Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis.

BACKGROUND: Anastomotic leakage is a potential major complication after colorectal surgery. The C-seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal leakage in case of anastomotic dehiscence. The C-seal trial was initiated to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses. METHODS: This RCT was performed in 41 hospitals in the Netherlands, Germany, France, Hungary and Spain. Patients undergoing elective surgery with a stapled colorectal anastomosis less than 15 cm from the anal verge were eligible. Included patients were randomized to the C-seal and control groups, stratified for centre, anastomotic height and intention to create a defunctioning stoma. Primary outcome was anastomotic leakage requiring invasive treatment. RESULTS: Between December 2011 and December 2013, 402 patients were included in the trial, 202 in the C-seal group and 200 in the control group. Anastomotic leakage was diagnosed in 31 patients (7·7 per cent), with a 10·4 per cent leak rate in the C-seal group and 5·0 per cent in the control group (P = 0·060). Male sex showed a trend towards a higher leak rate (P = 0·055). Construction of a defunctioning stoma led to a lower leakage rate, although this was not significant (P = 0·095). CONCLUSION: C-seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number: NTR3080 (http://www.trialregister.nl/trialreg/index.asp).

Late anastomotic leakage in colorectal surgery: a significant problem.

AIM: Reported incidence rates of colorectal anastomotic leakage (AL) vary between 2.5 and 20%. There is little information on late anastomotic leakage (LAL). The aim of this study was to determine the incidence of LAL after colorectal resection. METHOD: All patients undergoing colorectal resection with primary anastomosis between January 2004 and October 2009 at the University Medical Center Groningen were included. LAL was defined as anastomotic leakage diagnosed more than 30 days after surgery. RESULTS: One hundred and forty-one patients were analysed. Indications for surgery included both benign and malignant conditions. The incidence of early anastomotic leakage (EAL) within 30 days after surgery was 13%. The LAL rate was 6%. Eighty-nine per cent of patients with EAL underwent relaparotomy compared with 44% for LAL (P = 0.02). CONCLUSION: One-third of all anastomotic leakages were diagnosed more than 30 days after surgery. Of these, 44% underwent relaparotomy. Patients with leakage diagnosed within 30 days after surgery were more likely to undergo relaparotomy. LAL is a significant problem after colorectal surgery.

Documenting correct assessment of biliary anatomy during laparoscopic cholecystectomy.

BACKGROUND: Correct assessment of biliary anatomy can be documented by photographs showing the "critical view of safety" (CVS) but also by intraoperative cholangiography (IOC). METHODS: Photographs of the CVS and IOC images for 63 patients were presented to three expert observers in a random and blinded fashion. The observers answered questions pertaining to whether the biliary anatomy had been conclusively documented. RESULTS: The CVS photographs were judged to be "conclusive" in 27%, "probable" in 35%, and "inconclusive" in 38% of the cases. The IOC images performed better and were judged to be "conclusive" in 57%, "probable" in 25%, and "inconclusive" in 18% of the cases (P < 0.001 compared with the photographs). The observers indicated that they would feel comfortable transecting the cystic duct based on the CVS photographs in 52% of the cases and based on the IOC images in 73% of the cases (P = 0.004). The interobserver agreement was moderate for both methods (kappa values, 0.4-0.5). For patients with a history of cholecystitis, both the CVS photographs and the IOC images were less frequently judged to be sufficient for transection of the cystic duct (P = 0.006 and 0.017, respectively). CONCLUSION: In this series, IOC was superior to photographs of the CVS for documentation of the biliary anatomy during laparoscopic cholecystectomy. However, both methods were judged to be conclusive only for a limited proportion of patients, especially in the case of cholecystitis. This study highlights that documenting assessment of the biliary anatomy is not as straightforward as it seems and that protocols are necessary, especially if the images may be used for medicolegal purposes. Documentation of the biliary anatomy should be addressed during training courses for laparoscopic surgery.

Surgeon-performed ultrasound as preoperative localization study in patients with primary hyperparathyroidism.

BACKGROUND: Minimally invasive parathyroidectomy is the treatment of choice for single-gland primary hyperparathyroidism. However, the exact location of the abnormal gland has to be established. Sestamibi scintigraphy, computed tomography and ultrasound (US) are commonly used modalities. We describe our experience in a non-academic center with surgeon-performed US (S-US) of the neck as preoperative localization study in patients with primary hyperparathyroidism (PHPT). METHODS: Patients with a biochemically proven diagnosis of PHPT and preoperative S-US were included. Data were recorded prospectively. Perioperative gland location was compared to the preoperative S-US to determine sensitivity, specificity and accuracy rates. RESULTS: Two of the 50 patients who underwent S-US were not subjected to surgery. In 85% of the patients analyzed by S-US, the appropriate abnormal gland(s) were identified. In 11%, no gland was identified, but abnormal glands were found during surgery. Sensitivity of S-US in our hospital is 85%, with a positive predictive value of 97%. CONCLUSIONS: We achieved a satisfactory sensitivity rate. S-US provides anatomic information to the surgeon which enables a more detailed operation planning, and it is a valuable diagnostic modality for patients with PHPT in our opinion. We hope that our data encourage other centers to implement this technique as well.

Intra-operative parathyroid hormone measurements - experience of a non-academic hospital.

BACKGROUND: Surgery is the treatment of choice for symptomatic primary hyperparathyroidism. The majority of research concerning intra-operative parathyroid hormone (ioPTH) measurements is conducted in university hospitals. Whether ioPTH measurements are feasible and useful in predicting the presence of remaining hyperfunctioning parathyroid tissue in a non-academic hospital remains uncertain. METHODS: Data were collected on all patients with biochemically proven and surgically treated primary hyperparathyroidism treated at the Reinier de Graaf Hospital from August 2002 to December 2007. RESULTS: Sixty-five patients were included. The mean pre-operative serum calcium level was 2.78 mmol/l (range 2.28 - 3.80 mmol/l, normal range 2.20 - 2.65 mmol/l) and the mean serum parathyroid hormone level 17.0 pmol/l (range 4.0 - 90.3 pmol/l, normal range 1.0 - 5.5 pmol/l). All patients were operated on for primary hyperparathyroidism, using ioPTH measurements during their first operation. Sensitivity and specificity rates of ioPTH measurements were 98% and 89%, respectively. The ioPTH test accurately indicated incomplete removal of all hyperfunctioning parathyroid tissue in 8 patients (12%). Five patients (8%) were re-explored immediately, of whom 4 were successfully treated in this single operative session. One patient was operated on successfully the next day. Two patients were operated on with a successful result during a second admission. In all the ioPTH measurements there was 1 false-positive result (1.5%) and 1 false-negative result (1.5%). The mean postoperative calcium value for the successfully treated patients was 2.34 mmol/l (range 2.14 - 2.71 mmol/l, normal range 2.20 - 2.65 mmol/l). The mean postoperative PTH level for the successfully treated patients was 3.76 pmol/l (range 0.40 - 7.1 pmol/l). CONCLUSION: Our data suggest that ioPTH measurements are feasible and useful in a non-academic hospital.