PART 4 – SUMMARY OF EVIDENCE Provide an overview of all key journal articles or research published in the public domain related to the proposed service that is for your application (limiting these to the English language only). Please do not attach full text articles, this is just intended to be a summary. Type of study design* Title of journal article or research project (including any identifier or study lead if relevant) description of research (max 50 words)** Website link to journal article or research (if available) Date of 1. Review A systematic review on the outcomes of correction of diastasis of the recti. Hickey F, JG, Khanna A. Seven studies report that patient satisfaction was high following abdominal rectus repair surgery Hernia 2011 2. Review A systematic review of outcomes of abdominoplasty Staalesen T, Elander A, Strandell A, Bergh C. One small controlled study on abdominoplasty was found indicating a positive effect on quality-of-life J Plastic Surgery and Hand Surgery 2012 *
3. Prospective analysis Correlation between abdominal rectus diastasis width and abdominal muscle strength , , , 57 patients underwent rectus diastasis repair and there was a strong correlation between intraoperatively measured rectus diastasis width below the umbilicus and flexion and isometric abdominal muscle strength https://www.ncbi.nlm.nih.gov/pubmed/25766128 2015 4. Review Rectus Abdominis diastasis Akram J. Matzen SH 28 studies were included, representing 3725 patients. Post surgical repair the was high and recurrence was zero. https://www.ncbi.nlm.nih.gov/pubmed/24256310 J Plas. Surg Hand Surg. 2014 term
6. Surgical technique Abdominoplasty and abdominal wall rehabilitation: a comprehensive approach Ramirez OM 104 patients undergoing a 4 surgical approach. 1 required re tightening. https://www.ncbi.nlm.nih.gov/pubmed/10627012 Reconstr Surg 2000 7. Retrospective analysis An aesthetic classification of the abdomen based on the myoaponeurotic layer Nahas FX. Classification of myoaponeutrotic deformities. 88 patients reviewed to evaluate the best surgical option https://www.ncbi.nlm.nih.gov/pubmed/11711966 Reconstr Surg. 2001 8. Cross sectional study The normal width of the linea alba in nulliparous women Beer GM, Shuster A, Seifert B et al Measurement of normal linea alba width in 150 nulliparous women. https://www.ncbi.nlm.nih.gov/pubmed/19637295 Clin Anat. 2009
9. Prospective randomised Alternatives in the treatment of abdominal rectus muscle diastasis: an evaluation. Karolinska Institute, Dept of Clinical Science, Intervention and Technology 56 patients with a rectus diastasis than 3 cm have physical symptoms and poorer quality of life than an population. Surgical intervention improves patient comfort and improves quality of life. https://openarchive.ki.se/xmlui/handle/10616/42245 2014
12. Prospective randomised control trial Early complications, pain and quality of life after reconstructive surgery for abdominal rectus muscle diastasis: A three-month follow-up Emanuelsson P. Gunnarson U. Strigard K. B. >3cm rectus divarication repair in 57 patients comparing 2 techniques. Both techniques reliable with similar post operative pain. Mesh repair produced improved muscle strength. J Plas. Reconstr. Aesth Surg 2014; 13. Prospective trial Abdominoplasty Improves Low Back Pain and Urinary Incontinence Taylor DA, Merten SL, Sandercoe GD, Gahanakari D et al 214 patients following abdominoplasty & rectus diastasis repair. At 6 months showed significant improvement in low back pain & urinary incontinence. 2016 conference paper Australasian Society of Aesthetic Plastic Surgeons Gold Coast, Australia.
14. Prospective study The relief of low back pain with the WARP abdominoplasty Toranto IR Back pain alleviated in 24 of 25 patients following wide abdominal rectus plication abdominoplasty. Increase in muscle strength & intervertebral disc space. https://www.ncbi.nlm.nih.gov/pubmed/2138335 Plast Reconstr Surg. 1990 15. Prospective trial Wide abdominal rectus plication abdominoplasty for the treatment of chronic intractable low back pain , , , et al 8 patients had long alleviation of chronic back pain following wide abdominal rectus plication. https://www.ncbi.nlm.nih.gov/pubmed/21200216 2011
16. Case study Functional Improvement Following Diastasis Rectus Abdominus Repair in an Active Duty Navy Female , , Restored abdominal function (in an active navy female) following abdominoplasty and imbrication of the abdominal wall diastasis. https://www.ncbi.nlm.nih.gov/pubmed/27483541 2016 Aug 17. Prospective controlled longitudinal study The relationships between distance measured by ultrasound imaging and abdominal muscle function in postpartum women: a follow-up study Liaw LJ, Hsu MJ, Liao CF, Liu MF, Hsu AT 40 post partum women (& 20 nulliparous women) had inter rectus distance & abdominal muscle function assessed. At 6 months post partum diastasis & muscle function had not returned to normal. https://www.ncbi.nlm.nih.gov/pubmed/21289454 J Orthop Sports Phys Ther. 2011
18. Prospective trial Correlation between Abdominal Diastasis Width and Abdominal Muscle Strength. Gunnarsson U, Stark B, Dahlstrand U, Strigard K. 57 patients underwent abdominal rectus diastasis repair. There was a strong correlation between the diastasis width & abdominal muscle strength. Dig Surg 2015 19. Opinion Is the lumbodorsal fascia necessary Gracovetsky S The lumbodorsal fascia is an important structure in spinal kinetics https://www.unboundmedicine.com/medline/citation/19083674/ Journal of Bodywork and Movement Therapies 2008 20. Prospective trial A study of postural changes after abdominal rectus plication abdominoplasty Mazzocchi M, LA, Di Ronza S, Iodice P, Saggini R, Scuderi N 46 patients undergoing abdominoplasty & rectus diastasis repair. Improvement in posture & psychological factors & quality of life. https://www.ncbi.nlm.nih.gov/pubmed/23132640 Hernia 2014
21. Case series pressure increases stiffness of the lumbar spine. Hodges PW, Eriksson AE, Shirley D, Gandevia SC. Analysis of spinal stiffness in 3 patients in relationship to pressure. There was a correlation. J Biomech. 2005 22. Lab research pressure mechanism for stabilising the lumbar spine Cholewicki J, Juluru K, McGill SM. They designed a model to imitate an intra abdominal pressure mechanism for stabilizing the lumbar spine. It appears preferable in tasks that demand trunk extensor moment such as lifting or jumping to increase pressure. J Biomech. 1999
This procedure is the same as for descriptor 30176 (but this only includes intra abdominal or pelvic tumours, not including babies/pregnancy) The procedure offers superiority over no treatment at all. The procedure offers equivalence to having the procedure entirely self funded. Please advise if the overall clinical claim is for: Superiority Non-inferiority Below, list the key health outcomes (major and minor – prioritising major key health outcomes first) that will need to be specifically measured in assessing the clinical claim of the proposed medical service versus the comparator: Safety Outcomes: List safety outcomes here Clinical Effectiveness Outcomes: Patient reported outcomes of improvement in quality of life, improvement in low back and abdominal pain and improvement in urinary incontinence have been proven in several clinical papers. PART 7 – INFORMATION ABOUT ESTIMATED UTILISATION Estimate the prevalence and/or incidence of the proposed population: The incidence of chronic back pain greater than two years following pregnancy has been reported between 5% to 21.1%. Persistent urinary incontinence rates 10 to 12 years after pregnancy range between 25% to 37.9%. Vaginal delivery is associated with a higher incidence of long term stress incontinence. The Australian female population is approximately 11million. 24% of Australian women are childless in their lifetime. A 20% incidence of chronic back pain and a 35% incidence of urinary incontinence in the remaining 8.36m childbearing women would mean up to 1.67m Australian women are suffering chronic back pain and 3.2m stress incontinence. Both these conditions negatively affect the quality of life and are usually under reported. Estimate the number of times the proposed medical service(s) would be delivered to a patient per year: Approximately1000 patients per year. How many years would the proposed medical service(s) be required for the patient? 1 (one procedure per patient) Estimate the projected number of patients who will utilise the proposed medical service(s) for the first full year: 1000 Estimate the anticipated uptake of the proposed medical service over the next three years factoring in any constraints in the health system in meeting the needs of the proposed population (such as supply