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Prevention and Management of Pelvic Adhesions Tommaso Falcone, M.D. Professor and Chair

Prevention and Management of Pelvic Adhesions Tommaso Falcone, M.D. Professor and Chair Department of Obstetrics & Gynecology. Definition. Adhesion: abnormal joining of anatomical structures at sites where no such anatomical attachment should exist Categories

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Prevention and Management of Pelvic Adhesions Tommaso Falcone, M.D. Professor and Chair

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  1. Prevention and Management of Pelvic Adhesions Tommaso Falcone, M.D. Professor and Chair Department of Obstetrics & Gynecology

  2. Definition • Adhesion: abnormal joining of anatomical structures at sites where no such anatomical attachment should exist • Categories • De novo ( at operative site/other site) • Reformation (operative site/other site-other adhesiolysis) • Scoring system • Location, vascularity, type (thickness)

  3. Complications of adhesions • Within 1 year of laparotomy- 1 % develop adhesion related intestinal obstruction & 12 % will suffer a recurrence • Variation in incidence • Cause

  4. Complications of adhesions • Intestinal obstruction • Early 20 th century: primary cause strangulated external hernias • Now in western society-adhesions • Secondary to surgery colon & rectum, appendectomies, and gyn procedures

  5. Complications of adhesions • 17-29% of intestinal obstruction occur within 1 month of surgery • Recurrence increases with number of prior episodes • Recurrence 81 % with 4 or more admissions • Recurrence within 5 years

  6. Pain • Adhesions contain nerve fibers • Confounding variables • Restriction of free organ movement • 20-50 % patients with chronic pain have pelvic adhesions • No relationship between the extent of adhesions and severity of the pain

  7. Pelvic Pain & Adhesions • Consensus: • Adhesions may be the cause of pain in some but in others adhesions may be an incidental finding

  8. Laparoscopy & Adhesion formation • Laparoscopic adhesiolysis ( Diamond et al 1991) • Adhesion reformation noted in 66/68 subjects ( 97%) • Extent of pelvic adhesions reduced by half • De novo adhesion development in 12 % • Introduction of laparoscopy for abdominal procedures not associated with reduction of hospitalization rates for adhesive bowel obstruction

  9. Adhesion Reformation and De Novo Adhesion Formation Following Operative Laparoscopy- slide from Dr.Diamond Study Year N Reformed De Novo Diamond et al. 1991 62 67% tube 23% pelvic 80% ovary Canis et al. 1992 42 82% adnexa 21% adnexa Lundorff et al. 1991 31 60% tube 17% tube

  10. Surgery for Chronic Pain • Peters et al BJOG 1992 • RCT: surgery ( by laparotomy) versus no surgery • Netherlands • Control( N=24) and Surgery group (N=24) • Evaluation at 12 months no significant difference in pain scores • Patients with vascularized and dense adhesions involving bowel had relief

  11. Surgery for Chronic Pain • Swank et al Lancet 2003 • RCT ( double blinded) diagnostic scope and laparoscopic adhesiolysis • N=100 • 1 year follow up • No change or worsened pain • Control group: 58% • Study group: 43 % • More complications adhesiolysis group • No endometriosis patients

  12. Surgery for Infertility • One RCT-laparotomy (Tulandi et al 1990) • Salpingo-ovariolysis • CPR 24 months • Treated - 32 % & 45 % at 12 & 24 months compared with 11% and 16 % in controls.

  13. Summary • Adhesions cause morbidity & mortality • Surgical management unproven benefit • High Complication rate • Adhesions are caused by surgery ( laparotomy or laparoscopy) • Adhesion Prevention should be the goal

  14. Abnormal Repair ? • Inhibition of fibrinolysis • Fibroblasts invade fibrin matrix

  15. Risk Factors • Previous surgery • Ischemia • Thermal injury • Infection • Foreign body • Radiation

  16. Consensus Statements • “Adhesion prevention strategies should employed during all abdominal or pelvic surgery” • Royal College of Obstetrricians & Gynaecologists of the UK-2004

  17. Prevention • Surgical technique • Reduce infection risk • Antibiotics administered before the surgery starts • Excellent hemostasis • Gentle tissue handling • Use of irrigation to avoid desiccation

  18. Prevention • Limit use of cautery • Tissue approximation • Avoidance of ischemic suturing • Use fine non-reactive sutures • Peritoneal closure avoided • Controversial • C/S may be less adhesions with closure • Minimal exposure to foreign body

  19. Energy source • Energy & Adhesion formation • Laser • Bipolar • Unipolar • Harmonic scalpel • None have been shown to be superior

  20. Classes of Anti-adhesions • Pharmacologic Agents • Anti-inflammatory Agents (questionable efficacy) • NSAIDS • Corticosteroids • Antihistamines • Antibiotics

  21. Pharmacologic agents • Fibrinolytic Agents • Anticoagulants • Heparin added to peritoneal irrigation • Jansen et al 1988 • RCT –no benefit

  22. Mechanical Separation • Separate traumatized peritoneal surfaces between day 3 & 5. • Site specific • Broad coverage

  23. Interceed • Fabric composed of oxidized, regenerated cellulose • Preclinical studies with Interceed demonstrated: • Negligible tissue response • Absorption from the peritoneal cavity in <28 days • Reduction of extent and severity of postsurgical adhesions in standardized animal models

  24. Interceed: How to use it ? • Operative site perfect hemostasis • Remove all fluid • Completely cover the affected site • DO NOT wrap tube and ovary together • Adhesions increase

  25. Pivotal study-Interceed • Azziz, R, and the INTERCEED (TC7) Adhesion Barrier Study Group II. Microsurgery Alone or With INTERCEED Absorbable Adhesion Barrier for Pelvic Sidewall Adhesion Re-Formation. Surg. Gynecol. Obstet.,1993; 177: 135-139 • Increased number of patients from 74 to 134 • Increased number of centers from 9 to 13

  26. Results: Absence or presence of adhesions Significantly fewer sidewalls were observed with adhesions when treated with Interceed (66 versus 102)

  27. Seprafilm • Seprafilm is composed of sodium hyaluronate and carboxymethylcellulose • Provides physical separation of damaged tissue during early wound repair • Resorbs from peritoneal cavity in 7 days, excreted within 28 days • Effective in animal models prior to this study

  28. Hyaluronic acid and carboxymethylcellulose (Seprafilm) • Between bowel and anterior abdominal wall • Substantial literature • Difficult to apply by laparoscopy • Mean of 4.5 sheets per patient

  29. Seprafilm • Colorectal procedures (Becker et al 1996) • Separate the bowel from anterior abdominal wall • 51 % of treated women were adhesion free at follow up compared to 6 % • Extent decreased • Dense adhesions present in 15 % of the treated and 58 % of controls

  30. Diamond, Michael P. The Seprafilm Adhesion Study Group. Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fertility and Sterility 1996. Vol 66, No 6; 904-10.

  31. In patients with at least one anterior incision: incidence of patients with no adhesions • to anterior uterine surface was 39% in Seprafilm group; 6% in no treatment group • To the posterior uterine surface: 13% versus 8%(NS)

  32. Broad Coverage • Adept (4 % icodextrin) solution • Glucose polymer • Used for intraperitoneal dialysis • Recently approved in the USA • Has been used >100,000 patients • Hydroflotation ( constant fluid barrier) • Long intraperitoneal residence-3-4 days • Absorbed, metabolized and excreted by the kidney

  33. HO OH H O OH Z HO O O O O OH OH OH O H O OH OH OH c y m Stucture of Icodextrin

  34. Icodextrin solution (Adept 4 %) • 1 L or 1.5 L bags • Handles like normal saline • Isosmolar • Irrigate with fluid (100ml) every 30 minutes and leave 1 liter in the pelvis • Pilot study- approximately 2 liters were used for irrigation during the procedure

  35. Icodextrin solution (Adept 4 %) • No difference in healing of incision sites • Fluid leaking from port sites: 13 %

  36. Icodextrin solution (Adept 4 %) • CID • Allergy to cornstarch • Infection • Laparotomy • Bowel resection/repair, appendectomy • Rare hypersensitivity reactions, pulmonary edema • Vulvar swelling

  37. Icodextrin solution (Adept 4 %) • No data on fertility outcomes • Pain data-shows no short term difference compared with RL

  38. Clinical study • Adept (icodextrin 4% solution) reduces adhesions after laparoscopic surgery for adhesiolysis: a double-blind, randomized, controlled studyBy Brown et al. Fertility and Sterility Vol. 88, November 2007, 1413-1426. • Iso-osmotic biodegradable starch • Residual time- • Safety and Effectiveness data-1 liter cleared between 18-50 hours • Report says 4 days

  39. Methods • Design- Multicenter, prospective, randomized, double-blind study to test the efficacy and safety of Adept (icodextrin 4% Solution) • Patient Population- • All patients 18 y.o. or older • Pre-Op Exclusion criteria- use of concomitant use systemic steroids, antineoplastic agents, radiation therapy, pregnancy, active pelvic or abdominal infection, cancer, allergy to starch based polymers • Intra-op Exclusion criteria- unplanned surgery, surgery necessitating opening the bowel, (excluding appendectomy), any laparotomy procedure, use of another adhesion barrier. • Adhesion site exclusion- patients having fewer than 3 available anatomical study sites with adhesions, if fewer than 3 adhesions were lysed, removal of any anatomical sites being scored for the study, inability to clearly visualize all available anatomical score sites

  40. Patient Population (cont.) • Laparoscopic surgery was planned for a gynecologic procedure that included adhesiolysis • Second look surgery follow up was to occur 4-8 weeks later • 410 patients were to complete study • 205 patients received Adept • 205 patients received Lactated Ringers

  41. Methods ( cont.) • Conducted at 16 referral centers • Double blinded study of anti-adhesion device • Double blinding possible because adept and lactated ringers (control) are both clear and odorless solutions with similar viscosities • Computer generated randomization on 1:1 basis • Solution bags were presented in identical packages • Outer wrap contained the study code and patient number on an identification label

  42. Methods ( cont.) • Study procedures • First laparoscopic procedure took place. Confirmation of no intraop exclusion criteria then lead to randomization. • 23 or all available anatomical sites for adhesion scoring were videotaped during the surgery • The presence or absence and extent of adhesions at all anatomical sites recorded • Throughout procedure abdomen was irrigated with a min. of 100ml of study soln. every 30 minutes • No limit of volume for irrigation, total volume recorded at end of case • All remaining soln. irrigated out at end of procedure, then and 1000 ml of the study soln. was instilled from a fresh bag. • Patients given diary to record any adverse events and meds

  43. Methods (cont.) • Patient scheduled for f/u Lsx surgery in 4-8 weeks • second Lsx surgery took place with video taping and scoring of all available anatomical sites.

  44. Methods (cont.) Adhesion scoring- 23 available anatomical sites: anterior peritoneum (caudal anterior, cephalad anterior right, cephalad anterior left), small bowel, anterior uterus, posterior uterus, omentum, large bowel (left and right), rectosigmoid, cul-de-sac (posterior), right pelvic sidewall, left pelvic sidewall, right ovary ( lateral, medial, fossa), left ovary ( lateral, medial, fossa), right Fallopian tube, right ampulla, left Fallopian tube, left ampulla

  45. Methods (cont.) • Scoring- each site-AFS score used • Extent defined as: • Localized: less than 1/3 of the adhesion site covered. • Moderate: 1/3-2/3 of the adhesion site covered • Extensive: more than 2/3 of the adhesion site covered Severity of adhesions defined as: - Mild: filmy and avascular adhesions - Severe: dense, cohesive, or vascular adhesions Minimum of three adhesions had to be lyzed at initial surgery and the sites recorded

  46. Video Review Process Used to ensure consistency of adhesion scoring between study sites All investigators trained on adhesion assessment process 1st three videos of each investigator were reviewed by an independent reviewer, if deemed acceptable, then one in every five subsequent videos were reviewed. If any video found unacceptable, videos for next three patients reviewed until 3 consecutive videos acceptable- no mention how these recordings were included in the study

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