Abdominal Rectus Diastasis (ARD) Reconstruction

Karolinska Institutet110 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Rectus Diastasis

Interventions

ARDPROCEDURE

surgical reconstruction with laparoscopic technique

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Karolinska Institutet, Ersta Hospital

Stockholm, Region Stockholm, Sweden

RECRUITING

Outcomes

Primary Outcomes

Rate of recurrence

computed tomography

Time frame: 1 year

Secondary Outcomes

Visual Analog Pain Scale (VAS)

Scale from 0 to 10, where 0 is no pain and 10 is the worst possible pain

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 1 year, 3 years

Central Contacts

Anders Thorell, Professor

CONTACT

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

Data from ClinicalTrials.gov

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