Delayed Versus Early Laparoscopic Appendectomy for Adult Patients With Acute Appendicitis: A Randomized Controlled Trial.

OBJECTIVE: To assess whether delaying appendectomy until the following morning is non-inferior to immediate surgery in those with acute appendicitis presenting at night. BACKGROUND: Despite a lack of supporting evidence, those with acute appendicitis who present at night frequently have surgery delayed until the after morning. METHODS: The delay trial is a noninferiority randomized controlled trial conducted between 2018 and 22 at 2 tertiary care hospitals in Canada. Adults with imaging confirmed acute appendicitis who presented at night (8:00 pm -4:00 am ). Delaying surgery until after 6:00 am was compared with immediate surgery. The primary outcome was 30-day postoperative complications. An a prior noninferiority margin of 15% was deemed clinically relevant. RESULTS: One hundred twenty-seven of the planned 140 patients were enrolled in the Delayed Versus Early Laparoscopic Appendectomy (DELAY) trial (59 in the delayed group and 68 in the immediate group). The two groups were similar at baseline. The mean time between the decision to operate and surgery was longer in the delayed group (11.0 vs 4.4 hours, P < 0.0001). The primary outcome occurred in 6/59 (10.2%) of those in the delayed group versus 15/67 (22.4%) of those in the immediate group ( P = 0.07). The difference between groups met the a priori noninferiority criteria of +15% (risk difference -12.2%, 95% CI: -24.4% to +0.4%, test of noninferiority P < 0.0001). CONCLUSIONS: The DELAY study is the first trial to assess delaying appendectomy in those with acute appendicitis. We demonstrate the noninferiority of delaying surgery until the after morning.

The Impact of Multidisciplinary Conferences on Treatment Plans for Patients With Inflammatory Bowel Disease in a Tertiary Canadian Centre.

BACKGROUND: Multidisciplinary conference presentation may provide recommendations for diagnosis, monitoring and treatment for patients with inflammatory bowel disease. METHODS: A prospective observational study was completed evaluating if case presentation resulted in a direct change in management for patients presented over a 2-year period in a tertiary Canadian centre. Change in management was defined as hospital admission, surgery or surgical referral, start/change in biologic therapy or other medication or initiation of parenteral nutrition. Secondary outcomes included the involvement of specialists and other referrals. Data were analyzed using frequencies and means with standard deviations. RESULTS: In 63 multidisciplinary conferences, 181 patients were presented, of whom 136 patients met the inclusion criteria of inflammatory bowel disease (Crohn's n = 45, ulcerative colitis n = 88, undifferentiated n = 3). The majority were outpatient cases 110 (81%). Indications included 71 (52%) patients presented for IBD management with diagnosis > 1 year, 37 (27%) with an acute IBD flare in a chronic patient (>1 year since diagnosis) and 24 (18%) with new diagnosis of IBD. Change in management was recommended in 35 (26%) patients. The most common change was referral to surgery in 17 (13%), surgery in 12 (9%) or change in biologic therapy 11 (8%). Compliance with the recommendations was 85%. There was frequent specialist involvement in case discussions (gastroenterologist 100%, surgeon 60%, radiologist 68% and pathologist 32%). CONCLUSIONS: Presentation of complex inflammatory bowel disease cases at multidisciplinary conference leads to a direct change in treatment in one quarter of cases, with surgical referral as the most frequent outcome.

The Standardization of Outpatient Procedure (STOP) Narcotics: A Prospective Health Systems Intervention to Reduce Opioid Use in Ambulatory Breast Surgery.

BACKGROUND: During the past 15 years, opioid-related overdose death rates for women have increased 471%. Many surgeons provide opioid prescriptions well in excess of what patients actually use. This study assessed a health systems intervention to control pain adequately while reducing opioid prescriptions in ambulatory breast surgery. METHODS: This prospective non-inferiority study included women 18-75 years of age undergoing elective ambulatory general surgical breast procedures. Pre- and postintervention groups were compared, separated by implementation of a multi-pronged, opioid-sparing strategy consisting of patient education, health care provider education and perioperative multimodal analgesic strategies. The primary outcome was average pain during the first 7 postoperative days on a numeric rating scale of 0-10. The secondary outcomes included medication use and prescription renewals. RESULTS: The average pain during the first 7 postoperative days was non-inferior in the postintervention group despite a significant decrease in median oral morphine equivalents (OMEs) prescribed (2.0/10 [100 OMEs] pre-intervention vs 2.1/10 [50 OMEs] post-intervention; p = 0.40 [p < 0.001]). Only 39 (44%) of the 88 patients in the post-intervention group filled their rescue opioid prescription, and 8 (9%) of the 88 patients reported needing an opioid for additional pain not controlled with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) postoperatively. Prescription renewals did not change. CONCLUSION: A standardized pain care bundle was effective in minimizing and even eliminating opioid use after elective ambulatory breast surgery while adequately controlling postoperative pain. The Standardization of Outpatient Procedure Narcotics (STOP Narcotics) initiative decreases unnecessary and unused opioid medication and may decrease risk of persistent opioid use. This initiative provides a framework for future analgesia guidelines in ambulatory breast surgery.

Standardization of Outpatient Procedure (STOP) Narcotics: A Prospective Non-Inferiority Study to Reduce Opioid Use in Outpatient General Surgical Procedures.

BACKGROUND: There has been a dramatic rise in opioid abuse, and diversion of excess, unused prescriptions is a major contributor. We assess the impact of implementing a new standardized pain care bundle to reduce postoperative opioids in outpatient general surgical procedures. STUDY DESIGN: This study was designed to demonstrate non-inferiority for the primary end point: patient-reported average pain in the first 7 postoperative days. We prospectively evaluated 224 patients who underwent laparoscopic cholecystectomy or open hernia repair (inguinal, umbilical) pre-intervention to 192 patients post-intervention. We implemented a multimodal intra- and postoperative analgesic bundle, including promoting co-analgesia, opioid-reduced prescriptions, and patient education designed to clarify patient expectations. Patients completed a brief pain inventory at their first postoperative visit. Groups were compared using chi-square test, Mann-Whitney U test, and independent samples t-test, where appropriate. RESULTS: No difference was seen in average postoperative pain scores in the pre- vs post-intervention groups (2.3 vs 2.1 of 10; p = 0.12). The reported quality of pain control improved post-intervention (good/very good pain control in 69% vs 85%; p < 0.001). The median total morphine equivalents for prescriptions filled in the post-intervention group were significantly less (100; interquartile range 75 to 116 pre-intervention vs 50; interquartile range 50 to 50 post-intervention; p < 0.001). Only 78 of 172 (45%) patients filled their opioid prescription in the post-intervention group (p < 0.001), with no significant difference in prescription renewals (3.5% pre-intervention vs 2.6% post-intervention; p = 0.62). CONCLUSIONS: For outpatient open hernia repair and cholecystectomy, a standardized pain care bundle decreased opioid prescribing significantly and frequently eliminated opioid use, and adequately treating postoperative pain and improving patient satisfaction.

Corticosteroid response predicts success of laparoscopic splenectomy in treating immune thrombocytopenia.

BACKGROUND: Laparoscopic splenectomy is a second-line therapy for immune thrombocytopenia with a sustained success rate of 66%. In a climate of new available medical therapies for immune thrombocytopenia, the comparative safety and efficacy of laparoscopic splenectomy are worthy of attention. The purpose of this study is to identify factors predictive of laparoscopic splenectomy success that will enable preoperative prognostication. METHODS: A retrospective cohort study was conducted of patients undergoing laparoscopic splenectomy for immune thrombocytopenia. The data collected evaluated response to medical and surgical therapy, which was defined on a platelet level of 50 × 109/L with no bleeding events. Univariate and multivariate analyses were conducted to evaluate factors predictive of laparoscopic splenectomy success, with an additional subanalysis planned to assess for laparoscopic splenectomy safety in individuals ≥65 years. RESULTS: One hundred forty-one patients were reviewed. Operative outcomes showed a 3.6% conversion rate and 8.5% complication rate. Disease remission was achieved in 78.7% of patients. Response to initial corticosteroid therapy was associated with a laparoscopic splenectomy success rate of 90% and increased odds of surgical success by 5.58 over individuals with no response to corticosteroids. Age did not confer an increased risk of failure or complications. CONCLUSION: Laparoscopic splenectomy is a safe and effective intervention for immune thrombocytopenia regardless of age. Initial response to corticosteroids is associated with laparoscopic splenectomy success rate of 90% and improved odds of surgical success. Laparoscopic splenectomy should be the standard second-line therapy for immune thrombocytopenia, especially in patients responding to corticosteroids.

Why do Asian-American women have lower rates of breast conserving surgery: results of a survey regarding physician perceptions.

BACKGROUND: US Asian women with early-stage breast cancer are more likely to receive a modified radical mastectomy (MRM) than White women, contrary to clinical recommendations regarding breast conserving treatment (BCT). METHODS: We surveyed physicians regarding treatment decision-making for early-stage breast cancer, particularly as it applies to Asian patients. Physicians were identified through the population-based Greater Bay Area Cancer Registry. Eighty (of 147) physicians completed a questionnaire on sociodemographics, professional training, clinical practices, and perspectives on the treatment decision-making processes. RESULTS: The most important factors identified by physicians in the BCT/MRM decision were clinical in nature, including presence of multifocal disease (86% identified this as being an important factor for selecting MRM), tumor size (71% for MRM, 78% for BCT), cosmetic result (74% for BCT), and breast size (50% for MRM, 55% for BCT). The most important reasons cited for the Asian treatment patterns were patient attitudes toward not needing to preserve the breast (53%), smaller breast sizes (25%), and fear and cultural beliefs (12%). CONCLUSION: These survey results suggest that physicians perceive major roles of both clinical and cultural factors in the BCT/MRM decision, but cultural factors may be more relevant in explaining surgical treatment patterns among Asians.

Dietary controlled carcinogenicity study of chloral hydrate in male B6C3F1 mice.

Chloral hydrate, which is used as a sedative in pediatric medicine and is a by-product of water chlorination, is hepatocarcinogenic in B6C3F1 mice, a strain that can exhibit high rates of background liver tumor incidence, which are associated with increased body weight. In this study, dietary control was used to manipulate body growth in male B6C3F1 mice in a 2-year bioassay of chloral hydrate. Male B6C3F1 mice were treated with water or 25, 50, or 100 mg/kg chloral hydrate by gavage. The study compared ad libitum-fed mice with dietary controlled mice. The latter received variably restricted feed allocations to maintain their body weights on a predetermined "idealized" weight curve predictive of a terminal background liver tumor incidence of 15-20%. These mice exhibited less individual body weight variation than did their ad libitum-fed counterparts. This was associated with a decreased variation in liver to body weight ratios, which allowed the demonstration of a statistically significant dose response to chloral hydrate in the dietary controlled, but not the ad libitum-fed, test groups. Chloral hydrate increased terminally adjusted liver tumor incidence in both dietary controlled (23.4, 23.9, 29.7, and 38.6% for the four dose groups, respectively) and ad libitum-fed mice (33.4, 52.6, 50.6, and 46.2%), but a statistically significant dose response was observed only in the dietary controlled mice. This dose response positively correlated with markers of peroxisomal proliferation in the dietary controlled mice only. The study suggests that dietary control not only improves terminal survival and decreases interassay variation, but also can increase assay sensitivity by decreasing intra-assay variation.