Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial.

OBJECTIVE: To assess with a single-blinded, multicenter, randomized trial, the postoperative results in patients undergoing sphincter-saving rectal resection for cancer without preoperative mechanical bowel preparation (MBP). BACKGROUND: The collective evidence from literature strongly suggests that MBP, before elective colonic surgery, is of no benefit in terms of postoperative morbidity. Very few data and no randomized study are available for rectal surgery and preliminary results conclude toward the safety of rectal resection without MBP. METHODS: From October 2007 to January 2009, patients scheduled for elective rectal cancer sphincter-saving resection were randomized to receive preoperative MBP (ie, retrograde enema and oral laxatives) or not. Primary endpoint was the overall 30-day morbidity rate. Secondary endpoints included mortality rate, anastomotic leakage rate, major morbidity rate (Dindo III or more), degree of discomfort for the patient, and hospital stay. RESULTS: A total of 178 patients (103 men), including 89 in both groups (no-MBP and MBP groups), were included in the study. The overall and infectious morbidity rates were significantly higher in no-MBP versus MBP group, 44% versus 27%, P = 0.018, and 34% versus 16%, P = 0.005, respectively. Regarding both anastomotic leakage and major morbidity rates, there was no significant difference between no-MBP and MBP group: 19% versus 10% (P = 0.09) and 18% versus 11% (P = 0.69), respectively. Moderate or severe discomfort was reported by 40% of prepared patients. Mortality rate (1.1% vs 3.4%) and mean hospital stay (16 vs 14 days) did not differ significantly between both groups. CONCLUSIONS: This first randomized trial demonstrated that rectal cancer surgery without MBP was associated with higher risk of overall and infectious morbidity rates without any significant increase of anastomotic leakage rate. Thus, it suggests continuing to perform MBP before elective rectal resection for cancer.

Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery.

BACKGROUND: Earlier meta-analyses of small randomized trials suggested that mechanical bowel preparation (MBP) should be omitted before colorectal surgery because it does not affect complication rates 0 mortality and may be even harmful; however, more recent large randomized trials suggested an increased occurrence of pelvic abscesses in the absence of MBP. Therefore, an updated large meta-analysis was conducted to re-evaluate the role of MBP in colorectal surgery. Furthermore, the influence of different kind of MBP regimes on infectious outcomes was examined. METHODS: The meta-analysis was conducted according to the QUOROM statement; the inclusion criteria were randomized clinical trials comparing MBP with no MBP before colorectal surgery. The primary outcome was anastomotic leakage; secondary outcomes were other septic complications. RESULTS: Fourteen trials were included with a total number of 4859 patients: 2452 in the MBP group and 2407 in the no MBP group. We found no statistical difference between the groups for anastomotic leakage [OR = 1.12 (0.82-1.53), P = 0.46], pelvic or abdominal abscess (P = 0.75), and wound sepsis (P = 0.11). When all surgical site infections were considered, the meta-analysis favored no MBP [OR = 1.40 (1.05-1.87), P = 0.02].Sensitivity analyses showed similar results for all subgroups but when poor or small trials were excluded, there was a slightly higher risk of deep abdominal abscesses with no MBP, however, the number needed to harm was as high as 333 patients, suggesting this difference to be not clinically relevant. The use of different MBP regimes did not influence primary and secondary outcomes. The main limitation concerned rectal surgery for which the limited data preclude any interpretation. CONCLUSION: Although it did not confirm the harmful effect of mechanical bowel preparation (suggested by previous meta-analyses), this meta-analysis including almost 5000 patients, demonstrates with a high level of evidence that any kind of mechanical bowel preparation should be omitted before colonic surgery.

Focal nodular hyperplasia of the liver in patients previously treated for pediatric neoplastic diseases.

SUMMARY: The discovery of a liver nodule during postcancer follow-up suggests malignancy recurrence. However, patients previously treated for pediatric cancers are at greater risk of developing benign hepatic tumors, raising the problems of getting an accurate noninvasive diagnosis. Here we report 3 cases of focal nodular hyperplasia of the liver in patients previously treated for pediatric neoplastic diseases. Radiologic findings and needle-biopsies remained insufficient in 2 cases to rule out metastasis or a potentially threatening tumor. Only surgical resection led to positive diagnosis and prevented complications. However, a review of the literature shows that if the nodule presents with typical features of focal nodular hyperplasia a close imaging follow-up is all that is recommended.

Safety and long-term outcome of a new concept for surgical adhesion-reduction strategies (Prevadh): a prospective, multicenter study.

BACKGROUND/AIMS: No agent has been consistently effective in preventing formation of peritoneal adhesions and postoperative bowel obstruction after abdominal surgery. The aim of this prospective multicenter study was to assess clinical safety and efficiency of a new adhesion-reduction barrier METHODOLOGY: Between September 2000 and April 2001, Prevadh was used in 78 patients. Operative procedures included 25 hepatic resections, 7 cholecystectomies, 32 colonic resections, 7 protectomies, 3 colostomy or recovery of continuity, 1 gynaecologic surgery and 3 others. Eleven patients were operated on by laparoscopy and 67 by laparotomy. RESULTS: The overall incidence of abscesses and wound complications was 2.4% and 9% respectively. After a mean follow-up of 36 months (range: 4-51 months), no patients experienced adverse events related to the adhesion barrier. Surgical reoperative procedures were performed in 10 patients for unrelated causes and no bowel obstruction occurred within the protected area. CONCLUSIONS: This study confirmed the safety of Prevadh adhesion barrier and suggested that this resorbable barrier might provide prevention from adhesion formation on peritoneal injured surfaces. However, a large randomized controlled trial remains necessary to prove the real effectiveness of adhesion barriers on clinical long-term outcome.

Risk factors for mortality and intra-abdominal complications after pancreatoduodenectomy: multivariate analysis in 300 patients.

BACKGROUND: Studies of risk factors after pancreatoduodenectomy are few: some concern restricted populations and others are based on administrative data. METHODS: Multicenter clinical data were collected for 300 patients undergoing pancreatoduodenectomy to determine (by univariate and multivariate analysis) preoperative and intraoperative risk factors for mortality and intra-abdominal complications (IACs), including pancreatic fistula. Fourteen factors including the center and volume effect were analyzed. RESULTS: In univariate analysis, mortality was increased with age 70 years or more, extended resection(s), and volume and center effects. IACs occurred more often with main pancreatic duct diameter of 3 mm or less, normal parenchyma texture, extended resection(s), and the center effect. Pancreatic fistula was more frequent with main pancreatic duct diameter of 3 mm or less, normal parenchyma texture, and the center effect. In multivariate analysis, independent risk factor(s) for mortality were age greater than 70 years (odds ratio [OR], 3; 95% confidence interval [CI], 1.3-8) and extended resection (OR, 5; 95% CI, 1.2-22), risk factors for IACs were extended resection (OR, 5; 95% CI, 1.2-22) and main pancreatic duct diameter of 3 mm or less (OR, 2; 95% CI, 1.1-3), and the risk factor for pancreatic fistula was main pancreatic duct diameter of 3 mm or less (OR, 2.5; 95% CI, 1.2-4.6). CONCLUSIONS: Age more than 70 years, extended resections, and main pancreatic duct diameter less than 3 mm are independent risk factors that should be considered in indications for and techniques of pancreatoduodenectomy.

In vitro thermochemotherapy of colon cancer cell lines with irinotecan alone and combined with mitomycin C.

BACKGROUND/AIMS: Irinotecan (CPT-11) is a new drug of the camptothecin family which has shown significant activity in the treatment of metastatic colorectal cancer. Hyperthermia has been shown to enhance the cytotoxic effect of some anticancer drugs and has been combined with intraperitoneal chemotherapy for the treatment of colorectal peritoneal carcinomatosis. The purpose of this study was to evaluate the cytotoxic effect of CPT-11 alone and in combination with mitomycin C (MMC) and hyperthermia on three colorectal cancer cell lines: CACO-2, HT-29, and DHD/K12/TRb (PROb). METHODOLOGY: The cytotoxic effect of CPT-11 was tested at seven different concentrations (from 2.5 to 160microg/mL) for each type of cell line at 37, 39, 42.5 and 44 degrees C. Combined cytotoxic effect of MMC with CPT-11 was tested at 37 and 42.5 degrees C. RESULTS: The cytotoxic effect of CPT-11 alone increased with concentration (p<0.001) and with increasing temperature (p<0.001) at concentration above 5microg/mL in all three cell lines. CPT-11 (20microg/mL) significantly increased the cytotoxicity of MMC (8microg/mL) at 42.5 degrees C on the CACO-2 line. The combination of CPT-11 and MMC had at least 92% cytotoxicity on the three cell lines. CONCLUSIONS: The combination of CPT-11 and MMC at 42.5 degrees C had a large spectrum of cytotoxicity in these in vitro models. Our findings support the clinical use of this combination and provide a rationale for the design of a clinical trial using intraperitoneal chemohyperthermia with MMC and CPT-11 to treat colorectal peritoneal carcinomatosis of colorectal origin.

Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial.

HYPOTHESIS: Prophylactic administration of octreotide acetate decreases the rate of postoperative intra-abdominal complications (IACs) after elective pancreatic resection. DESIGN: Single-blind, controlled, randomized trial. SETTING: Multicenter (N = 20) trial in France. PATIENTS: Of 230 randomized patients undergoing pancreatoduodenectomy and pancreatic enteric anastomosis or distal pancreatectomy for either malignant or benign tumor or chronic pancreatitis, 122 were allotted intraoperatively to receive octreotide; 108 served as controls. RESULTS: All 230 patients were analyzed. Both groups were comparable except that significantly more patients in the octreotide group had biological glue injected into the main pancreatic duct alone (P<.001) or reinforcing the pancreatic enteric anastomosis (68% [83/122] vs 39% [42/108]; P =.002). Fewer patients (P =.08) in the octreotide group sustained 1 or more IACs (22% vs 32%). In subgroup analysis, octreotide significantly reduced the rate of patients sustaining 1 or more IACs when the main pancreatic duct diameter was less than 3 mm (P<.02), when pancreatojejunostomy was performed (P<.02), or both (P<.02). No significant differences were found regarding IAC severity. Twenty-three patients (10%) died postoperatively, 16 (70% of deaths) of whom had 1 or more IACs. The only independent risk factor for IACs found on multivariate analysis was pancreatoduodenectomy compared with distal pancreatectomy (P<.01) (odds ratio, 3.54 [95% confidence interval, 1.44-8.65]). CONCLUSIONS: Our results suggest that octreotide is not necessary for all patients undergoing pancreatic resection; it could be useful when the main pancreatic duct is less than 3 mm in diameter and when pancreatoduodenectomy is completed by pancreatojejunostomy.

Half of the currecnt practice of gastrointestinal surgery is against the evidence: a survery of the French Society of Digestive Surgery.

The French Society of Digestive Surgery conducted a survey among its members to assess whether or not the routine practice of gastrointestinal surgery is evidence based. The questionnaire included 13 questions focusing on several aspects of gastrointestinal surgery and for which strong evidence exists. The participants (n = 379) were asked to respond according to their usual practice. The response rate was 75%. Only 57% +/- 15% of the responses were in accordance with the evidence. That rate of evidence-based responses did not differ according to the age of participants but was higher at university hospitals (P = 0.05).

Randomized trial of adjuvant chemotherapy after curative resection for gastric cancer.

BACKGROUND: The aim of the study was to evaluate the efficacy of adjuvant chemotherapy on survival after resection for gastric cancer. METHODS: Patients were enrolled if they underwent resection of gastric cancer but had lymph node or serosal involvement or both. Surgical resection was either total or partial gastrectomy according to the site of the tumor, and surgeons were allowed to perform either D1 or D2 gastrectomy. The subjects were random assigned in two treatment groups as follows: surgery alone as the control group, or surgery and adjuvant chemotherapy. Nine cycles of 5 days protocol every 4 weeks was proposed to the patients of the chemotherapy group. The protocol included a daily administration of 200 mg/m(2) of folinic acid, 5-fluorouracil (375 mg/m(2) during the first session increasing 25 mg by session until reaching 500 mg/m(2)) and CDDP 15 mg/m(2). Two hundred patients were required. Kaplan-Meier survival curves were compared according to the log-rank and the Mantel-Haenszel methods. RESULTS: In all, 205 patients were enrolled in the study; 104 had surgery alone and 101 had surgery and adjuvant chemotherapy. The patients' characteristics were similar except for the mean age, which was 4 years less in the control group. Because of toxicity, 54% of the patients stopped the protocol before the end of the nine courses, and 46% of the patients received the nine courses including 32% with a decreased dose and 14% with a full dose. The 5-year survival rate was 39% in the control group and 39% in the chemotherapy group. CONCLUSIONS: This protocol of adjuvant chemotherapy failed to improve the 5-year survival after resection for gastric cancer.

Methodological index for non-randomized studies (minors): development and validation of a new instrument.

BACKGROUND: Because of specific methodological difficulties in conducting randomized trials, surgical research remains dependent predominantly on observational or non-randomized studies. Few validated instruments are available to determine the methodological quality of such studies either from the reader's perspective or for the purpose of meta-analysis. The aim of the present study was to develop and validate such an instrument. METHODS: After an initial conceptualization phase of a methodological index for non-randomized studies (MINORS), a list of 12 potential items was sent to 100 experts from different surgical specialties for evaluation and was also assessed by 10 clinical methodologists. Subsequent testing involved the assessment of inter-reviewer agreement, test-retest reliability at 2 months, internal consistency reliability and external validity. RESULTS: The final version of MINORS contained 12 items, the first eight being specifically for non-comparative studies. Reliability was established on the basis of good inter-reviewer agreement, high test-retest reliability by the kappa-coefficient and good internal consistency by a high Cronbach's alpha-coefficient. External validity was established in terms of the ability of MINORS to identify excellent trials. CONCLUSIONS: MINORS is a valid instrument designed to assess the methodological quality of non-randomized surgical studies, whether comparative or non-comparative. The next step will be to determine its external validity when used in a large number of studies and to compare it with other existing instruments.

Death during laparoscopy: can 1 gas push out another? Danger of argon electrocoagulation.

We report the death of a young man during a laparoscopic partial splenectomy performed with an argon plasma coagulator to remove a benign cyst. The report analyzes the very particular mechanism of a gas embolism, which caused death here. This analysis leads us to recommend a close attention on the use of argon coagulators during laparoscopy. The aim of this article is to draw surgeons' attention to the conclusions of a court-ordered expert assessment intended to elucidate the mechanisms responsible for the death of a 20-year-old man during a laparoscopic partial splenectomy performed with an argon plasma coagulator to remove a benign cyst.