Abdominal Rectus Diastasis (ARD) Reconstruction
ConditionRectus Diastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Rectus diastasis ≥3 cm
BMI =<28 kg/m2
non smoker
abdominal instability,
Disqualifiers
BMI >28 kg/m2
Smoking
Ongoing immunosuppressive therapy
Current pregnancy ≥16 weeks gestational age for the last 12 months
Trial design
Design model
Parallel
Treatments tested in this trial
ARD
Procedure/Surgerysurgical reconstruction with laparoscopic technique
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: SutureActive comparator 1 intervention
Group B: suture and meshActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of recurrence
computed tomography
Time frame
1 yearSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov