Peter A. Cataldo

Anastomotic Leaks After Intestinal Anastomosis: It's Later Than You Think

Purpose:Anastomotic leaks are among the most dreaded complications after colorectal surgery. However, problems with definitions and the retrospective nature of previous analyses have been major limitations. We sought to use a prospective database to define the true incidence and presentation of anastomotic leakage after intestinal anastomosis. Methods:A prospective database of two colorectal surgeons was reviewed over a 10-year period (1995–2004). The incidence of leak by surgical site, timing of diagnosis, method of detection, and treatment was noted. Complications were entered prospectively by a nurse practitioner directly involved in patient care. Standardized criteria for diagnosis were used. A logistic regression model was used to discriminate statistical variation. Results:A total of 1223 patients underwent resection and anastomosis during the study period. Mean age was 59.1 years. Leaks occurred in 33 patients (2.7%). Diagnosis was made a mean of 12.7 days postoperatively, including four beyond 30 days (12.1%). There was no difference in leak rate by surgeon (3.6% vs. 2.2%; P = 0.08). The leak rate was similar by surgical site except for a markedly increased leak rate with ileorectal anastomosis (P = 0.001). Twelve leaks were diagnosed clinically versus 21 radiographically. Contrast enema correctly identified only 4 of 10 leaks, whereas CT correctly identified 17 of 19. A total of 14 of 33 (42%) patients had their leak diagnosed only after readmission. Fifteen patients required fecal diversion, whereas 18 could be managed nonoperatively. Conclusions:Anastomotic leaks are frequently diagnosed late in the postoperative period and often after initial hospital discharge, highlighting the importance of prospective data entry and adequate follow-up. CT scan is the preferred diagnostic modality when imaging is required. More than half of leaks can be managed without fecal diversion.

Transanal endoscopic microsurgery: a prospective evaluation of functional results.

PURPOSELocal excision is a commonly used technique for many benign and selected malignant rectal lesions. Compared with radical resection, it is associated with decreased morbidity and mortality and improved functional results. Transanal endoscopic microsurgery is gaining popularity because of its ability to access the upper rectum and its precise excision techniques. However, the functional consequences have not been extensively studied.METHODSAll patients subject to transanal endoscopic microsurgery prospectively completed preoperative and postoperative (6 weeks) surveys including Fecal Incontinence Severity Index, Fecal Incontinence Quality of Life, number of bowel movements per 24 hours, and ability to defer defecation. All data were collected by an independent research coordinator. Demographics, operative details, and complications were also collected prospectively.RESULTSForty-one patients successfully underwent transanal endoscopic microsurgery. Fourteen patients had malignant lesions and 27 had benign lesions. Two patients required abdominoperineal resection based on postoperative diagnosis. Thirty-nine patients have completed follow-up and were available for review. Mean length of surgery was 64 minutes and length of stay was 0.9 day. Average distance from the anal verge to the proximal tumor margin was 11.4 cm and mean tumor size was 8.75 cm. Twenty-three patients had full-thickness excision with primary closure, ten had full-thickness excision without closure, five had partial-thickness excision, one had an excision of a mass in the anovaginal septum, and one had resection of an anastomotic stricture. Each patient served as his own control. Preoperative and postoperative number of bowel movements per 24 hours were 2.0 and 2.0, respectively. Preoperative vs. postoperative urgency (ability to defer defecation less than ten minutes) was unchanged. Mean preoperative and postoperative Fecal Incontinence Severity Index scores were 2.4 (range, 0–43) and 2.4 (range, 0–17), respectively (higher scores indicate worse function). In addition, the four parameters measured by the Fecal Incontinence Quality of Life survey were unchanged when preoperative and postoperative data were compared.CONCLUSIONSTransanal endoscopic microsurgery allows precise excision of tumors throughout the rectum. However, it involves inserting a 40-mm-diameter operating proctoscope and significant operating times. Despite this, as measured by ability to defer defecation, number of bowel movements per 24 hours, Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life survey, transanal endoscopic microsurgery has no detrimental affect on fecal continence.

Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial

Summary Background Local excision is an organ-preserving treatment alternative for patients with stage I rectal cancer. However, local excision alone is associated with a high risk of local recurrence and inferior survival compared to transabdominal rectal resection. Here we investigate the oncologic and functional outcomes of neoadjuvant chemoradiotherapy and local excision for T2N0 rectal cancer. Methods This was a prospective, multi-institutional, single arm phase 2 trial for patients with clinically-staged T2N0 distal rectal cancer, treated with neoadjuvant chemoradiotherapy consisting of capecitabine (original dose 825mg/m2, twice daily, on days 1-14 and 22-35) , oxaliplatin (50mg/m2 weeks 1, 2, 4, 5), and radiation (5 days/week at 1.8 Gy/day for 5 weeks to a dose of 45 Gy, then a boost, for a total dose of 54 Gy) followed by local excision. Due to adverse events during chemoradiotherapy, the dose of capecitabine was reduced to 725 mg /m2, twice daily, 5 days/week, for 5 weeks, and the total dose of radiation to 50.4 Gy. Patients were followed at scheduled intervals and evaluated for recurrence and survival. Anorectal function (ARF) and quality of life (QOL) were assessed at baseline and one year after surgery, using validated instruments. The primary endpoint was 3-year disease-free survival for all eligible patients and for patients who completed chemotherapy and radiation, and had ypT0, ypT1, or ypT2 tumors, and negative resection margins. This trial is registered with ClinicalTrials.gov, number NCT00114231. Findings Seventy-nine eligible patients were accrued to the trial, and started nCRT. Three patients did not complete nCRT or LE per-protocol. Four additional patients completed protocol treatment, but one had a positive margin and three had ypT3 tumours. Median follow-up was 56 months. Of the 79 patients, five (6%) developed distant recurrence, and three (4%) recurred locally. All but two underwent salvage surgery. Three-year disease-free survival and overall survival for the entire group were 88% (0.88 (95% CI: 0.81, 0.96) and 95% (95% CI: 0.90, 1.00), respectively. Overall 14 (29%) of 79 patients had grade 3-4 gastrointestinal adverse events, 12 (16%) of 79 patients had grade 3-4 pain as an adverse event, 12 (16%) of 79 patients had grade 3-4 hematological adverse events, and 9 (11%) of 79 patients had grade 3 dermatologic adverse events during chemoradiation. Six (8%) of the 77 patients who had surgery had grade 3 pain, 3(4%) of 77 patients had grade 3-4 hemorrhage, 3 (4%) of 77 patients had gastrointestinal adverse events, 2 (3%) of 77 patients had infectious/febrile neutropenia, 2 (3%) of 77 patients had hematological adverse events, and one (1%) had neurological adverse events. The rectum was preserved in 72 of the 79 (91%) patients. ARF and QOL were unchanged one year after surgery compared to baseline. Interpretation Most patients with T2N0 rectal cancer treated with nCRT and LE achieved organ preservation without deterioration of their quality of life. The estimated 3-year DFS rate was within the defined margin of efficacy. Our data suggest that nCRT followed by LE may be considered as an organ-preserving alternative in carefully selected patients with clinically-staged T2N0 tumours who refuse, or are not candidates for, transabdominal resection.

Identification of a biomarker profile associated with resistance to neoadjuvant chemoradiation therapy in rectal cancer

Objective:To identify a biomarker profile associated with tumor response to chemoradiation (CRT) in locally advanced rectal cancer. Background:Rectal cancer response to neoadjuvant CRT is variable. Whereas some patients have a minimal response, others achieve a pathologic complete response (pCR) and have no viable cancer cells in their surgical specimens. Identifying biomarkers of response will help select patients more likely to benefit from CRT. Methods:This study includes 132 patients with locally advanced rectal cancer treated with neoadjuvant CRT followed by surgery. Tumor DNA from pretreatment tumor biopsies and control DNA from paired normal surgical specimens was screened for mutations and polymorphisms in 23 genes. Genetic biomarkers were correlated with tumor response to CRT (pCR vs non-pCR), and the association of single or combined biomarkers with tumor response was determined. Results:Thirty-three of 132 (25%) patients achieved a pCR and 99 (75%) patients had non-pCR. Three individual markers were associated with non-pCR; v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog mutation (P = 0.0145), cyclin D1 G870A (AA) polymorphism (P = 0.0138), and methylenetetrahydrofolate reductase (NAD(P)H) C677T (TT) polymorphism (P = 0.0120). Analysis of biomarker combinations revealed that none of the 27 patients with both tumor protein p53 (p53) and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog mutations had a pCR. Further, in patients with both p53 and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog mutations or the cyclin D1 G870A (AA) polymorphism or the methylenetetrahydrofolate reductase (NAD(P)H) C677T (TT) polymorphism (n = 52) the association with non-pCR was further strengthened; 51 of 52 (98%) of patients were non-pCR. These biomarker combinations had a validity of more than 70% and a positive predictive value of 97% to 100%, predicting that patients harboring these mutation/polymorphism profiles will not achieve a pCR. Conclusions:A specific biomarker profile is strongly associated with non-pCR to CRT and could be used to select optimal oncologic therapy in rectal cancer patients. ClinicalTrials.org Identifier: NCT00335816.

Urgent Subtotal Colectomy for Severe Inflammatory Bowel Disease

PURPOSEThe purpose of this study was to assess the safety of subtotal colectomy and outcomes after this procedure in the modern era of immunosuppressive agents and primary pelvic pouch surgery.METHODSAll patients undergoing subtotal colectomy with ileostomy for ulcerative colitis or Crohn’s colitis from July 1, 1990 to June 30, 2003 were identified from a prospective database. Only patients who were operated on while hospitalized for disease exacerbation were included in the analysis. Age at colectomy, preoperative days in the hospital, postoperative length of stay, and complications were recorded. The medical records were then reviewed for duration of disease, preoperative diagnosis, use of steroids and immunomodulators, parenteral nutrition, endoscopy findings, albumin level, postoperative diagnosis, and ultimate disposition.RESULTSOne hundred one patients underwent subtotal colectomy for inflammatory bowel disease during the study period. Seventy-four patients met all the inclusion criteria. The mean age was 35.9 (range, 18–86) years. Median duration of disease was 36 (0–240) months, but 28 patients had colitis for less than 1 year, whereas 10 patients had disease of greater than 10 years duration at the time of colectomy. Median preoperative hospital stay was 7 (range, 0–43) days and median postoperative length of stay was 6.5 (range, 4–37) days. Sixty-six patients underwent surgery for refractory exacerbation, 5 for free perforation, 2 for abscess, and 1 patient for hemorrhage. Twenty-seven patients (36.5 percent) had a change in diagnosis after surgery. Complications occurred in 17 patients (23 percent), including 8 cases of central venous catheter–associated thrombosis; 7 of these occurred in patients who had been hospitalized for more than a week before surgery. In the ulcerative colitis patients, 31 of 52 ultimately underwent ileal pouch–anal anastomosis, but 20 (39 percent) chose either completion proctectomy or no further surgery.CONCLUSIONSSubtotal colectomy with ileostomy remains a safe and effective treatment for patients requiring urgent surgery for severe inflammatory bowel disease. Because of the substantial incidence of change in diagnosis and satisfaction in many patients with an ileostomy, subtotal colectomy with ileostomy may be preferable to primary ileal pouch–anal anastomosis, even when a pouch is considered safe.

Nitroglycerin ointment for anal fissures

PURPOSE: Topical nitrates have been shown to cause nitric oxide-mediated relaxation of the internal anal sphincter. Previous reports have suggested initial efficacy in the treatment of anal fissures. The aim of this study was to assess the longer-term usefulness of this treatment. METHODS: Thirty-three patients with an anal fissure were treated with topical 0.3% nitroglycerin ointment, applied to the anoderm three times per day and after bowel movements. Patients were followed up by office visits and telephone calls until symptoms were completely resolved or treatment was noted to be ineffective or intolerable. RESULTS: Thirty-three patients were treated, 16 with acute fissures, and 17 with chronic fissures. Nitroglycerin was effective in 9 of 16 acute fissures (56%), and 7 of 17 chronic fissures (41%). Even when effective, 75% of patients reported an adverse reaction. CONCLUSIONS: Topical nitroglycerin was only effective in approximately one-half of patients with an anal fissure. There was a very high incidence of adverse reactions. In our experience nitroglycerin more often causes a headache than treats the symptoms of anal fissure.

Use of frozen section analysis in the treatment of basal cell carcinoma

Frozen section margin verification has been used in the treatment of basal cell carcinoma at our institution for the past 13 years. A review of the last 450 cases has shown frozen section to be most helpful in treating recurrent tumors where microscopic tumor foci extend beyond clinical margins in 45% of cases. Frozen section analysis may be of value in selected patients with primary tumors, but its routine use is not indicated for the majority of these lesions, since complete excision is possible without relying on frozen section in 90% of cases.

Anastomotic Leaks after Bowel Resection: What Does Peer Review Teach Us about the Relationship to Postoperative Mortality?

BACKGROUND Anastomotic leak is a dreaded complication of intestinal surgery and has been associated with a high mortality rate. But it is uncertain exactly which patient populations are at risk of death from the leak. We sought to assess the impact of surgeon volume on leak rate and to better understand the relationship of a leak to postoperative mortality. STUDY DESIGN All adult patients having a small or large bowel resection with anastomosis at a university hospital from July 2003 to June 2006 were entered into a prospectively maintained quality database; data were entered by a specially trained nurse practitioner who rounded daily with housestaff. Patients with a postoperative leak based on standardized criteria were identified. Patient characteristics, surgical procedure, and operating surgeon were noted. Overall complication and leak rates by surgeon were compared using Fishers exact test. Individual case review by a group of peers was performed for all patients with a leak who died, to determine the relationship to mortality. RESULTS Five hundred fifty-six patients underwent resection with anastomosis during the study period. There were 27 patients with leaks (4.9%), 6 of whom died. Leak rate for the highest-volume surgeons ranged from 1.6% to 9.9% (p <0.01), and overall complication rate varied from 30.5% to 44% (p=0.04). In four of six deaths, leaks occurred in very ill patients undergoing emergency procedures and appeared to be premorbid events. In only one patient did the leak appear to be the primary cause of death. CONCLUSIONS The variability in leak rate by surgeons doing similar operations suggests that many leaks may be preventable. But death after a leak is most often a surrogate for a critically ill patient and was infrequently the actual cause of death.

A novel approach to assessing technical competence of colorectal surgery residents: The development and evaluation of the colorectal objective structured assessment of technical skill (COSATS)

Objective: To develop and evaluate an objective method of technical skills assessment for graduating subspecialists in colorectal (CR) surgery—the Colorectal Objective Structured Assessment of Technical Skill (COSATS). Background: It may be reasonable for the public to assume that surgeons certified as competent have had their technical skills assessed. However, technical skill, despite being the hallmark of a surgeon, is not directly assessed at the time of certification by surgical boards. Methods: A procedure-based, multistation technical skills examination was developed to reflect a sample of the range of skills necessary for CR surgical practice. These consisted of bench, virtual reality, and cadaveric models. Reliability and construct validity were evaluated by comparing 10 graduating CR residents with 10 graduating general surgery (GS) residents from across North America. Expert CR surgeons, blinded to level of training, evaluated performance using a task-specific checklist and a global rating scale. The mean global rating score was used as the overall examination score and a passing score was set at “borderline competent for CR practice.” Results: The global rating scale demonstrated acceptable interstation reliability (0.69) for a homogeneous group of examinees. Both the overall checklist and global rating scores effectively discriminated between CR and GS residents (P < 0.01), with 27% of the variance attributed to level of training. Nine CR residents but only 3 GS residents were deemed competent. Conclusions: The Colorectal Objective Structured Assessment of Technical Skill effectively discriminated between CR and GS residents. With further validation, the Colorectal Objective Structured Assessment of Technical Skill could be incorporated into the colorectal board examination where it would be the first attempt of a surgical specialty to formally assess technical skill at the time of certification.

Does alpha sympathetic blockade prevent urinary retention following anorectal surgery

Urinary retention is the most common complication after anorectal surgery, with rates as high as 52 percent reported. With the trend toward early discharge, avoidance of this complication is particularly important. Perioperative fluid restriction and the use of short-acting anesthetics have been shown to be effective in decreasing postoperative urinary retention rates but are not applicable in all cases. Reflex sympathetic stimulation, possibly as a result of perianal pain, may lead to increased muscular tone of the internal sphincter at the bladder neck. This theory had led to the effective use of alpha-adrenergic blockade in the treatment of established cases of urinary retention after anorectal surgery, herniorrhaphy, and major pelvic surgery. However, the prophylactic role of alpha blockade after anorectal surgery has not been studied. In a double-blind, prospective, randomized study, 51 patients were treated with either prazosin and alpha-adrenergic blocker or placebo prior to and immediately after elective anorectal surgery. Urinary retention rates were similar in the two groups. At this time, prophylactic alpha-adrenergic blockade is not recommended for the prevention of urinary retention after anorectal surgery.