Abdominal Rectus Diastasis (ARD) Reconstruction

NCT04182412 | Recruiting

• 1 other identifier: 2019-01959
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectus Diastasis

Keywords

Laparoscopy; mesh reinforcement; abdominal stability

Outcome Measures

Primary Outcomes (1)

• Rate of recurrence

  computed tomography

  1 year

Secondary Outcomes (4)

• Visual Analog Pain Scale (VAS)

  1 year, 3 years

• Abdominal stability

  1 year, 3 years

• SF-36 Quality of Life instrument

  1 year, 3 years

• VHPQ is a questionnaire for the assessment of pre- and postoperative pain

  1 year, 3 years

Study Arms (2)

Suture

ACTIVE COMPARATOR

laparoscopic narrowing of linea alba with continuous suture

Procedure: ARD

suture and mesh

ACTIVE COMPARATOR

narrowing of linea alba with continuous suture and mesh

Procedure: ARD

Interventions

ARD PROCEDURE

surgical reconstruction with laparoscopic technique

Suture; suture and mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Ersta Hospital

Stockholm, Region Stockholm, SE-116 91, Sweden

RECRUITING

Study Officials

• Anders Thorell, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Thorell, Professor

CONTACT

+46 8 714 6541; anders.thorell@erstadiakoni.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomization process will be initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: two different laparoscopic to one of techniques for abdominal wall reconstruction: narrowing of linea alba with continuous suture, with and without mesh

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: December 2, 2019
• Study Start: June 17, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)