Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.

BACKGROUND: Surgical site infections (SSIs) are common complications after colorectal surgery. Oral non-absorbable antibiotic prophylaxis (OAP) can be administered preoperatively to reduce the risk of SSIs. Its efficacy without simultaneous mechanical cleaning is unknown. METHODS: The Precaution trial was a double-blind, placebo-controlled randomized clinical trial conducted in six Dutch hospitals. Adult patients who underwent elective colorectal surgery were randomized to receive either a three-day course of preoperative OAP with tobramycin and colistin or placebo. The primary composite endpoint was the incidence of deep SSI or mortality within 30 days after surgery. Secondary endpoints included both infectious and non-infectious complications at 30 days and six months after surgery. RESULTS: The study was prematurely ended due to the loss of clinical equipoise. At that time, 39 patients had been randomized to active OAP and 39 to placebo, which reflected 8.1% of the initially pursued sample size. Nine (11.5%) patients developed the primary outcome, of whom four had been randomized to OAP (4/39; 10.3%) and five to placebo (5/39; 12.8%). This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78). In the per-protocol analysis, the relative risk was 0.64 (95% CI 0.12-3.46). CONCLUSIONS: Observational data emerging during the study provided new evidence for the effectiveness of OAP that changed both the clinical and medical ethical landscape for infection prevention in colorectal surgery. We therefore consider it unethical to continue randomizing patients to placebo. We recommend the implementation of OAP in clinical practice and continuing monitoring of infection rates and antibiotic susceptibilities. TRIAL REGISTRATION: The PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.

Laparoscopic sleeve gastrectomy with an extensive posterior mobilization: technique and preliminary results.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is becoming increasingly popular as a stand-alone procedure for the treatment of morbidly obese patients. A direct posterior approach to the angle of His was developed at our department to improve visualization of the difficult dissection of the short gastric vessels and to facilitate proper mobilization of the stomach around the left crus enabling safe realization of a tight sleeve. The technique and its preliminary results are described. METHODS: LSG by posterior approach was performed in a consecutive series of 445 (110 male/335 female, age 18-63 years, mean body mass index 46 kg/m(2) (range 35-76)) patients between 2007 and 2010. RESULTS: Weight loss defined as mean percent excess weight loss (%EWL) was 71% (±26%) at 1 year, 69% (±25%) at 2 years, and 55% (±27%) at 3 years. Sixteen patients (4%) developed postoperative intra-abdominal hematoma, 8 patients (2%) anastomotic leakage, and 6 patients intra-abdominal abscess (1%), requiring reoperation in 20 patients (4%). Five patients (1%) had pulmonary embolism. Thirty-day mortality rate was 0.2%. CONCLUSIONS: LSG by the posterior approach is a safe and effective procedure, enabling a tight sleeve formation leading to satisfactory %EWL results. Since long-term results of LSG are unknown, further studies are needed to define the exact place of the LSG as a stand-alone bariatric procedure.

Novel criteria for parathyroid hormone levels in parathyroid hormone-guided parathyroid surgery.

CONTEXT: Novel criteria for decrease of perioperative parathyroid hormone measurement may improve the accuracy of perioperative quick parathyroid hormone (qPTH)-guided parathyroidectomy. OBJECTIVE: To assess overall cure rate based on conventional criteria (50% decline of qPTH). Perioperative qPTH levels were evaluated to determine novel criteria for successful parathyroid surgery. DESIGN: Analysis of perioperative qPTH measurement findings of all consecutive patients undergoing parathyroidectomy for hyperparathyroidism (72 with primary hyperparathyroidism and 28 with secondary or tertiary hyperparathyroidism or multiple endocrine neoplasia I/IIa disease). RESULTS: Measurement of qPTH (based solely on the criterion of greater than 50% decline of parathyroid hormone) in 72 patients with primary hyperparathyroidism (77 procedures) showed true-positive results in 69, false-positive results in 4, and true-negative results in 4 procedures. In our series, false-positive and true-negative results were associated with high postexcision levels. However, when qPTH declines of greater than 70% and 80% were used in cases of postexcision qPTH levels of 100 to 200 ng/L and greater than 200 ng/L, respectively, no false-positive results were observed. CONCLUSIONS: Through adherence to these novel criteria, reexploration of the neck could have been prevented in 29% of patients with primary hyperparathyroidism due to multiple gland disease. These novel criteria demand future evaluation to establish their value.

Antidiuretic hormone release during laparoscopic donor nephrectomy.

BACKGROUND: During laparoscopic procedures, increased intra-abdominal pressure may cause transient renal dysfunction due to impaired renal blood flow and induction of neurohormones. However, the relationship between antidiuretic hormone (ADH) secretion and increased intra-abdominal pressure is poorly understood. HYPOTHESIS: Laparoscopic donor nephrectomy (LDN) is associated with an increase in plasma ADH concentration, which influences renal function in both the donor and transplanted graft. OBJECTIVES: To evaluate plasma ADH levels during LDN and to correlate ADH levels with graft function. DESIGN AND INTERVENTIONS: In 30 patients who underwent LDN, plasma ADH levels were collected before insufflation, during surgery, after desufflation, and 24 hours after the procedure. In 6 patients who had open donor nephrectomy, blood samples were obtained as controls. Furthermore, graft function, operative characteristics, and clinical outcome were compared. SETTING: University hospital. RESULTS: In the LDN group, mean ADH levels during pneumoperitoneum and 30 minutes postinsufflation were significantly higher compared with preinsufflation values (P<.001). Twenty-four hours after LDN, mean ADH levels had returned to normal values. There were no significant differences in ADH levels in the open donor nephrectomy group. No significant differences in either intraoperative diuresis, blood pressure readings, or postoperative graft function were documented among the 2 groups. CONCLUSIONS: In this study, LDN was associated with an increase in plasma ADH that appeared to be related to increased intra-abdominal pressure. We conclude that the increased ADH concentrations during LDN are not associated with clinically significant changes in either the kidney donor or the transplanted graft.