intervention / Treatment: Procedure: ARD

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Thorell, Professor; Phone Number: +46 8 714 6541; Email: anders.thorell@erstadiakoni.se

Study Locations

• Sweden
  • Region Stockholm
    • Stockholm, Region Stockholm, Sweden, SE-116 91
      • Recruiting
      • Karolinska Institutet, Ersta Hospital
      • Contact: Anders Thorell, professor; Phone Number: 6541 +46 (0) 8 7146541; Email: anders.thorell@erstadiakoni.se
      • Principal Investigator: Anders Thorell, Ass. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Suture; laparoscopic narrowing of linea alba with continuous suture	Procedure: ARD; surgical reconstruction with laparoscopic technique
Active Comparator: suture and mesh; narrowing of linea alba with continuous suture and mesh	Procedure: ARD; surgical reconstruction with laparoscopic technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrence	computed tomography	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale (VAS)	Scale from 0 to 10, where 0 is no pain and 10 is the worst possible pain	1 year, 3 years
Abdominal stability	patient self-esteem by one question; do you feel that the instability of the abdominal wall has disappeared, yes/no/partially	1 year, 3 years
SF-36 Quality of Life instrument	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.	1 year, 3 years
VHPQ is a questionnaire for the assessment of pre- and postoperative pain	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.	1 year, 3 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Anders Thorell, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopy; mesh reinforcement; abdominal stability
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Diastasis, Muscle
• Other Study ID Numbers: 2019-01959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No