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NCT Number: NCT04182412

Abdominal Rectus Diastasis (ARD) Reconstruction

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.

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Key information

Conditions

Rectus Diastasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Ersta Hospital

Stockholm, Region Stockholm, SE-116 91, Sweden

Location status: Recruiting

Location contact

Anders Thorell, Ass. Prof.

PRINCIPAL_INVESTIGATOR

Anders Thorell, professor

CONTACT

[email protected]

+46 (0) 8 7146541 ext. 6541

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ARD

Procedure

surgical reconstruction with laparoscopic technique

Primary outcomes

  1. Rate of recurrence

    Time frame: 1 year

    computed tomography

Secondary outcomes

  1. Visual Analog Pain Scale (VAS)

    Time frame: 1 year, 3 years

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

  2. Abdominal stability

    Time frame: 1 year, 3 years

    patient self-esteem by one question; do you feel that the instability of the abdominal wall has disappeared, yes/no/partially

  3. SF-36 Quality of Life instrument

    Time frame: 1 year, 3 years

    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.

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

    Time frame: 1 year, 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anders Thorell, Professor

CONTACT

[email protected]

+46 8 714 6541

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis

Acronym: ARD

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2019
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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