Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection.

BACKGROUND: Indocyanine green fluoroscopy has been shown to improve anastomotic leak rates in early phase trials. OBJECTIVE: We hypothesized that the use of fluoroscopy to ensure anastomotic perfusion may decrease anastomotic leak after low anterior resection. DESIGN: We performed a 1:1 randomized controlled parallel study. Recruitment of 450 to 1000 patients was planned over 2 years. SETTINGS: This was a multicenter trial. PATIENTS: Included patients were those undergoing resection defined as anastomosis within 10 cm of the anal verge. INTERVENTION: Patients underwent standard evaluation of tissue perfusion versus standard in conjunction with perfusion evaluation using indocyanine green fluoroscopy. MAIN OUTCOME MEASURES: Primary outcome was anastomotic leak, with secondary outcomes of perfusion assessment and the rate of postoperative abscess requiring intervention. RESULTS: This study was concluded early because of decreasing accrual rates. A total of 25 centers recruited 347 patients, of whom 178 were randomly assigned to perfusion and 169 to standard. The groups had comparable tumor-specific and patient-specific demographics. Neoadjuvant chemoradiation was performed in 63.5% of perfusion and 65.7% of standard (p > 0.05). Mean level of anastomosis was 5.2 ± 3.1 cm in perfusion compared with 5.2 ± 3.3 cm in standard (p > 0.05). Sufficient visualization of perfusion was reported in 95.4% of patients in the perfusion group. Postoperative abscess requiring surgical management was reported in 5.7% of perfusion and 4.2% of standard (p = 0.75). Anastomotic leak was reported in 9.0% of perfusion compared with 9.6% of standard (p = 0.37). On multivariate regression analysis, there was no difference in anastomotic leak rates between perfusion and standard (OR = 0.845 (95% CI, 0.375-1.905); p = 0.34). LIMITATIONS: The predetermined sample size to adequately reduce the risk of type II error was not achieved. CONCLUSIONS: Successful visualization of perfusion can be achieved with indocyanine green fluoroscopy. However, no difference in anastomotic leak rates was observed between patients who underwent perfusion assessment versus standard surgical technique. In experienced hands, the addition of routine indocyanine green fluoroscopy to standard practice adds no evident clinical benefit. See Video Abstract at http://links.lww.com/DCR/B560. VALORACIN DE LA IRRIGACIN DE LADO IZQUIERDO/RESECCIN ANTERIOR BAJA PILAR III UN ESTUDIO ALEATORIZADO, CONTROLADO, PARALELO Y MULTICNTRICO QUE EVALA LOS RESULTADOS DE LA IRRIGACIN CON PINPOINT IMGENES DE FLUORESCENCIA CERCANA AL INFRARROJO EN LA RESECCIN ANTERIOR BAJA: ANTECEDENTES:Se ha demostrado que la fluoroscopia con verde de indocianina mejora las tasas de fuga anastomótica en ensayos en fases iniciales.OBJETIVO:Nuestra hipótesis es que la utilización de fluoroscopia para asegurar la irrigación anastomótica puede disminuir la fuga anastomótica luego de una resección anterior baja.DISEÑO:Realizamos un estudio paralelo, controlado, aleatorizado 1:1. Se planificó el reclutamiento de 450-1000 pacientes durante 2 años.AMBITO:Multicéntrico.PACIENTES:Pacientes sometidos a resección definida como una anastomosis dentro de los 10cm del margen anal.INTERVENCIÓN:Pacientes que se sometieron a la evaluación estándar de la irrigación tisular contra la estándar en conjunto con la valoración de la irrigación mediante fluoroscopia con verde indocianina.PRINCIPALES VARIABLES EVALUADAS:El principal resultado fue la fuga anastomótica, y los resultados secundarios fueron la evaluación de la perfusión y la tasa de absceso posoperatorio que requirió intervención.RESULTADOS:Este estudio se cerró anticipadamente debido a la disminución de las tasas de acumulación. Un total de 25 centros reclutaron a 347 pacientes, de los cuales 178 fueron, de manera aleatoria, asignados a perfusión y 169 a estándar. Los grupos tenían datos demográficos específicos del tumor y del paciente similares. Recibieron quimio-radioterapia neoadyuvante el 63,5% de la perfusión y el 65,7% del estándar (p> 0,05). La anastomosis estuvo en un nivel promedio de 5,2 + 3,1 cm en perfusión en comparación con 5,2 + 3,3 cm en estándar (p> 0,05). Se reportó una visualización suficiente de la perfusión en el 95,4% de los pacientes del grupo de perfusión. El absceso posoperatorio que requirió tratamiento quirúrgico fue de 5,7% de los perfusion y en el 4,2% del estándar (p = 0,75). Se informó fuga anastomótica en el 9,0% de la perfusión en comparación con el 9,6% del estándar (p = 0,37). En el análisis de regresión multivariante, no hubo diferencias en las tasas de fuga anastomótica entre la perfusión y el estándar (OR 0,845; IC del 95% (0,375; 1,905); p = 0,34).LIMITACIONES:No se logró el tamaño de muestra predeterminado para reducir satisfactoriamente el riesgo de error tipo II.CONCLUSIÓN:Se puede obtener una visualización adecuada de la perfusión con ICG-F. Sin embargo, no se observaron diferencias en las tasas de fuga anastomótica entre los pacientes que se sometieron a evaluación de la perfusión versus la técnica quirúrgica estándar. En manos expertas, agregar ICG-F a la rutina de la práctica estándar no agrega ningún beneficio clínico evidente. Consulte Video Resumen en http://links.lww.com/DCR/B560. (Traducción-Dr Juan Antonio Villanueva-Herrero).

Diverted versus undiverted restorative proctocolectomy for chronic ulcerative colitis: an analysis of long-term outcomes after pouch leak short title: outcomes after pouch leak.

BACKGROUND: The safety of undiverted restorative proctocolectomy (RPC) is debated. This study compares long-term outcomes after pouch leak in diverted and undiverted RPC patients. METHODS: Data were obtained from a prospectively maintained registry from a single surgical practice. One-stage and staged procedures with an undiverted pouch were considered undiverted pouches; all others were considered diverted pouches. The outcomes measured were pouch excision and long-term diversion defined as the need for loop ileostomy at 200 weeks after pouch creation. Regression models were used to compare outcomes. RESULTS: There were 317 diverted and 670 undiverted pouches, of which 378 were one-stage procedures. Pouch leaks occurred in 135 patients, 92 (13.7%) after undiverted, and 43 (13.6%) after diverted pouches. Eighty-six (64%) leaks were diagnosed within 6 months of pouch creation. Undiverted patients underwent more emergent procedures within 30 days of pouch creation (p < 0.01). Pouch excision occurred in 14 (33%) diverted patients and 13 (14%) undiverted patients (p = 0.01). Thirteen (32%) diverted patients and 18 (21%) undiverted patients (p = 0.17) had ileostomies at 200 weeks after surgery. In multivariable analyses, diverted patients had a higher risk of pouch excision (HR 3.67 p < 0.01), but similar rates of ileostomy at 200 weeks (HR 1.8, p = 0.19) compared to undiverted patients. CONCLUSIONS: Despite a likely selection bias in which "healthier" patients undergo an undiverted pouch, our data suggest that diversion does not prevent pouch excision and the need for long-term diversion after pouch leak. These findings suggest that undiverted RPC is a safe procedure in appropriately selected patients.

Assessment of Bowel End Perfusion After Mesenteric Division: Eye Versus SPY.

BACKGROUND: Anastomotic complications related to tissue ischemia cause morbidity in gastrointestinal (GI) surgery. Surgeons' standard practice to predict bowel perfusion is inspection of mesenteric perfusion before anastomosing bowel ends. Augmenting this assessment with fluorescent imaging is under study. A standardized system to evaluate this imaging has not yet been developed. This study compared the surgeon's intraoperative assessment to a novel GI-specific imaging analysis method. MATERIALS AND METHODS: Forty-nine consecutive patients undergoing open or laparoscopic-assisted bowel resections were enrolled. After mesenteric division, the surgeon marked the site for bowel transection. Near-infrared fluorescence imaging was performed on the marked bowel ends. Imaging analysis identified theoretical transection sites based on the quantification of arterial and microvascular inflow (Perfusion) and venous outflow (Timing). The primary outcome was the measured disparity between the site marked by the surgeon using current standard of care parameters and the imaging-determined site. No clinical outcomes were assessed. RESULTS: Seventy-two bowel end segments from 46 patients were analyzed. Disparity was found in 11 of 72 (15%) bowel end segments. In five (7%), the disparity was due to either Perfusion or Timing (single), and in six (8%), due to both Perfusion and Timing (combined). In the single disparity group, the median disparity distance was 2.0 cm by Perfusion and 4.0 cm by Timing, and in the combined group, 3.8 cm by Perfusion and 3.5 cm by Timing. Disparity (either single or combined) was in 25% of colon and 11.5% of small bowel (P = NS). Combined and single disparity had equivalent lengths of disparity distance (P = NS). CONCLUSIONS: Imaging coupled with this GI-specific analysis provides objective, real-time, and interpretable data of intramural blood supply. A 15% disparity rate from current clinical practice was observed.

Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study.

OBJECTIVE: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. BACKGROUND: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. METHODS: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests. RESULTS: Patients had a mean age of 58 years, body mass index of 28 kg/m, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ≤ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05). CONCLUSIONS: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

Fistula-Associated Anorectal Cancer in the Setting of Crohn's Disease.

BACKGROUND: Cancer arising from perianal fistulas in patients with Crohn's disease is rare. There are only a small series of articles that describe sporadic cases of perianal cancer in Crohn's disease fistulas. Therefore, there are no clear guidelines on how to appropriately screen patients at risk and choose proper management. OBJECTIVE: The purpose of this study was to describe patients diagnosed with cancer in perianal fistulas in the setting of Crohn's disease. DESIGN: The study involved an institutional review board-approved retrospective review of medical charts of patients with perianal Crohn's disease. The data extracted from patient charts included demographic and clinical characteristics. SETTINGS: Patients seen at the Mount Sinai Medical Center were included. PATIENTS: We identified patients who were diagnosed with perianal cancer in biopsies of fistula tracts. MAIN OUTCOME MEASURES: We observed the number of patients with Crohn's disease who had fistulas, cancer in fistula tract, and time to diagnosis. RESULTS: The charts of 2382 patients with fistulizing perianal Crohn's disease were reviewed. Cancer in a fistula tract was diagnosed in 19 (0.79%) of these patients, 9 with squamous-cell carcinoma and 10 with adenocarcinoma. The majority of the 19 patients (68%) had symptoms typical of perianal fistula. The mean time from diagnosis of Crohn's disease to fistula diagnosis and from fistula diagnosis to cancer diagnosis was 19.4 and 6.0 years. In 5 patients (26%), cancer was not diagnosed in the first biopsy obtained from the fistula tract. LIMITATIONS: This is a retrospective chart review of a rare outcome; the results may not be generalizable. CONCLUSIONS: Routine biopsies of long-standing fistula tracts in patients with Crohn's disease should be strongly considered and may yield an earlier diagnosis of cancer in the fistula tracts.

High rates of metachronous colon cancer or dysplasia after segmental resection or subtotal colectomy in Crohn's colitis.

BACKGROUND: In ulcerative colitis, total proctocolectomy is the treatment of choice for patients with colonic dysplasia or cancer because of the high risk for metachronous neoplasia. It is unknown whether patients with Crohn's disease and colon cancer or dysplasia have a similar risk. METHODS: We retrospectively reviewed the charts of 75 patients treated at our center from 2001 to 2011 with Crohn's disease and colon cancer who underwent segmental resection or subtotal colectomy (STC). We then identified the presence or absence of subsequent colon cancer or dysplasia in these patients during the follow-up (0-19 years). RESULTS: Of the 64 patients with colon cancer, 25 had at least 1 metachronous cancer (39%). The mean time to a new cancer was 6.8 years. Eighty-five percent of patients (21/25) were undergoing annual screening colonoscopy. Of the 11 patients with dysplasia, 5 (46%) had a new dysplasia. Mean time to a new dysplastic lesion was 5.0 years. Nineteen of the 47 patients (40%) who had a segmental resection for colon cancer developed metachronous cancer and 6/17 patients (35%) with a STC had metachronous cancer. Two of the 4 patients (50%) with STC for dysplasia (50%) had a new dysplasia and 3/7 patients (43%) with segmental resection had a new dysplasia. There was no significant difference (P = 0.61) between recurrence rates in patients with segmental resection versus STC. CONCLUSIONS: The high rate of metachronous colon cancer after surgical resection suggests that total proctocolectomy should be considered. Larger studies are required to determine if the same is true for dysplasia.

Immunosuppressive therapy does not increase operative morbidity in patients with Crohn's disease.

GOALS: The aim of this study was to examine the impact of immunosuppressive therapy on the morbidity of intestinal surgery in patients with Crohn's disease. BACKGROUND: An increasing number of immunomodulating agents are being used in the treatment of Crohn's disease. The effect of these medications on surgical morbidity is controversial. STUDY: We performed a retrospective review of our prospectively maintained database of patients with Crohn's disease who underwent intestinal surgery between June 1999 and May 2010. The effect of perioperative immunomodulation on postoperative outcomes, specifically anastomotic complications, was evaluated. Predictors of postoperative morbidity among demographic and surgical variables were identified. Length of hospitalization and rate of hospital readmission were compared between groups. Comparisons were made using Student t test and Fisher exact test. RESULTS: One hundred ninety-six intestinal procedures were performed. One hundred twenty-seven (64.8%) of these were performed among patients who received perioperative immunomodulation. Forty-six (23.5%) procedures were in patients who received >1 immunomodulating medication perioperatively. Complications occurred in 45 (23.0%) cases. There were 20 (10.2%) anastomotic complications, including 8 (4.1%) intra-abdominal abscesses, 8 (4.1%) anastomotic leaks, and 4 (2%) enterocutaneous fistulas. Preoperative treatment with steroids (P=0.21), 6-MP (P=0.10), and anti-tumor necrosis factor biologics (P=1.0) was not associated with increased postoperative anastomotic complications. Combination immunosuppressive therapy also did not increase morbidity (P=0.39). CONCLUSIONS: In our series, single agent and combination immunosuppressive therapy given around the time of intestinal surgery did not increase the incidence of surgical complications in patients with Crohn's disease.

The clinical impact of preoperative percutaneous drainage of abdominopelvic abscesses in patients with Crohn's disease.

PURPOSE: Although image-guided percutaneous drainage is increasingly being used to treat Crohn's disease-related abdominopelvic abscesses, surgery is seldom avoided. The aim of this study was to compare outcomes following the treatment of intra-abdominal Crohn's abscesses with percutaneous drainage followed by surgery to those after surgery alone. METHODS: We retrospectively reviewed the charts of patients treated for Crohn's-related abdominopelvic abscesses at Mount Sinai Medical Center between April 2001 and June 2010. Patients who underwent drainage followed by surgery were compared to those who underwent surgery alone. Differences in operative and postoperative outcomes were compared. RESULTS: Seventy patients with Crohn's disease-related abdominopelvic abscesses were identified, 38 (54%) of whom underwent drainage before surgery. Percutaneous drainage was technically successful in 92% of patients and clinically successful in 74% of patients. No differences in rate of septic complications (p = 0.14) or need for stoma creation (p = 0.78) were found. Patients who underwent percutaneous drainage had greater overall hospital lengths of stay (mean 15.8 versus 12.2 days, p = 0.007); 8.6% of patients had long-term postponement of surgery after percutaneous drainage. CONCLUSIONS: In our series, the treatment of Crohn's abscesses with percutaneous drainage prior to surgery did not decrease the rate of postoperative septic complications.

Small bowel adenocarcinoma in Crohn's disease.

BACKGROUND: An association between small bowel adenocarcinoma and Crohn's disease (CD) is well-established. We present our recent experience with this entity in order to further elucidate its clinicopathological features and update our series from 1991. METHODS: A retrospective review was undertaken of all surgical patients with small bowel adenocarcinoma and CD seen at our institution between 1993 and 2009. Follow-up was assessed until time of death or by interview with survivors. Survival was calculated based on TNM (tumor extent, lymph node status, metastases staging) staging and comparing between our current and previous series. RESULTS: Twenty-nine patients (ten females and 19 males) were identified and followed for a median of 2 years. The median age at onset of CD symptoms was 25, and the median age at cancer diagnosis was 55.4, for a mean interval of 25.3 years. Twenty-two cancers were ileal and five were jejunal. There were no cancers in excluded intestinal loops. Significant differences in 2-year survival were determined for: node-negative (79.3%, 95%CI 58.3-100%) versus node-positive cancers (49% %, 95%CI 20.0-78.0%), and for localized (92.3%, 95%CI 77.8-100%) versus metastatic disease (33.3%, 95%CI 6.6-60%). Overall 36-month survival was 69.3% (95%CI 51.5-87.1%) compared to 40% among those without excluded loops in our series from 1991. Sixteen patients had long periods of quiescent disease before diagnosis (7-45 years), and 16 required surgery for bowel obstruction that was refractory to medical management. Adequate information was not retrievable for three patients. CONCLUSIONS: A comparison to our previous series reveals similar clinical characteristics and a high rate of node-positive cancer at diagnosis. Our findings also confirm two important clinical indicators of malignancy: recrudescent symptoms after long periods of relative quiescence and small bowel obstruction that is refractory to medical therapy.

Evaluation of one-stage laparoscopic-assisted restorative proctocolectomy at a specialty center: comparison with the open approach.

PURPOSE: This study compared outcomes after laparoscopically assisted and open restorative proctocolectomy performed as a one-stage procedure, including anorectal mucosectomy and omission of ileal diversion. METHODS: We reviewed our prospectively maintained database of patients who underwent restorative proctocolectomy between 1998 and 2006. Demographic data, surgical indications, and intraoperative and postoperative complications were evaluated. Anastomotic leaks were identified by radiologic, endoscopic, or intraoperative evidence. The primary outcome variables were complications, duration of operation, blood loss, intraoperative spillage of enteric contents, and the ability to complete the procedure in one stage. RESULTS: One-stage laparoscopically assisted restorative proctocolectomy was performed in 50 patients and open restorative proctocolectomy was performed in 155 patients. The mean operative time was longer for the laparoscopically assisted group (198.7 vs. 159.1 minutes; P = 0.006). The mean estimated blood loss was less among the patients in the laparoscopically assisted group (287.5 vs. 386.4 ml; P = 0.006). There were no significant differences in intraoperative or postoperative complications between the two groups. CONCLUSIONS: Laparoscopically assisted one stage restorative proctocolectomy is a safe and technically feasible procedure. There seems to be no increase in the rate of postoperative complications compared with the open approach. Laparoscopically assisted restorative proctocolectomy should be considered in the surgical management of patients who require this procedure.

Recurrence patterns after first resection for stricturing or penetrating Crohn's disease.

BACKGROUND: Crohn's disease (CD) usually recurs after resection, but the factors associated with this risk remain obscure. We set out to determine the role of stricturing (Montreal Classification B2) versus penetrating (Classification B3) disease behavior in predicting early (<3 years) versus late (>or=3 years) postoperative recurrence. METHODS: We identified a cohort of 34 patients seen at The Mount Sinai Hospital who had undergone a first ileocolic resection prior to December 31, 2004, who had been clinically thought to have had stricturing (B2) disease, and for whom we could verify 1) the operative and surgical pathology findings; and 2) the time of onset of symptoms attributable to recurrent CD by endoscopy, radiology, or surgery. Cases were reclassified as either "stricturing" (B2) or "penetrating" (B3) on the basis of operative and surgical pathology reports. Recurrences were classified as either "early" (<3 years) or "late" (>or=3 years) depending on the first appearance of postoperative symptoms that were verified endoscopically and histologically, radiologically, or surgically as being attributable to anastomotic recurrence of the CD. RESULTS: Among these 34 patients clinically thought to have had B2 disease, 12 had B2 disease confirmed upon review of surgical and pathology reports and none of them had recurrence within 3 years. Among the 22 patients reclassified as B3 disease, 12 (55%) had early recurrence. This difference was significant at the 0.002 level by the Fisher Exact Test. CONCLUSIONS: There is a strong proclivity for early postoperative recurrence of penetrating CD compared to stricturing disease, which may not be evident by behavioral classification on clinical grounds alone. Patients with confirmed uncomplicated stricturing obstruction at their first resection seem unlikely to experience a clinical recurrence within the next 3 years.

Colorectal carcinoma in indeterminate colitis.

BACKGROUND: For all the interest in the natural history of colorectal cancer (CRC) in ulcerative colitis (UC) and Crohn's disease (CD), surprisingly few data have been published regarding CRC in indeterminate colitis (IC). We present our experience with 15 cases of IC-associated CRC in order to assess their clinicopathological features and to determine their survival rates. METHODS: We retrospectively reviewed the medical records of patients with IC admitted to the Mount Sinai Hospital between 1994 and 2007 and who developed CRC. All patients were operated on and follow-up was complete for all patients to the closing date of study or to the time of death. RESULTS: A total of 19 adenocarcinomas were present in this series. There were 3 patients with multiple cancers; all cancers occurred in segments of colitis. The mean age at onset of IC was 28 years and the average time progression from the IC diagnosis to CRC was 19 years. Dysplasia was detected in 10 of the cases; 3 patients had mucinous tumors. Five patients had stage I tumors; 5 stage II; 4 stage III; 1 stage IV. There were 4 deaths due to CRC. The overall 5-year survival was 42%. CONCLUSIONS: CRC in IC shares most of the clinical and pathologic features as well as survival outcomes with CRC that occurs in the most prevalent forms of inflammatory bowel disease (IBD), UC and CD. Surveillance regimens currently used in the other forms of IBD seem applicable to IC patients as well.

Septic complications after restorative proctocolectomy do not impair functional outcome: long-term follow-up from a specialty center.

PURPOSE: After restorative proctocolectomy, 7 to 8 percent of patients may have a pouch leak. Concern exists that pouch leak may be associated with impaired functional outcome. We evaluated patients who underwent restorative proctocolectomy to determine whether pouch leak adversely affected long-term functional outcome and quality of life. METHODS: We queried our prospectively maintained database of patients who underwent restorative proctocolectomy for demographic and clinical data. We sent a long-term outcome questionnaire to patients, including the validated Fecal Incontinence Severity Index and Cleveland Global Quality of Life scores. Pouch leak was identified by clinical or radiographic evidence of leak. Patients with leak were compared with those without to determine the impact on long-term functional outcome or quality of life. RESULTS: A total of 817 patients were available for follow-up and 374 patients (46 percent) completed questionnaires. The group with (n = 60; 16 percent) and without (n = 314; 84 percent) leak had similar demographics. The median Fecal Incontinence Severity Index score (15.3 vs. 14.7, P = 0.77), Cleveland Global Quality of Life score (0.79 vs. 0.81, P = 0.48), and bowel movements per 24 hours (7.92 vs. 7.88, P = 0.92) were similar. The pouch loss/permanent ileostomy rate was higher in those who leaked (13.3 vs. 0.9 percent, P < 0.001). CONCLUSIONS: Anastomotic leak after restorative proctocolectomy does not adversely affect long-term quality of life or functional outcome. However, pouch loss/permanent ileostomy is significantly more likely in patients who have had an anastomotic leak.

Delayed Kock pouch nipple valve failure: is revision indicated?

PURPOSE: This study was designed to review our experience with patients who, after more than 10 years of normal Kock pouch valve function, required repair of the valve. In addition, we describe the surgical techniques employed for valve repair. METHODS: A retrospective chart review identified 31 patients who underwent Kock pouch revision after a minimum time interval between previous pouch surgery and the current revision of 10 (average, 19.7) years. RESULTS: The intraoperative findings included slipped valve, valve prolapse, and internal nipple valve fistulas. The procedures performed included standard valve reconstruction, turnaround procedures, pedicle repair, wall stapling, and oversewing of fistula. Twelve of the 31 patients failed the initial revision and required additional operations, with an overall pouch salvage success rate of 93 percent. Only two patients required excision of the pouch and conversion to a Brooke ileostomy. The procedures were performed with minimal morbidity and no mortality. CONCLUSION: Surgical revision can be offered to patients with a continent ileostomy complicated by delayed valve dysfunction with low morbidity and good functional outcome.

Laparoscopic-assisted ileocolic resection for Crohn's disease.

BACKGROUND: This study reviews our experience with laparoscopic-assisted ileocolic resection in patients with Crohn's disease. The adequacy and safety of this procedure as measured by intraoperative and postoperative complications were evaluated. Special attention was paid to the group in which laparoscopy was not feasible and conversion to laparotomy was necessary. METHODS: Between 1992 and 2005, 168 laparoscopic-assisted ileocolic resections were performed on 167 patients with Crohn's ileal or ileocolic disease. Follow-up data were complete in 158 patients. RESULTS: In 38 patients (24%), conversion to laparotomy was necessary. Previous resection was not a predictor of conversion to laparotomy. Average ileal and colonic length of resected specimens was 20.9 cm and 6.5 cm, respectively, in the laparoscopic group, versus 24.9 cm and 10.6 cm in the converted group. Twenty of 120 specimens (16.6%) in the laparoscopic group were found to have margins microscopically positive for active Crohn's disease. None of the 38 specimens in the converted group had positive ileal margins. CONCLUSIONS: Laparoscopic-assisted ileocolic resection can be safely performed in patients with Crohn's disease ileitis. The finding of positive surgical margins following laparoscopic resections compared with none among conventional resections has to be thoroughly evaluated.

Alvimopan accelerates gastrointestinal recovery after bowel resection regardless of age, gender, race, or concomitant medication use.

BACKGROUND: Postoperative ileus is a transient cessation of bowel motility that occurs after bowel resection (BR). Alvimopan, a peripherally acting mu-opioid receptor antagonist accelerated gastrointestinal (GI) recovery in 5 randomized, double-blind, phase III postoperative ileus trials. METHODS: Individual covariates (age, gender, race) were assessed separately using Cox proportional hazards models that included the main effects of treatment and covariate factor. Time-to-GI recovery (GI-3 [first toleration of solid food and first bowel movement or flatus]; GI-2 [first toleration of solid food and first bowel movement]) for patients who underwent open laparotomy for BR in the absence of epidural anesthesia and received alvimopan (12 mg) or placebo was analyzed within subgroups (age, gender, race, concomitant medication use) using Cox proportional hazards models to generate hazard ratios (HRs). P values were calculated with the Wald chi2 test. RESULTS: Elderly (>or=65 years), male, and nonwhite patients achieved GI-3 recovery later than younger (<65 years), female, and white patients (HR > 1 and P < .05 for all). Overall, alvimopan (12 mg) accelerated GI-3 recovery by 12 hours and GI-2 recovery by 17 hours compared with placebo. Within subgroups, regardless of covariate effect, patients who received alvimopan (12 mg) achieved GI-2 and GI-3 recovery sooner than patients who received placebo (HR > 1 and P < .05 for all). CONCLUSIONS: These post hoc analyses support that alvimopan (12 mg) accelerates GI recovery across various patient populations.

Mucosal dysplasia in ileal pelvic pouches after restorative proctocolectomy.

PURPOSE: Inflammation, villous atrophy, colonic metaplasia, and dysplasia have been observed within the mucosa of ileal pelvic pouches after restorative proctocolectomy. This study was designed to determine the prevalence of mucosal dysplasia in ileal pouch and any associated risk factors. METHODS: Prospectively registered patients having restorative proctocolectomy were recruited. A cross-sectional study was performed using a questionnaire focusing on disease history, functional results, and pouchitis after surgery. Participants underwent screening endoscopic pouch examination using sigmoidoscopy. Mucosal biopsies were taken from six specific locations in the pouch from proximal ileal-pouch (inflow) to ileoanal anastomosis. All biopsies were performed under strict surveillance protocol regardless of patients' symptoms. Biopsies were interpreted by two pathologists unaware of each other's report. RESULTS: A total of 138 patients completed the protocol. Colectomy specimens from restorative proctocolectomy showed chronic ulcerative colitis in 118 (85.6 percent), familial adenomatous polyposis in 10 (7.2 percent), Crohn's colitis in 2 (1.4 percent), and indeterminate colitis in 8 (5.8 percent) patients. Twenty-two patients (18.3 percent) had dysplasia and eight (6.7 percent) had invasive cancer found in colectomy specimens after restorative proctocolectomy. Median interval between proctocolectomy and pouch biopsy was 5.4 years. Inflammatory changes were present in a majority of specimens, but these did not correlate with clinical history of pouchitis. No villous atrophy was identified. Pouch biopsies from only one patient were indefinite for dysplasia. Subsequent biopsies were negative. CONCLUSIONS: Clinical and microscopic evidence of ileal-pouch inflammation is common. Ileal-pouch mucosal dysplasia is uncommon, occurring in only 1 of 138 patients. Villous atrophy and colonic metaplasia were not observed in this series. Routine pouch surveillance with biopsies may not be warranted.

Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.

INTRODUCTION: Although Seprafilm has been demonstrated to reduce adhesion formation, it is not known whether its usage would translate into a reduction in adhesive small-bowel obstruction. METHODS: This was a prospective, randomized, multicenter, multinational, single-blind, controlled study. This report focuses on those patients who underwent intestinal resection (n = 1,701). Before closure of the abdomen, patients were randomized to receive Seprafilm or no treatment. Seprafilm was applied to adhesiogenic tissues throughout the abdomen. The incidence and type of bowel obstruction was compared between the two groups. Time to first adhesive small-bowel obstruction was compared during the course of the study by using survival analysis methods. The mean follow-up time for the occurrence of adhesive small-bowel obstruction was 3.5 years. RESULTS: There was no difference between the treatment and control group in overall rate of bowel obstruction. The incidence of adhesive small-bowel obstruction requiring reoperation was significantly lower for Seprafilm patients compared with no-treatment patients: 1.8 vs. 3.4 percent (P < 0.05). This finding represents an absolute reduction in adhesive small-bowel obstruction requiring reoperation of 1.6 percent and a relative reduction of 47 percent. In addition, a stepwise multivariate analysis indicated that the use of Seprafilm was the only predictive factor for reducing adhesive small-bowel obstruction requiring reoperation. In both groups, 50 percent of first adhesive small-bowel obstruction episodes occurred within 6 months after the initial surgery with nearly 30 percent occurring within the first 30 days. Additionally no first adhesive small-bowel obstruction events were reported in Years 4 and 5 of follow-up. CONCLUSIONS: The overall bowel obstruction rate was unchanged; however, adhesive small-bowel obstruction requiring reoperation was significantly reduced by the use of Seprafilm, which was the only factor that predicted this outcome.