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

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

The role of PCR in the diagnosis and management of CMV in solid organ recipients: what is the predictive value for the development of disease and should PCR be used to guide antiviral therapy?

Cytomegalovirus remains a significant source of morbidity and mortality in immunocompromised hosts. The increased sensitivity of molecular diagnostic techniques (PCR, antigenemia) has resulted in our ability to detect viral replication earlier in the posttransplant period, before the onset of symptoms. With the advent of effective antiviral therapy, "preemptive therapy," guided by sensitive, early and specific predictors of CMV disease, has become a realistic objective. Although multiple studies have analyzed the sensitivity and specificity of these tests, their predictive value for the development of disease has not been defined. The purpose of this study was to evaluate the predictive value of a positive CMV PCR in the setting of solid abdominal organ transplantation. A total of 476 PCR assays were performed on 134 transplant recipients (102 kidney, 19 kidney/pancreas, 11 liver, 2 other) either as protocol serial samples or as dictated by clinical events. All samples were concomitantly analyzed using standard virological assays for CMV including culture, shell vial, and serology. Patients with any CMV seropositive donor/recipient (D/R) combination received ganciclovir prophylaxis in conjunction with antilymphocyte induction for 14 days. No subsequent CMV prophylaxis was used. The positive predictive value was 55% in all seropositive donor/recipient combinations. The highest risk group (seronegative recipient of seropositive donor) showed the highest positive predictive value, whereas seropositive recipients of either seropositive or seronegative donors showed positive predictive values of 45% and 25%, respectively. Negative predictive value was 100% for all groups. Early detection of CMV infection has important implications for patient management, including preemptive therapy, which can be guided by PCR, especially in high risk (D+/R-) patients.

Cholecystokinin increases bile acid synthesis with total parenteral nutrition but does not prevent stone formation.

Total parenteral nutrition (TPN) is associated with cholestasis and gallstones. Gallbladder stasis may be important in the development of gallstones, and cholecystokinin (CCK) to stimulate gallbladder contraction has been proposed as a treatment to prevent this complication. We studied in vivo bile acid synthesis and bile acid output in miniswine on TPN to test whether daily CCK improves bile acid output and normalizes bile acid profiles with TPN. Nine miniswine were nutritionally maintained with TPN for 4 weeks; four pigs received CCK (0.1 mg/kg) iv daily. In vivo bile acid synthesis was measured with injection of 7 alpha-tritiated cholesterol. An increase in tritiated water reflects the activity of 7 alpha-hydroxylation, the rate-limiting step in bile acid synthesis. At the end of 4 weeks, bile was collected and bile acid output and bile salt profiles were determined. One of five animals on TPN developed gallstones while two of four receiving daily CCK developed stones. In vivo bile acid synthesis decreased with TPN (controls, 63 +/- 9 mg/24 hr versus TPN, 13 +/- 4 mg/24 hr) and increased in TPN animals with CCK treatment (TPN-CCK, 105 +/- 35 mg/24 hr). Bile acid profiles are changed with TPN with more secondary bile acids, this was not improved with CCK. CCK improved bile acid synthesis and bile acid output but failed to prevent gallstone formation or normalize bile salt profiles. In addition to promoting gallbladder contraction, CCK may have a stimulatory effect on bile acid synthesis. CCK alone did not prevent gallstone formation.

Intrarectal ultrasonography in the staging and management of rectal tumors.

Intrarectal ultrasonography (IRUS) was used in the preoperative staging of 17 patients with rectal neoplasms. Fourteen patients had biopsy proven adenocarcinoma, and three others had large villous adenomas. Comparisons were made between clinical examination, IRUS staging and subsequent histopathologic staging. IRUS was performed with a Bruel and Kjaer radial scanner, type 1849, equipped with a 7.0 MHz transducer. IRUS accurately staged 3/3 rectal villous adenomas, and 11/13 rectal adenocarcinomas compared with histopathology. Clinical exam correctly staged all three villous tumors, and 6/9 carcinomas (24% of lesions were not palpable). IRUS correctly diagnosed the status of regional nodes in 88% of patients. IRUS is a highly accurate preoperative staging tool for rectal cancers both in delineating depth of bowel wall invasion and in assessing regional lymph nodes. It is easy to perform, safe, and well tolerated by the patients. IRUS has definitely arrived as the state of the art in evaluating rectal neoplasms and may impact heavily on surgical decision making for these neoplasms.

Exposure and manipulation of rectal lesions.

The methods of treatment for benign tumors of the rectum are by local removal or local destruction. The benign status of the tumor must be determined histologically or by gross morphology before treatment is instituted. The approaches are either transanal or by posterior proctotomy. The following procedures have been employed with excellent results for the past 30 years at the Ferguson Clinic: (1) transanally, by local excision, local destruction, or snare removal; and (2) by the posterior proctotomy approach for benign tumors that could not be removed transanally because of size or inaccessibility. A "two scope technique" first devised in 1969 has been used with great success since.

Lymphocyte blastogenic responses to allogeneic leukocytes and autochthonous tumor cells in colorectal carcinoma.

The blastogenic reactivity of peripheral blood lymphocytes (PBL) and mesenteric lymph node lymphocytes (LNL) against normal allogeneic leukocytes and autochthonous colorectal carcinoma cells is evaluated in 36 patients, and correlated with the patient's Dukes classification. Mesenteric LNL react significantly better than PBL to allogeneic leukocytes in both Dukes B and C (p less than 0.05). There are too few patients in Dukes A and D to permit statistical evaluation but the trend is the same. By contrast, LNL fail to react to autochthonous tumor cells in all classes, except in a few Dukes B patients. The proportion of PBL reactivity to autochthonous tumor cells seems to increase for Dukes C and D. It is possible that specific lymphocyte reactivity in colorectal carcinoma may be related to the antigenicity and immunogenicity of the tumor.

Treatment of benign tumours of the rectum.

The methods of treatment for benign tumours of the rectum are by local removal or local destruction. The benign status of the tumour must be determined histologically or by gross morphology before treatment is instituted. The approaches are either transanal or by posterior proctotomy. The following procedures have been employed with excellent results for the past thirty years at the Ferguson Clinic: 1. Transanally, by local excision, local destruction or snare removal. 2. By the posterior proctotomy approach for benign tumours that could not be removed transanally because of size or inaccessibility. A new 'Two scope technique' first devised in 1969 has been used with great success since.