N/A
N=89
A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Abdominal Hernias and Other Abdominal Wall Conditions · Post-operative Pain · Recurrence
Bottom Line
View on ClinicalTrials.gov: NCT01586741 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. — 2; 3; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Quill suture application for repair or polypropylene mesh (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska Institutet
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. |
2; 3; 26 | — |
| SECONDARY Adverse Event Indicated in Case Report Formulary During the First 12 Months |
— | — |
| SECONDARY Pain Post Operatively Measured by the VHPQ Questionnaires |
— | — |
Summary
This is a three armed prospective randomized trial that will compare two different surgical techniques for reconstruction of the abdominal wall diastasis with a conservative treatment procedure.
The study hypothesis:
Which surgical approach provides the safest and best long term results for patients with abdominal wall diastasis either the insertion of net alternative with a double row suture or exercise alone?
Eligibility Criteria
Inclusion Criteria
- Abdominal wall diastasis> 3 cm
- Discomfort or tenderness in the abdominal wall
- Desire for abdominal wall reconstruction
- Women have undergone at least one birth
- Smoking cessation 1 month pre-and 3 months post-operatively
Exclusion Criteria
- <18 years old
- Ongoing pregnancy
- Ongoing breastfeeding
- Current immunosuppressive therapy
Data sourced from ClinicalTrials.gov (NCT01586741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.