A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections.

BACKGROUND: Despite significant advances in infection control guidelines and practices, surgical site infections (SSIs) remain a substantial cause of morbidity, prolonged hospitalization, and mortality among patients having both elective and emergent surgeries. D-PLEX100 is a novel, antibiotic-eluting polymer-lipid matrix that supplies a high, local concentration of doxycycline for the prevention of superficial and deep SSIs. The aim of our study was to evaluate the safety and efficacy of D-PLEX in addition to standard of care (SOC) in preventing superficial and deep surgical site infections for patients undergoing elective colorectal surgery. METHODS: From October 10, 2018 to October 6, 2019, as part of a Phase 2 clinical trial, we randomly assigned 202 patients who had scheduled elective colorectal surgery to receive either standard of care SSI prophylaxis or D-PLEX100 in addition to standard of care. The primary objective was to assess the efficacy of D-PLEX100 in superficial and deep SSI reduction, as measured by the incidence of SSIs within 30 days, as adjudicated by both an individual assessor and a three-person endpoint adjudication committee, all of whom were blinded to study-group assignments. Safety was assessed by the stratification and incidence of treatment-emergent adverse events. RESULTS: One hundred and seventy-nine patients were evaluated in the per protocol population, 88 in the intervention arm [51 males, 37 females, median age (64.0 range: 19-92) years] and 91 in the control arm [57 males, 34 females, median age 64.5 (range: 21-88) years]. The SSI rate within 30 day post-index surgery revealed a 64% relative risk reduction in SSI rate in the D-PLEX100 plus standard of care (SOC) group [n = 7/88 (8%)] vs SOC alone [n = 20/91 (22%)]; p = 0.0115. There was no significant difference in treatment-emergent adverse events. CONCLUSIONS: D-PLEX100 application leads to a statistically significant reduction in superficial and deep surgical site infections in this colorectal clinical model without any associated increase in adverse events.

Perioperative hyperglycemia: an unmet need within a surgical site infection bundle.

BACKGROUND: The aim of this study was to determine whether perioperative stress hyperglycemia is correlated with surgical site infection (SSI) rates in non-diabetes mellitus (DM) patients undergoing elective colorectal resections within an SSI bundle. METHODS: American College of Surgeons National Surgical Quality Improvement Program data of patients treated at a single institution in 2006-2012 were supplemented by institutional review board-approved chart review. A multifactorial SSI bundle was implemented in 2009 without changing the preoperative 8-h nil per os, and in the absence of either a carbohydrate loading strategy or hyperglycemic management protocol. Hyperglycemia was defined as blood glucose level > 140 mg/dL. The primary endpoint was SSI defined by the Centers for Disease Control National Nosocomial Infections Surveillance. RESULTS: Of 690 patients included, 112 (16.2%) had pre-existing DM. Overall SSI rates were significantly higher in DM patients as compared to non-DM patients (28.7 vs. 22.3%, p = 0.042). Postoperative hyperglycemia was more frequently seen in non-DM patients (46 vs. 42.9%). The SSI bundle reduced SSI rates (17 vs. 29.3%, p < 0.001), but the rate of hyperglycemia remained unchanged for DM or non-DM patients (pre-bundle 59%; post-bundle 62%, p = 0.527). Organ/space SSI rates were higher in patients with pre- and postoperative hyperglycemia (12.6%) (p = 0.017). Overall SSI rates were higher in DM patients with hyperglycemia as compared to non-DM patients with hyperglycemia (35.6 vs. 20.8%, p = 0.002). At multivariate analysis DM, chronic steroid use, chemotherapy and SSI bundle were predictive factors for SSI. CONCLUSIONS: This study showed that non-DM patients have a postoperative hyperglycemia rate as high as 46% in spite of the SSI bundle. A positive correlation was found between stress hyperglycemia and organ/space SSI rates regardless of the DM status. These data support the need for a strategy to prevent stress hyperglycemia in non-DM patients undergoing colorectal resections.

COMPRES: a prospective postmarketing evaluation of the compression anastomosis ring CAR 27(™) /ColonRing(™).

AIM: Preclinical studies have suggested that nitinol-based compression anastomosis might be a viable solution to anastomotic leak following low anterior resection. A prospective multicentre open label study was therefore designed to evaluate the performance of the ColonRing(™) in (low) colorectal anastomosis. METHOD: The primary outcome measure was anastomotic leakage. Patients were recruited at 13 different colorectal surgical units in Europe, the United States and Israel. Institutional review board approval was obtained. RESULTS: Between 21 March 2010 and 3 August 2011, 266 patients completed the study protocol. The overall anastomotic leakage rate was 5.3% for all anastomoses, including a rate of 3.1% for low anastomoses. Septic anastomotic complications occurred in 8.3% of all anastomoses and 8.2% of low anastomoses. CONCLUSION: Nitinol compression anastomosis is safe, effective and easy to use and may offer an advantage for low colorectal anastomosis. A prospective randomized trial comparing ColonRing(™) with conventional stapling is needed.

Cost of practice in a tertiary/quaternary referral center: is it sustainable?

BACKGROUND: Third-party payers are moving toward a bundled care payment system. This means that there will need to be a warranty cost of care-where the cost of complexity and complication rates is built into the bundled payment. The theoretical benefit of this system is that providers with lower complication rates will be able to provide care with lower warranty costs and lower overall costs. This may also result in referring riskier patients to tertiary or quaternary referral centers. Unless the payment model truly covers the higher cost of managing such referred cases, the economic risk may be unsustainable for these centers. METHODS: We took the last seven patients that were referred by other surgeons as "too high risk" for colectomy at other centers. A contribution margin was calculated using standard Medicare reimbursement rates at our institution and cost of care based on our administrative database. We then recalculated a contribution margin assuming a 3 % reduction in payment for a higher than average readmission rate, like that which will take effect in 2014. Finally, we took into account the cost of any readmissions. RESULTS: Seven patients with diagnosis related group (DRG) 330 were reviewed with an average age of 66.8 ± 16 years, American Society of Anesthesiologists score 2.3 ± 1.0, body mass index 31.6 ± 9.8 kg/m(2) (range 22-51 kg/m(2)). There was a 57 % readmission rate, 29 % reoperation rate, 10.8 ± 7.7 day average initial length of stay with 14 ± 8.6 day average readmission length of stay. Forty-two percent were discharged to a location other than home. Seventy-one percent of these patients had Medicare insurance. The case mix index was 2.45. Average reimbursement for DRG 330 was $17,084 (based on Medicare data) for our facility in 2012, with the national average being $12,520. The total contribution margin among all cases collectively was -$19,122 ± 13,285 (average per patient -$2,731, range -$21,905-$12,029). Assuming a 3 % reimbursement reduction made the overall contribution margin -$22,122 ± 13,285 (average -$3,244). Including the cost of readmission in the variable cost made the contribution margin -$115,741 ± 16,023 (average -$16,534). CONCLUSIONS: Care of high-risk patients at tertiary and quaternary referral centers is a very expensive proposition and can lead to financial ruin under the current reimbursement system.

Enhanced recovery protocol: implementation at a county institution with limited resources.

The benefits of an enhanced recovery protocol (ERP) in colorectal surgery have been well described; however, data on the implementation process is minimal, especially in a resource-limited institution. The purpose of this study was to evaluate outcomes during implementation of a physician-driven ERP at a public-funded institution. We retrospectively reviewed all elective colorectal surgery during a transition from standard care to an ERP (implemented via a standard order sheet). Data regarding use of care plan, length of stay (LOS), and rates of postoperative complications and readmission were recorded. One hundred eleven patients were included in the study; however, complete use of the ERP after its introduction occurred in a total of 50 patients for a compliance rate of 60 per cent (95% confidence interval [CI], 49 to 70). Late implementation of ERP diet, analgesics, and activity were the most common process errors. Full application of the ERP reduced mean LOS by 3 days (P=0.002), and there was a trend toward decreased postoperative morbidity without an increase in readmission rate (P=0.61). Full implementation of an ERP for colorectal surgery faces many challenges in a resource-limited county institution; however, when fully applied, the ERP safely reduced overall LOS, which is important in cost containment.

System-based factors influencing intraoperative decision-making in rectal cancer by surgeons: an international assessment.

AIM: Sound surgical judgement is the goal of training and experience; however, system-based factors may also colour selection of options by a surgeon. We analysed potential organizational characteristics that might influence rectal cancer decision-making by an experienced surgeon. METHOD: One hundred and seventy-three international centres treating rectal cancer were invited to participate in a survey assessment of key treatment options for patients undergoing curative rectal-cancer surgery. The key organizational characteristics were analysed using multivariate methods for association with intra-operative surgical decision-making. RESULTS: The response rate was 71% (123 centres). Sphincter-saving surgery was more likely to be performed at university hospitals (OR=3.63, P=0.01) and by high-caseload surgeons (OR=2.77 P=0.05). A diverting stoma was performed more frequently in departments with clinical audits (OR=3.06, P=0.02), and a diverting stoma with coloanal anastomosis was more likely in European centres (OR=4.14, P=0.004). One-stage surgery was less likely where there was assessment by a multidisciplinary team (OR=0.24, P=0.02). Multivariate analysis showed that university hospital, clinical audit, European centre, multidisciplinary team and high caseload significantly impacted on surgical decision-making. CONCLUSION: Treatment variance of rectal cancer surgeons appears to be significantly influenced by organizational characteristics and complex team-based decision-making. System-based factors may need to be considered as a source of outcome variation that may impact on quality metrics.

Assessment of comparative skills between hand-assisted and straight laparoscopic colorectal training on an augmented reality simulator.

PURPOSE: The aim of this study was to compare skills sets during a hand-assisted and straight laparoscopic colectomy on an augmented reality simulator. METHODS: Twenty-nine surgeons, assigned randomly in 2 groups, performed laparoscopic sigmoid colectomies on a simulator: group A (n = 15) performed hand-assisted then straight procedures; group B (n = 14) performed straight then hand-assisted procedures. Groups were compared according to prior laparoscopic colorectal experience, performance (time, instrument path length, and instrument velocity changes), technical skills, and operative error. RESULTS: Prior laparoscopic colorectal experience was similar in both groups. Both groups had better performances with the hand-assisted approach, although technical skill scores were similar between approaches. The error rate was higher with the hand-assisted approach in group A, but similar between both approaches in group B. CONCLUSIONS: These data define the metrics of performance for hand-assisted and straight laparoscopic colectomy on an augmented reality simulator. The improved scores with the hand-assisted approach suggest that with this simulator a hand-assisted model may be technically easier to perform, although it is associated with increased intraoperative errors.

Endogenous morphine levels after laparoscopic versus open colectomy.

BACKGROUND: Endogenous morphine may be a component of the acute-phase response to surgical trauma that affects both hospital stay and gastrointestinal motility. The purpose of this study was to assess the responses of endogenous morphine, stress hormones and cytokines following laparoscopic and open colectomy. METHODS: Twenty patients who underwent a laparoscopic colectomy were compared with ten who had an open procedure. Data collected included operative blood loss, operating time and time to pass flatus. Plasma endogenous morphine was measured before and immediately after operation, and 3, 24 and 48 h later. RESULTS: Age was comparable in the two groups. Operating time (mean 92.2 versus 61.3 min), time to tolerance of solid food (56.8 versus 103.6 h) and hospital stay (median 4 versus 6 days) were all significantly longer in the open group. Endogenous morphine levels rose immediately after open colectomy only and were higher than those after laparoscopic colectomy (8.69 versus 1.97 ng/ml; P < 0.001). Levels remained significantly higher than [corrected] in the laparoscopic group at 3 h (10.36 versus 0.52 ng/ml; P < 0.001) and 24 h, but were similar in both groups after 48 h. CONCLUSION: There is a greater degree of morphine synthesis after open than laparoscopic colectomy.

Fluid management for laparoscopic colectomy: a prospective, randomized assessment of goal-directed administration of balanced salt solution or hetastarch coupled with an enhanced recovery program.

INTRODUCTION: No consensus exists regarding the optimal fluid (crystalloid or colloid) or strategy (liberal, restricted, or goal directed) for fluid management after colectomy. Prior assessments have used normal saline. This is the first assessment of standard, goal-directed perioperative fluid management with either lactated Ringer's or hetastarch/lactated Ringer's, with use of esophageal Doppler for guidance, in laparoscopic colectomy with an enhanced recovery protocol. METHODS: A double-blinded, prospective, randomized, three-armed study with Institutional Review Board approval was used for patients undergoing laparoscopic segmental colectomy assigned to the standard, goal-directed/lactated Ringer's and goal-directed/hetastarch groups. A standard anesthesia and basal fluid administration protocol was used in addition to the goal-directed strategies guided by esophageal Doppler. RESULTS: Sixty-four patients undergoing laparoscopic colectomy (22 standard, 21 goal-directed/lactated Ringer's, 21 goal-directed/hetastarch) had similar operative times (standard, 2.3 hours; goal-directed/lactated Ringer's, 2.5 hours; goal-directed/hetastarch, 2.3 hours). The lactated Ringer's group received the greatest amount of total and milliliters per kilogram per hour of operative fluid (standard, 2,850/18; goal-directed/lactated Ringer's, 3,800/23; and goal-directed/hetastarch, 3,300/17; P < 0.05). The hetastarch group had the longest stay (standard, 64.9 hours; goal-directed/lactated Ringer's, 71.8 hours; goal-directed/hetastarch, 75.5 hours; P < 0.05). The standard group received the greatest amount of fluid during hospitalization (standard, 2.5 ml/kg/h; goal-directed/lactated Ringer's, 1.9 ml/kg/h; goal-directed/hetastarch, 2.1 ml/kg/h; P < 0.05). There was one instance of operative mortality in the goal-directed/hetastarch group. CONCLUSIONS: Goal-directed fluid management with a colloid/balanced salt solution offers no advantage and is more costly. However, goal-directed, individualized intraoperative fluid management with crystalloid should be evaluated further as a component of enhanced recovery protocols following colectomy because of reduced overall fluid administration.

Standardized algorithms for management of anastomotic leaks and related abdominal and pelvic abscesses after colorectal surgery.

BACKGROUND: The risk factors and incidence of anastomotic leak following colorectal surgery are well reported in the literature. However, the management of the multiple clinical scenarios that may be encountered has not been standardized. METHODS: The medical literature from 1973 to 2007 was reviewed using PubMed for papers relating to anastomotic leaks and abdominal abscess, with a specific emphasis on predisposing factors, prevention strategies, and treatment approaches. A six-round modified Delphi research method was utilized to find consensus among a group of expert colorectal surgeons and interventional radiologists regarding standardized management algorithms for anastomotic leaks. RESULTS: Management scenarios were divided into those for intraperitoneal anastomoses, extraperitoneal (low pelvic) anastomoses, and anastomoses with proximal diverting stomas. Management options were then based on the clinical presentation and radiographic findings and organized into three interconnected algorithms. CONCLUSIONS: This process was a useful first step toward establishing guidelines for the management of anastomotic leak.

Consensus conference on the stapled transanal rectal resection (STARR) for disordered defaecation.

An international working party was convened in Rome, Italy on 16-17 June, 2005, with the purpose of developing a consensus on the application of the circular stapling instrument to the treatment of certain rectal conditions, the so-called Stapled Transanal Rectal Resection (STARR). Since the procedure has been submitted to only limited objective analysis it was felt prudent to hold a meeting of interested individuals for the purpose of evaluating the current status and to make conclusions and recommendations concerning the applicability of this new approach.

Long-term outcome after laparoscopic and open surgery for rectal prolapse: a case-control study.

BACKGROUND: Laparoscopic repair (LR) of rectal prolapse is potentially associated with earlier recovery and lower perioperative morbidity, as compared with open transabdominal repair (OR). Data on the long-term recurrence rate and functional outcome are limited. METHODS: Perioperative data on rectal prolapse in relation to all LRs performed between December 1991 and April 2004 were prospectively collected. The LR patients were matched by age, gender, and procedure type with OR patients who underwent surgery during the same period. Patients with previous complex abdominal surgery or a body mass index exceeding 40 were excluded from the study. Data on recurrence rate, bowel habits, continence, and satisfaction scores were collected using a telephone survey. RESULTS: A total of 111 patients (age, 56.8 +/- 18.1 years; female, 87%) underwent attempted LR. An operative complication deferred repair in two cases. Among the 111 patients, 42 had posterior mesh fixation, and 67 had sutured rectopexy (32 patients with sigmoid colectomy for constipation). Eight patients (7.2%) had conversion to laparotomy. Matching was established for 86 patients. The LR patients had a shorter hospital stay (mean, 3.9 vs 6.0 days; p < 0.0001). The 30-day reoperation and readmission rates were similar for the two groups. The rates for recurrence requiring surgery were 9.3% for LR and 4.7% for OR (p = 0.39) during a mean follow-up period of 59 months. An additional seven patients in each group reported possible recurrence by telephone. Postoperatively, 35% of the LR patients and 53% of the OR patients experienced constipation (p = 0.09). Constipation was improved in 74% of the LR patients and 54% of the OR patients, and worsened, respectively, in 3% and 17% (p = 0.037). The postoperative incontinence rates were 30% for LR and 33% for OR (p = 0.83). Continence was improved in 48% of the LR patients and 35% of the OR patients, and worsened, respectively, in 9% and 18% (p = 0.22). The mean satisfaction rates for surgery (on a scale of 0 to 10) were 7.3 for the LR patients and 8.1 for the OR patients (p = 0.17). CONCLUSIONS: The hospital stay is shorter for LR than for OR. Both functional results and recurrent full-thickness rectal prolapse were similar for LR and OR during a mean follow-up period of 5 years.

Laparoscopic vs open total colectomy: a case-matched comparative study.

BACKGROUND: Open total colectomy and ileorectal anastomosis (OTC) is a major colorectal procedure which would preclude laparoscopy in many centers because of technical difficulty and the fact that laparoscopic total colectomy (LTC) takes much longer than standard laparoscopic proctosigmoidectomy (LPS). This study compares OTC with LTC and LPS. METHODS: In this study, 34 LTC patients (May 1999 to August 2003) were matched for age, diagnosis, operative period, and procedure with patients undergoing OTC. Patients with a previous major laparotomy were excluded from the open group. Groups were compared for gender, American Society of Anesthesiology (ASA) classification, operating time, estimated blood loss, length of hospital stay (LOS), complications including readmissions, and costs. The LPS cases were picked randomly from the laparoscopic database (every eighth patient), and the OT and LOS were noted. RESULTS: The LTC and OTC groups were matched for age (mean, 31 vs 34 years; p = 0.2), sex (14 vs 13 females; p = 0.8), ASA (8/23/3/0 vs 8/22/4/0, class 1/2/3/4). The body mass index was higher in the open group (23.8 vs 27.9; p = 0.04). The operating time was significantly longer (187 vs 126 min; p = 0.0001) and the median LOS shorter in the LTC group (3 days [IQR, 2.5-5 days] vs 6 days [IQR 4-8 days]; p = 0.0001). The estimated blood loss was significantly less in the LTC group (168 [50-700] ml) vs 238 [50-800] ml); p = 0.001, but there was no significant difference in the complication (26.5% vs 38.2%; p = 0.4) readmission (11.8% vs 14.7%; p = 1.0), reoperative rates (8.8% vs 11.8%; p = 1.0), or direct costs ($4,578 vs $4,562; p = 0.3). One LTC patient died expired on postoperative day 2 of a cardiac event. Four patients (11.8%) required conversion for obesity (n = 2), adhesions (n = 1), or intraoperative hemorrhage (n = 1). The operating times were 36 min longer in the LTC group than in the LPS group (151 vs 187 min; p = 0.02), but there was no significant difference in the LOS. (3 vs 3 days, p = 0.2). CONCLUSIONS: The findings show that LTC provides a significant decrease in the LOS over OTC, with increased operating time, but without any change in other parameters. A laparoscopic approach to subtotal colectomy is recommended for suitable patients when an experienced team is available.

Elective laparoscopic surgery for benign internal enteric fistulas: a review of 43 cases.

BACKGROUND: Laparoscopic surgery has been applied to the management of various colorectal conditions, with shorter recovery periods than reported for open surgery. This study reviewed the feasibility and outcome of laparoscopic surgery for benign internal enteric fistulas. METHODS: All the patients undergoing laparoscopic surgery for colovesical, colovaginal, enterovesical, and enterocolic fistulas caused by diverticulitis or Crohn's disease from 1995 to 2003 were identified from the prospective laparoscopic surgery database and retrospectively analyzed. Crohn's ileo-ileal fistulas were excluded from the study because these are generally resected more simply en bloc with the terminal ileum. RESULTS: This study enrolled 43 patients (23 men and 20 women) with median age of 43 years, a mean body mass index of 24.5, and in American Society of Anesthesiology (ASA) distribution of 3/33/8/0 (class 1/2/3/4). The diagnosis was diverticular for 24 patients and Crohn's disease for 19 patients. The mean operative time was 163 +/- 80 min (155 in completed and 180 in converted cases), and the mean length of hospital stay was 5.2 +/- 4.7 days (3.9 in completed and 7.9 days in converted cases). A total of 14 patients (32.6%) required conversion for dense adhesions (n = 8), duodenal involvement (n = 3), multiple fistulae (n = 1), fecal leak (n = 1), and additional pathology (n = 1). Conversion rates, analyzed by fistula type, were duodenal (100%), vaginal (66.7%), sigmoid (27.7%), bladder (15.4%), enterocolic (0%), and colocolic (0%). There were six major complications (14%) including anastomotic leak (n = 3), abscesses (n = 2), and postoperative bleeding (n = 1). There were seven minor complications (16.3%) including postoperative ileus (n = 2), transient pleural effusion (n = 1), wound infection (n = 1), transient small bowel obstruction (n = 2), and brachial plexus neuralgia (n = 1). There was no significant difference in the complication (p = 0.57), reoperation (p = 0.3), or readmission (p = 0.4) rates between the completed and converted cases. CONCLUSIONS: Laparoscopic surgery for benign internal enteric fistula offers the earlier recovery seen with other laparoscopic colorectal operations. Duodenal and vaginal involvement by the fistula is associated with a higher conversion rate. A low threshold toward early conversion is useful in these difficult cases to reduce delays in the operating room and the unnecessary use of hospital resources.

Conversion rates in laparoscopic colorectal surgery: a predictive model with, 1253 patients.

BACKGROUND: This study aimed all develop a mathematical model for predicting the conversion rate for patients undergoing laparoscopic colorectal surgery. METHOD: This descriptive single-center study used routinely collected clinical data from 1,253 patients undergoing laparoscopic surgery between November 1991 and April 2003. A two-level hierarchical regression model was used to identify patient, surgeon, and procedure-related factors associated with conversion of laparoscopic to open surgery. The model was internally validated and tested using measures of discrimination and calibration. Exclusion criteria for laparoscopic colectomy included a body mass greater than 50, lesion diameter exceeding 15 cm, and multiple prior major laparotomies (exclusive of appendectomy, hysterectomy, and cholecystectomy). RESULTS: The average conversion rate for the study population was 10.0% (95% confidence interval [CI], 8.3-11.7%). The independent predictors of conversion of laparoscopic to open surgery were the body mass index (odds ratio [OR], 2.1 per 10 Americans Society of Anesthesiology units increase), (ASA) grade 3 or 4, 1 or 2 (OR, 3.2, 5.8), type of resection (low rectal, left colorectal, right colonic vs small/other bowel procedures; OR, 8.82, 4.76, 2.98), presence of intraoperative abscess (OR, 3.60) or fistula (OR, 4.73), and surgeon seniority (junior vs senior staff OR, 1.56). The model offered adequate discrimination (area under receiver operator characteristic curve, 0.74) and excellent agreement (p = 0.384) between observed and model-predicted conversion rates (range of calibration, 3-32% conversion rate). CONCLUSIONS: Laparoscopic conversion rates are dependent on a multitude of factors that require appropriate adjustment for case mix before comparisons are made between or within centers. The Cleveland Clinic Foundation (CCF) laparoscopic conversion rate model is a simple additive score that can be used in everyday practice to evaluate outcomes for laparoscopic colorectal surgery.

Analysis of the outcome of ileal pouch-anal anastomosis in patients with Crohn's disease.

PURPOSE: Ileal pouch-anal anastomosis has come to represent the procedure of choice for patients requiring surgery for mucosal ulcerative colitis. In contrast, a proven diagnosis of Crohn's disease is generally held to preclude ileal pouch-anal anastomosis. However, patients with ileal pouch-anal anastomosis for apparent mucosal ulcerative colitis who are subsequently found to have Crohn's disease have a variable course. We reviewed our experience in this scenario to determine whether selected patients with Crohn's disease may be candidates for ileal pouch-anal anastomosis. METHODS: A retrospective review of the prospectively maintained ileal pouch-anal anastomosis database was undertaken to identify patients with a diagnosis of Crohn's disease after ileal pouch-anal anastomosis. Clinical outcome and quality-of-life data were obtained from the database and chart review. End points were the development of recrudescent Crohn's disease, pouch failure, and quality of life and functional outcome at the time of data collection. Differences between groups were calculated using the chi-squared test. Cumulative incidence of recrudescent Crohn's disease and pouch loss were calculated by the Kaplan-Meier method. Factors predictive of development of recrudescent Crohn's disease and pouch loss were examined by univariate analysis. RESULTS: Sixty patients (32 females; median age, 33 (range, 15-74) years) who underwent ileal pouch-anal anastomosis for mucosal ulcerative colitis subsequently had that diagnosis revised to Crohn's disease. Median follow-up of all patients was 46 (range, 4-158) months at time of data collection by which time 21 patients (35 percent) had developed recrudescent Crohn's disease. No pre-ileal pouch-anal anastomosis factors examined were predictors of the development of recrudescent Crohn's disease on univariate analysis. Median follow-up of the latter group was 63 (range, 0-132) months from time of diagnosis, by which time six patients underwent pouch excision and another patient was permanently defunctioned. The overall pouch loss rate for the entire cohort was 12 percent and 33 percent for those with recrudescent Crohn's disease. Median daily bowel movements in those with ileal pouch-anal anastomosis in situ at the time of data collection was 7 (range, 3-20), with 50 percent of patients rarely or never experiencing urgency and 59 percent reporting perfect or near perfect continence. Median quality of life, health, and happiness scores were 9.9 and 10 of 10. CONCLUSIONS: The secondary diagnosis of Crohn's disease after ileal pouch-anal anastomosis is associated with protracted freedom from clinically evident Crohn's disease, low pouch loss rate, and good functional outcome. Such results only can be improved by the continued development of medical strategies for the long-term suppression of Crohn's disease. These data support a prospective evaluation of ileal pouch-anal anastomosis in selected patients with Crohn's disease.

A prospective, randomized, controlled multicenter trial comparing stapled hemorrhoidopexy and Ferguson hemorrhoidectomy: perioperative and one-year results.

PURPOSE: There is a growing body of evidence supporting the lesser degrees of pain with stapled hemorrhoidopexy, also called the procedure for prolapse and hemorrhoids. However, there have been few randomized comparisons assessing both perioperative and long-term outcomes of the procedure for prolapse and hemorrhoids and Ferguson hemorrhoidectomy. Results are presented here from the first prospective, randomized, multicenter trial comparing these hemorrhoid procedures in the United States. METHODS: Patients with prolapsing hemorrhoids (Grade III) were randomized to undergo the procedure for prolapse and hemorrhoids or Ferguson hemorrhoidectomy by colorectal surgeons who had training in using the stapling technique. Primary end points were acute postoperative pain, and hemorrhoid symptom recurrence requiring additional treatment at one-year follow-up from surgery. RESULTS: A total of 156 patients (procedure for prolapse and hemorrhoids, 77; Ferguson, 79) completed randomization and the surgical procedure, 18 (procedure for prolapse and hemorrhoids, 12; Ferguson, 6) had significant protocol violations. One hundred seventeen patients (procedure for prolapse and hemorrhoids, 59; Ferguson, 58) returned for one-year follow-up. Demographic parameters, hemorrhoid symptoms, preoperative pain scores, and bowel habits were similar between groups. There were a similar number of patients with adverse events in each group (procedure for prolapse and hemorrhoids, 28 (36.4 percent) vs. Ferguson, 38 (48.1 percent); P = 0.138). Reoperation for an adverse effect was required in six (7.6 percent) Ferguson patients and in 0 patients having the procedure for prolapse and hemorrhoids (P = 0.028). Postoperative pain during the first 14 days, pain at first bowel movement, and need for postoperative analgesics were significantly less in the procedure for prolapse and hemorrhoids group. Control of hemorrhoid symptoms was similar between groups; however, significantly fewer patients having the procedure for prolapse and hemorrhoids required additional anorectal procedures during one-year follow-up (procedure for prolapse and hemorrhoids, 2 (2.6 percent), vs. Ferguson, 11 (13.9 percent); P = 0.01). Only four of the Ferguson patients (5 interventions) required additional procedures more than 30 days after surgery. CONCLUSIONS: These data demonstrate that stapled hemorrhoidopexy offers the benefits of less postoperative pain, less requirement for analgesics, and less pain at first bowel movement, while providing similar control of symptoms and need for additional hemorrhoid treatment at one-year follow-up from surgery.

Shorter hospital stay associated with fastrack postoperative care pathways and laparoscopic intestinal resection are not associated with increased physical activity.

OBJECTIVE: Recent prospective studies have shown that 'fast track' postoperative care protocols (FT) can reduce hospitalization after major intestinal surgery to 4.5 days, as compared to the 7-10 days with traditional management (TR) and 2.5 days after laparoscopic surgery (LC). We used computerized actigraphy (CA) to evaluate physical activity using TR, FT and LC approaches. METHODS: Fifteen patients undergoing intestinal resection by LC, TR and FT were recruited. CA devices were placed on the wrist and ankle of each patient from day 1 until hospital discharge. Intra-patient and intergroup analyses were performed using 24 h evaluations, and periods from 0800-2000 h. Results are presented for, level of activity (LOA; activity counts per minute), activity index (AI;% epochs with activity) and acceleration index (ACI; change in activity rate during analysis period) for 0800-2000 h. RESULTS: Levels of activity measured by wrist and ankle CA devices for the three different care protocols were: LC, 6263 +/- 8008 (wrist), 1640 +/- 3795 (ankle); FT 7874 +/- 8550 (wrist), 2153 +/- 4838 (ankle); LC 8526 +/- 9917 (wrist), 2326 +/- 4905 (ankle). Length of hospital stay was significantly shorter in LC than FT and TR patients (P < 0.01). There was no significant increase in wrist or ankle LOA for FT or LC patients. Similarly, there was no difference in AI or ACI. CONCLUSION: Although CA is an easily standardized method of evaluating physical activity after major abdominal surgery, no difference can be demonstrated between activity levels in patients managed by differing care pathways. Reductions in stay may be associated with factors other than a change in the level of physical activity after surgery.

Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy.

BACKGROUND: This randomized clinical trial compared the use of thoracic epidural anaesthesia-analgesia (TEA) with morphine patient-controlled analgesia (PCA) for pain relief after laparoscopic colectomy. METHODS: Patients scheduled for segmental laparoscopic colectomy were randomized to receive TEA or PCA. Patients in the TEA group received bupivacaine and fentanyl before incision and after surgery by continuous infusion for 18 h. Patients in the PCA group self-administered morphine using an intravenous pump. The postoperative care plan was otherwise identical for the two groups. Postoperative pain was measured during ambulation using a visual analogue pain score. RESULTS: The study included 38 patients (18 TEA, 20 PCA), 16 of whom underwent right hemicolectomy or ileocolectomy and 22 sigmoid colectomy. Operating times, patient weight and distribution of American Society of Anesthesiologists grade were similar in the two groups. The mean(s.e.m.) total dose of drugs administered was 64(41) mg morphine in the PCA group, and 79(42) mg bupivacaine and 205(140) micro g fentanyl in the TEA group. Postoperative pain scores were significantly better in the TEA group at 6 h (mean(s.e.m.) 2.2(0.4) versus 6.6(0.5) with PCA; P = 0.001) and 18 h (2.2(0.3) versus 4.0(0.4); P = 0.003). Hospital stay was similar in the two groups. CONCLUSION: TEA significantly improved early analgesia following laparoscopic colectomy but did not affect the length of hospital stay.

Evaluation of POSSUM and P-POSSUM scoring systems in assessing outcome after laparoscopic colectomy.

BACKGROUND: The purpose of this study was to compare the actual and predicted risk-adjusted morbidity and mortality after laparoscopic colectomy (LAC) calculated using both the Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) and Portsmouth POSSUM (P-POSSUM) scoring systems. METHODS: All patients who underwent LAC performed by a single surgeon between March 1999 and December 2000 were analysed. The observed morbidity and mortality rates were compared with those predicted by the POSSUM scoring system, and the observed mortality rate with that predicted by P-POSSUM. The operative severity component of the operative score was sequentially decreased from 4 (standard score for open colectomy) to 2, then 1, in an attempt to correct overprediction. RESULTS: Two hundred and fifty-one consecutive patients underwent LAC, with a conversion rate of 8.0 per cent. The morbidity rate (6.8 per cent) was significantly lower than the predicted rates calculated with an operative score of 4 or 2 (12.4 per cent, P < 0.001; 9.6 per cent, P = 0.001), but was fully corrected with an operative score of 1 (7.0 per cent, P = 0.325). The observed mortality rate (0.8 per cent) was significantly different from the expected mortality rates calculated using either uncorrected POSSUM (9.6 per cent, P = 0.001) or P-POSSUM (3.5 per cent, P = 0.001). POSSUM (2.6 per cent, P = 0.007) continued to overpredict mortality but P-POSSUM (1.0 per cent, P = 0.001) accurately predicted mortality with an operative score of 1. CONCLUSION: LAC appeared to be associated with lower morbidity and mortality rates than those predicted by the POSSUM scoring system, and with a lower mortality rate than that predicted using the P-POSSUM system.