Actively Recruiting
Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis
Led by Karolinska Institutet · Updated on 2024-10-21
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with symptomatic rectus diastasis, a condition where the abdominal muscles separate, causing pain and instability. The trial aims to evaluate if laparoscopic abdominal wall reconstruction is a safe treatment option and whether it improves quality of life, trunk stability, and reduces pain. The study also compares two laparoscopic methods: suturing the linea alba alone or with added mesh. Participants will undergo one of two surgical procedures for abdominal wall reconstruction: either narrowing the linea alba using continuous sutures alone or using continuous sutures combined with mesh. Both methods are performed laparoscopically, and the study uses a randomized, double-blind design to compare their outcomes. During the study, participants will be monitored for recurrence of rectus diastasis over one year. Pain levels will be assessed using the Visual Analog Pain Scale, and questionnaires like SF-36 and VHPQ will evaluate quality of life and pain before and after surgery at 1 and 3 years. Abdominal stability will also be measured to understand the surgery's impact. The total duration of participation may extend up to 3 years for follow-up assessments.
CONDITIONS
Brief Title
Abdominal Rectus Diastasis (ARD) Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rectus diastasis 3 cm or larger
- Body mass index (BMI) of 28 kg/m2 or less
- Non-smoker
- Abdominal instability
- Abdominal wall and/or lower back pain despite physical therapy or structured exercise for at least 6 months
You will not qualify if you...
- Body mass index (BMI) greater than 28 kg/m2
- Current smoker
- Ongoing immunosuppressive therapy
- Pregnancy of 16 weeks gestational age or more within the last 12 months
- Currently pregnant or wishing to become pregnant
- Previous extensive abdominal wall surgery including hernia surgery (except cesarean section, appendectomy, small umbilical hernias)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo laparoscopic abdominal wall reconstruction using one of two surgical methods: narrowing of linea alba with continuous suture or with suture and mesh. Immediate care follows surgery.
1 surgical visit and follow-up visits during hospital stay
Duration - Up to 3 years
Participants attend follow-up visits to assess abdominal stability, pain, and quality of life after surgery.
Regular visits at 1 year and 3 years post-surgery
Trial Site Locations
Total: 1 location
1
Karolinska Institutet, Ersta Hospital
Stockholm, Region Stockholm, Sweden, SE-116 91
Actively Recruiting
Research Team
A
Anders Thorell, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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