Rectus DiastasisARDNCT04182412
Abdominal Rectus Diastasis (ARD) Reconstruction
A study testing ARD in people with Rectus Diastasis, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectus Diastasis
- What is being tested?
- ARD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jun 2019to 31 May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Ersta Hospital
Stockholm, Region Stockholm, SE-116 91
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectus Diastasis
- Being tested
- ARD
- Keywords
- Laparoscopy, mesh reinforcement, abdominal stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARDProcedure or surgery
surgical reconstruction with laparoscopic technique
| Study group | Role | What they receive |
|---|---|---|
| Suture | Active comparator | laparoscopic narrowing of linea alba with continuous suture Receives: Procedure: ARD |
| suture and mesh | Active comparator | narrowing of linea alba with continuous suture and mesh Receives: Procedure: ARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence
computed tomography
Measured: 1 year
Secondary outcomes (4)
Visual Analog Pain Scale (VAS)
Scale from 0 to 10, where 0 is no pain and 10 is the worst possible pain
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 year, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start17 Jun 2019
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectus DiastasisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two different laparoscopic to one of techniques for abdominal wall reconstruction: narrowing of linea alba with continuous suture, with and without mesh
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182412
- Sponsor's protocol ID
- 2019-01959
- Other IDs
- 2019
- Acronym
- ARD
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No