Hospital and geographic variability in two colorectal cancer surgery outcomes: complications and mortality after complications.

BACKGROUND: The purpose of this study was to describe hospital and geographic variation in 30-day risk of surgical complications and death among colorectal cancer (CRC) patients and the extent to which patient-, hospital-, and census-tract-level characteristics increased risk of these outcomes. METHODS: We included patients at least 66 years old with first primary stage I-III CRC from the 2000-2005 National Cancer Institute's Surveillance, Epidemiology, and End Results data linked with 1999-2005 Medicare claims. A multilevel, cross-classified logistic model was used to account for nesting of patients within hospitals and within residential census tracts. Outcomes were risk of complications and death after a complication within 30 days of surgery. RESULTS: Data were analyzed for 35,946 patients undergoing surgery at 1,222 hospitals and residing in 12,187 census tracts; 27.2 % of patients developed complications, and of these 13.4 % died. Risk-adjusted variability in complications across hospitals and census tracts was similar. Variability in mortality was larger than variability in complications, across hospitals and across census tracts. Specific characteristics increased risk of complications (e.g., census-tract-poverty rate, emergency surgery, and being African-American). No hospital characteristics increased complication risk. Specific characteristics increased risk of death (e.g. census-tract-poverty rate, being diagnosed with colon (versus rectal) cancer, and emergency surgery), while hospitals with at least 500 beds showed reduced death risk. CONCLUSIONS: Large, unexplained variations exist in mortality after surgical complications in CRC across hospitals and geographic areas. The potential exists for quality improvement efforts targeted at the hospital and/or census-tract levels to prevent complications and augment hospitals' ability to reduce mortality risk.

Treatment of fistula-in-ano using a porcine small intestinal submucosa anal fistula plug.

BACKGROUND: Porcine small intestinal submucosa (SIS) is a bioprosthetic collagen material used in the management of various surgical conditions, especially hernia repairs. We studied the effectiveness of porcine SIS Bioprosthetic plug (Surgisis AFP, Cook Biotech Inc., West Lafayette, IN, USA) in the treatment of fistula-in-ano. METHODS: A prospective multi-institutional study was conducted on 73 patients with anorectal fistulas of differing etiologies. All plugs were inserted in the operating room under anesthesia in patients with preoperative bowel preparation. Regular follow-up was scheduled at 2 weeks, 3, 6, and 12 months. The primary end point was complete closure of the fistula and cessation of drainage over the follow-up period. Seventy-eight AFPs were inserted in 73 patients (28 women and 45 men). Rectovaginal fistulas were excluded. Crohn's disease accounted for 11% (8/73) of the patients. Seventy-three percent of patients (n = 53) had primary fistulas whereas 27% (N = 20) had recurrent fistulas. RESULTS: The plug extrusion (fallout) rate was 9% (7/78). There was no difference in closure rates between primary and recurrent fistulas (primary = 20/53 = 38% and recurrent 8/20 = 40%). The overall patient success rate was 38% (28/73) and the plug success rate was 39.5% when plug fallouts were eliminated. The fistulas in four out of eight patients with Crohn's disease closed (50%). There were no intraoperative complications. There were four postoperative abscesses (4/73; 5%). CONCLUSIONS: Use of AFP for treatment of fistula-in-ano is safe and modestly effective in reasonable long-term (15 months) follow-up. This sphincter conserving procedure should be included in the armamentarium of surgeons in the management of transsphincteric or suprasphincteric fistulas.

Early multi-institution experience with single-incision laparoscopic colectomy.

PURPOSE: Single-incision laparoscopic colectomy represents a potential advance in minimally invasive surgical approaches to colorectal disease. Although widely promoted, outcome data are virtually absent. A group of highly experienced laparoscopic attending colorectal surgeons convened to standardize technique and prospectively record operative details and outcomes. METHODS: Single-incision laparoscopic colectomy was performed by 10 experienced attending colorectal surgeons with minimal or no prior single-incision laparoscopic colectomy experience. Surgeon rating of ergonomics and 15 components of operation conduct was compared with conventional multiple-port laparoscopic colectomy. Patient demographics, operative details, and outcome data were prospectively collected. RESULTS: Thirty-nine single-incision laparoscopic colectomies were performed (25 right colectomies, 5 ileocolic resections, 8 sigmoidectomies, and 1 low anterior resection). Underlying pathology included polyps (12), cancer (15), Crohn's disease (5), and diverticulitis (7). Patients were highly selected with a mean body mass index of 25.6 (range, 16-40). Two conversions to open resection occurred, 1 because of fistula and 1 because of adhesions, in patients with a mean body mass index of 34. An additional port was required in 3 patients. Mean incision length was 4.2 cm (range, 2.5-8) and operative time was 120 minutes (range, 68-210). Complications included 1 wound infection and 2 anastomotic bleeds requiring transfusion. Average length of stay was 4.4 days (range, 2-8). Mean lymph node harvest was 19 (range, 12-39). Exposure, instrument conflict, ergonomics, ease of instrumentation, and camera operation were rated significantly more difficult with single-incision laparoscopic colectomy than with multiple-port laparoscopic colectomy. CONCLUSIONS: Preliminary data demonstrate that single-incision laparoscopic colectomy can be performed safely in selected patients by experienced surgeons. The benefits of single-incision compared with multiple-port laparoscopic colectomy are not immediately evident. Despite the advanced skills of the faculty, a learning curve of undetermined length still exists in which specific components of single-incision laparoscopic colectomy are more difficult than multiple-port laparoscopic colectomy, and areas of focus remain that require advances to make single-incision laparoscopic colectomy equivalent to multiple-port laparoscopic colectomy. The multi-institutional registry will enable further analysis of single-incision laparoscopic colectomy.

Ex vivo sentinel lymph node mapping in laparoscopic resection of colon cancer.

AIM: The study examined the feasibility and potential benefit of ex vivo sentinel lymph node (SLN) mapping, including multilevel sectioning (MLS) and immunohistochemistry (IHC) in colon cancer patients undergoing laparoscopic colectomy. The secondary goals were (i) to identify patient and tumour characteristics that might influence the success of the SLN technique, (ii) to investigate the extent of lymphadenectomy required to encompass tumour-positive nonsentinel lymph nodes (NSLN) and (iii) to ascertain the association of SLN status with oncological outcomes. METHOD: SLN mapping was performed after specimen extraction using 1% Isosulfan blue. The SLNs were analysed with H&E staining after MLS, and if negative, IHC was performed. NSLNs were grouped by distance either greater than or less than 4 cm from the tumour. RESULTS: Seventy-one patients completed the study between 2003 and 2007. Using H&E with MLS, the accuracy of SLN mapping was 76%, sensitivity was 52% and the false-negative rate was 48%. Excluding patients with clinically positive lymph nodes resulted in a significant improvement in accuracy to 81% and decreased the false-negative rate to 30%. Furthermore, as the only positive NSLN > 4 cm from the tumour was grossly positive, SLN mapping with a 4-cm mesenteric cuff would have given 100% sensitivity in patients without macroscopically involved nodes. CONCLUSIONS: SLN mapping may be of value in selected patients. It may be possible to accurately stage patients with a 4-cm cuff of mesentery, although further validation of this proposal is required.

Predictors of disease-free survival in rectal cancer patients undergoing curative proctectomy.

OBJECTIVE: To identify the factors that affect the disease-free survival (DFS) of rectal cancer patients. METHOD: Patients from an IRB approved rectal cancer database were reviewed (1990-2000). All patients underwent either abdominoperineal resection or low anterior resection using total mesorectal excision with curative intent. Univariate and multivariate analyses were performed to analyse the factors that influenced DFS. RESULTS: A total of 304 patients were reviewed (mean age 64, 52% male). Seventy-seven per cent of patients received neoadjuvant therapy (28.6% short-course radiation therapy (RT), 35.5% long-course RT, 12.5% chemo-RT). The radial margin was involved with tumour in 5.2% of patients (final pathology). The overall survival rate was 85.2% with a mean follow-up time of 33 +/- 26 months. The mean time to death was 34.8 +/- 26.8 months. Local recurrence (+/- distant recurrence) occurred in 4%. Anastomotic leaks occurred in 3.6% of patients. Overall pathologic stage, pathologic T stage, nodal status, the use of adjuvant chemotherapy, tumour fixation, involvement of the radial margin, the presence of mucin, and lymphatic and perineural invasion (PNI) were predictors of DFS by univariate analysis. Of note, anastomotic leaks and obstructing cancers did not influence DFS. Using multivariate analysis with backward elimination, overall pathologic stage, radial margin status, adjuvant chemotherapy, and PNI predicted the DFS. CONCLUSION: Major predictors of DFS in rectal cancer are the overall pathologic stage, adjuvant chemotherapy, radial margin status and PNI. Radial margin status may be a marker of tumour aggressiveness and should be considered in deciding on adjuvant chemotherapy.

The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery.

OBJECTIVES: To describe the reliability and validity of the Postoperative Morbidity Survey (POMS). To describe the level and pattern of short-term postoperative morbidity after major elective surgery using the POMS. STUDY DESIGN AND SETTING: This was a prospective cohort study of 439 adults undergoing major elective surgery in a UK teaching hospital. The POMS, an 18-item survey that address nine domains of postoperative morbidity, was recorded on postoperative days 3, 5, 8, and 15. RESULTS: Inter-rater reliability was perfect for 11/18 items (Kappa=1.0), with Kappa=0.94 for 6/18 items. A priori hypotheses that the POMS would discriminate between patients with known measures of morbidity risk, and predict length of stay were generally supported through observation of data trends, and there was statistically significant evidence of construct validity for all but the wound and neurological domains. POMS-defined morbidity was present in 325 of 433 patients (75.1%) remaining in hospital on postoperative day 3 after surgery, 231 of 407 patients (56.8%) on day 5, 138 of 299 patients (46.2%) on day 8, and 70 of 111 patients (63.1%) on day 15. Gastrointestinal (47.4%), infectious (46.5%), pain-related (40.3%), pulmonary (39.4%), and renal problems (33.3%) were the most common forms of morbidity. CONCLUSION: The POMS is a reliable and valid survey of short-term postoperative morbidity in major elective surgery. Many patients remain in hospital without any morbidity as recorded by the POMS.

Plasma volume changes associated with two hydroxyethyl starch colloids following acute hypovolaemia in volunteers.

This randomised double blind prospective study compared the effective intravascular volume expansion and maintenance, with two types of starches following induced haemorrhagic hypovolaemia. Twenty healthy male volunteers aged between 18 and 65 year were bled 10% of their total blood volume in fully monitored conditions and under the supervision of a trained specialist doctor and research nurse. The lost blood volume was replaced using one of the starch solutions. Effective intravascular volume expansion was monitored hourly using the (51)Cr radio-labelled red blood cell dilution technique, we compared the effects of two hydroxyethyl starch colloid preparations, one a high molecular weight and the other a low molecular weight preparation, on the plasma volume changes over time. The large molecular weight starch (Hextend) provided a less well-sustained volume expansion effect than the smaller one (Voluven)

The effects of balanced versus saline-based hetastarch and crystalloid solutions on acid-base and electrolyte status and gastric mucosal perfusion in elderly surgical patients.

UNLABELLED: The IV administration of sodium chloride solutions may produce a metabolic acidosis and gastrointestinal dysfunction. We designed this trial to determine whether, in elderly surgical patients, crystalloid and colloid solutions with a more physiologically balanced electrolyte formulation, such as Hartmann's solution and Hextend, can provide a superior metabolic environment and improved indices of organ perfusion when compared with saline-based fluids. Forty-seven elderly patients undergoing major surgery were randomly allocated to one of two study groups. Patients in the Balanced Fluid group received an intraoperative fluid regimen that consisted of Hartmann's solution and 6% hetastarch in balanced electrolyte and glucose injection (Hextend). Patients in the Saline group were given 0.9% sodium chloride solution and 6% hetastarch in 0.9% sodium chloride solution (Hespan). Biochemical indices and acid-base balance were determined. Gastric tonometry was used as a reflection of splanchnic perfusion. Postoperative chloride levels demonstrated a larger increase in the Saline group than the Balanced Fluid group (9.8 vs 3.3 mmol/L, P = 0.0001). Postoperative standard base excess showed a larger decline in the Saline group than the Balanced Fluid group (-5.5 vs -0.9 mmol/L, P = 0.0001). Two-thirds of patients in the Saline group, but none in the Balanced Fluid group, developed postoperative hyperchloremic metabolic acidosis (P = 0.0001). Gastric tonometry indicated a larger increase in the CO2 gap during surgery in the Saline group compared with the Balanced Fluid group (1.7 vs 0.9 kPa, P = 0.0394). In this study, the use of balanced crystalloid and colloid solutions in elderly surgical patients prevented the development of hyperchloremic metabolic acidosis and resulted in improved gastric mucosal perfusion when compared with saline-based solutions. IMPLICATIONS: This prospective, randomized, blinded trial showed that, in elderly surgical patients, the use of balanced IV solutions can prevent the development of hyperchloremic metabolic acidosis and provide better gastric mucosal perfusion compared with saline-based fluids.

Germline mutations in the multiple endocrine neoplasia type 1 gene: evidence for frequent splicing defects.

Multiple endocrine neoplasia type 1 (MEN 1) is a familial cancer syndrome characterized by parathyroid hyperplasia, pituitary adenomas, and neuroendocrine tumors of the pancreas and duodenum. In 1997, the MEN1 tumor suppressor gene was identified, and numerous germline mutations have been reported to be distributed throughout the gene. We used single strand conformational variant (SSCV) analysis to search for germline mutations in the members of 33 kindreds with a confirmed diagnosis of MEN 1. SSCV analysis revealed 25 conformational variants representing germline mutations that are predicted to result in loss of normal menin function. Twenty different disease-associated mutations were identified: five resulting in potential abnormal RNA splicing, two missense mutations, seven nonsense mutations, and six frameshift mutations. The aberrant splice products were identified and confirmed by RT-PCR and direct sequence analysis for two of the five splice mutations. Sixteen of the 20 (80%) mutations identified have not been previously reported. Mutations were not identified in eight kindreds with signs and symptoms consistent with MEN 1. The SSCV analysis revealed mutations in 76% (25 of 33) of the kindreds investigated, thus showing SSCV analysis to be a reliable mutation detection strategy. One-fifth of the mutations identified in this study involve intron sequences, therefore, highlighting the importance of including intron sequences in the search for germline mutations in the MEN1 gene. The need to investigate the entire gene when characterizing new MEN 1 families presents challenges in the translation of genetic studies to efficient clinical diagnostic tests.

Pancreatic polypeptide is a useful plasma marker for radiographically evident pancreatic islet cell tumors in patients with multiple endocrine neoplasia type 1.

BACKGROUND: The usefulness of human pancreatic polypeptide (hPP) as a plasma marker for islet cell neoplasms is controversial. We sought to determine the relation between fasting plasma hPP levels and radiographically detectable pancreatic islet cell tumors in patients with multiple endocrine neoplasia type 1 (MEN 1). METHODS: Fasting plasma hPP levels were measured prospectively in 202 individuals from 31 independent kindreds with MEN 1. Plasma levels greater than 3.0 times the normal age-specific values were defined as elevated. Patients with elevated plasma hPP levels were evaluated with computed tomographic scanning and magnetic resonance imaging, octreotide scanning, or selective angiography. RESULTS: Twenty-two patients had elevated fasting plasma hPP levels, and 20 of these patients were evaluated radiographically. Pancreatic lesions were detected in 19 patients. A group of eight patients with normal basal fasting plasma hPP levels were evaluated with computed tomography, magnetic resonance imaging, octreotide scanning, or selective angiography based on clinical presentation. One patient in this group had an imaging study that was positive for a pancreatic lesion. CONCLUSIONS: The presence of a markedly elevated fasting plasma hPP level in patients with MEN 1 is 95% sensitive and 88% specific for the presence of radiographically detectable pancreatic islet cell tumors.

Diagnostic laparoscopy -- a new diagnostic and therapeutic modality.

PIP: Laparoscopy, is technique, indications, contraindications, and complications as well as the author's personal experience with it are described. It is a new procedure for diagnosis and treatment of intraabdominal and pelvic conditions. It is a safe and effective method of tubal ligation with shorter hospitalization time. The complete procedure for laparoscopy is discussed in the article. Most patients are able to leave the hospital the day of surgery, and the clips are removed in the office in 72 hours. Laparoscopy is used in sterilization and diagnostically in cases of infertility, pelvic pain, congenital anomalies, second look procedures, and removal of IUD. It should not be used in patients in whom anesthesia is contraindicated, or those with intestinal obstruction, peritonitis, and extensive abdominal scarring. The recovery rate is virtually 100% within 24 to 48 hours following laproscopy. Complications in the author's experience with laparoscopy include, perforation of inferior epigastric artery, postoperative PID, pneumo-omentum failure, pelvic vessel hematoma, and adenocarcinoma of the endometrium.^ieng