Abdominal Rectus Diastasis (ARD) Reconstruction

NCT ID: NCT04182412

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Rectus Diastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Suture

laparoscopic narrowing of linea alba with continuous suture

Group Type ACTIVE_COMPARATOR

ARD

Intervention Type PROCEDURE

surgical reconstruction with laparoscopic technique

suture and mesh

narrowing of linea alba with continuous suture and mesh

Group Type ACTIVE_COMPARATOR

ARD

Intervention Type PROCEDURE

surgical reconstruction with laparoscopic technique

Interventions

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ARD

surgical reconstruction with laparoscopic technique

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anders Thorell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Thorell, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet, Ersta Hospital

Stockholm, Region Stockholm, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Anders Thorell, Professor

Role: CONTACT

+46 8 714 6541

Facility Contacts

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Anders Thorell, professor

Role: primary

+46 (0) 8 7146541 ext. 6541

Other Identifiers

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2019-01959

Identifier Type: -

Identifier Source: org_study_id

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