A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier.

PURPOSE: Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery. METHODS: This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL. RESULTS: No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34). CONCLUSION: Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.

Predicting formation of adhesions after gynaecological surgery: development of a risk score.

PURPOSE: Risk factors for post-surgical adhesions following gynaecological surgery have been identified, but their relative importance has not been precisely determined. No practical tool exists to help gynaecological surgeons evaluate the risk of adhesions in their patients. The purpose of the study was to develop an Adhesion Risk Score to provide a simple tool that will enable gynaecological surgeons to routinely quantify the risk of post-surgical adhesions in individual patients. METHODS: A group of European gynaecological surgeons searched the literature to identify the risk factors and the surgical operations reported as carrying a risk of post-surgical adhesions. Through consensus process of meetings and communication, a four-point scale was then used by each surgeon to attribute a specific weight to each item and collective agreement reached on identified risk factors and their relative importance to allow construct of a useable risk score. RESULTS: Ten preoperative and 10 intraoperative risk factors were identified and weighed, leading to the creation of two sub-scores to identify women at risk prior to and during surgery. The Preoperative Risk Score can range from 0 to 36, and the Intraoperative Risk Score from 3 to 31. Several thresholds between these limits may be used to identify women with low, medium, and high risk of post-surgical adhesions. CONCLUSIONS: Gynaecological surgeons are encouraged to use this Adhesion Risk Score to identify the risk of adhesions in their patients. This will allow better informed use of available resources to target preventive measures in women at high risk of post-surgical adhesions.

Nationwide linkage analysis in Scotland-Has mortality following hospital admission for Crohn's disease changed in the early 21st century?

BACKGROUND: National Scottish data were used to compare 3-year mortality in patients hospitalized for Crohn's disease (CD) between 1998-2000 and 2007-2009. METHODS: The linked Scottish Morbidity Records database was used to identify patients admitted with CD during two periods: Period 1 (1998-2000) and Period 2 (2007-2009). 3-year mortality and standardized mortality ratio (SMR) were determined and multivariable logistic regression analysis of associated factors was performed. Mortality was determined following four admission types: surgery-elective, surgery-emergency, medical-elective and medical-emergency. 3-year mortality was compared between study periods using age-standardized rates. RESULTS: The number of patients per 100,000 population hospitalized with CD per year was unchanged (15.7 [Period 1]; 14.4 [Period 2]). Overall crude and adjusted 3-year mortality rates were also unchanged (crude mortality 9.0%-9.1%, adjusted mortality odds ratio [OR]=0.87, 95% confidence interval [CI] 0.65-1.17; p=0.36). The adjusted 3-year mortality increased following elective surgery (Period 1: 1/303 [0.3%]; Period 2: 9/261 [3.4%]); OR=13.5 [CI 1.66-109.99]) and decreased following emergency medical admission (Period 1: 99/779 [12.7%]; Period 2:86/802 [10.7%]; OR=0.68 [CI 0.47-0.97]). Directly age-standardized mortality rates were similar (Period 1:338/10,000 person years [CI 282-394]; Period 2:333/10,000 person years [CI 276-390], p=0.2). On multivariable regression, age, deprivation status, comorbidity and the length of hospital stay were associated with mortality in both periods. High 3-year mortality was observed during both periods in patients between 50 and 64years (Period 1: 33/298 [11.1%, SMR=4.8 [CI 3.44-6.63], Period 2: 33/296 [11.1%, SMR=5.9 [4.14-8.22]) and over 65years(Period 1: 94/275 [34.2%, SMR=2.78 [CI 2.42-3.62], Period 2: 78/251 [31.1%, SMR=3.31 [2.64-4.11]). CONCLUSION: Nationwide linkage data demonstrate that overall 3-year mortality after hospitalization for CD is high, especially in patients over 50years, and has not altered between the time periods 1998-2000 and 2007-2009.

Adhesions after abdominal surgery in children.

PURPOSE: The objective of this study is to quantify the overall burden (operative and nonoperative) of small bowel obstruction caused by adhesions after laparotomy in children. METHODS: Data from the Scottish National Health Service Medical Record Linkage database were used to assess risk of an adhesion-related readmission in the 5 years after open abdominal surgery in children and adolescents younger than 16 years from April 1996 to March 1997. RESULTS: A total of 1581 children underwent abdominal surgery (ie, from duodenum downward). Patients undergoing surgery on the ileum had the highest risk of readmission because of adhesions in the subsequent 5 years after surgery (9.2%)--formation/closure of ileostomy had the greatest risk (25%); 6.5% of children were readmitted after general laparotomy, 4.7% after duodenal surgery, and 2.1% after colonic surgery. The incidence of readmissions was 0.3% after appendicectomy. The overall readmission rate was 5.3% (if appendicectomy was excluded) and 1.1% (if appendicectomy was included). CONCLUSION: This population-based study has demonstrated that children have a high incidence of readmissions owing to adhesions after lower abdominal surgery. The risks are related to the site and the type of the original surgery. The risk of further readmissions was highest in the first year but continued with time. The data enable surgeons to target antiadhesion strategies at procedures that lead to a high risk of adhesions.

Population-based analysis of the risk of adhesion-related readmissions after abdominal surgery in children.

PURPOSE: The aim of this study was to quantify the risk of adhesion-related readmissions after abdominal surgery in children. METHODS: This was a population-based study. One thousand five hundred eighty-one children younger than 16 years underwent laparotomy in 1996. Patients were identified from the Scottish Morbidity Records database and followed up for 4 years. RESULTS: In children younger than 5 years, 4.2% had a readmission "directly" owing to adhesions. In children younger than 16 years, 1.1% had a readmission directly owing to adhesions. The highest risk of readmission followed surgery on the small intestine (9.3%), followed by abdominal wall surgery (5.8%), duodenal surgery (2.6%), colonic surgery (2.1%), and appendicectomy (0.3%). 55% of all readmissions occurred in the first year. CONCLUSION: There was no difference in readmission rates between younger and older children when comparing the organ on which surgery was initially performed. The highest readmission rate followed small intestinal surgery and the lowest followed appendicectomy. The risk of readmission was highest in the first year.