Rectus Diastasis
Conditions
Keywords
Laparoscopy, mesh reinforcement, abdominal stability
Brief 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.
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.
Interventions
PROCEDUREARD
surgical reconstruction with laparoscopic technique
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The randomization process will be initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.
Intervention model description
two different laparoscopic to one of techniques for abdominal wall reconstruction: narrowing of linea alba with continuous suture, with and without mesh
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrence | 1 year | computed tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scale (VAS) | 1 year, 3 years | Scale from 0 to 10, where 0 is no pain and 10 is the worst possible pain |
| Abdominal stability | 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 |
| SF-36 Quality of Life instrument | 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. |
| VHPQ is a questionnaire for the assessment of pre- and postoperative pain | 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. |
Countries
Sweden
Contacts
Primary ContactAnders Thorell, Professor
Outcome results
None listed