Background Anastomotic leakage of pancreaticojejunostomy (PJ) remains the single most important source of morbidity after pancreaticoduodenectomy (PD). The primary aim of this randomized clinical trial comparing PG with PJ after PD was to test the hypothesis that invaginated PG would result in a lower rate and severity of pancreatic fistula. Methods Patients undergoing PD were randomized to receive either a duct‐to‐duct PJ or a double‐layer invaginated PG. The primary endpoint was the rate of pancreatic fistula, using the definition of the International Study Group on Pancreatic Fistula. Secondary endpoints were the evaluation of severe abdominal complications (Clavien–Dindo grade IIIa or above), endocrine and exocrine function. Results Of 123 patients randomized, 58 underwent PJ and 65 had PG. The incidence of pancreatic fistula was significantly higher following PJ than for PG (20 of 58 versus 10 of 65 respectively; P = 0·014), as was the severity of pancreatic fistula (grade A: 2 versus 5 per cent; grade B–C: 33 versus 11 per cent; P = 0·006). The hospital readmission rate for complications was significantly lower after PG (6 versus 24 per cent; P = 0·005), weight loss was lower (P = 0·025) and exocrine function better (P = 0·022). Conclusion The rate and severity of pancreatic fistula was significantly lower with this PG technique compared with that following PJ. Registration number: ISRCTN58328599 (http://www.controlled-trials.com).
1 February 2004 in Journal of Laparoendoscopic & Advanced Surgical Techniques
Background: Thyroid surgery technique has undergone very few changes in the last century. The UltraCision® harmonic scalpel (UHS) (Smithfield, RI) has been widely used in laparoscopic surgery and is documented to be safe and fast for cutting and coagulating tissue. We studied whether the use of the UHS could have advantages in thyroid surgery in terms of operative time, length of hospitalization, morbidity, and general costs. Method: Our study was a prospective randomized trial of thyroidectomies and lobectomies performed for benign thyroid diseases in an endocrine surgery unit between February 2001 and July 2002. Patients were randomized in two groups: group A (n = 100) underwent thyroidectomy using UHS and group B (n = 100) with the conventional clamp-and-tie technique. Main outcome measures were demographics, operating time, length of hospitalization, intra- and postoperative complications, sequelae, and general costs. We used the unpaired 2-tailed Student's t test and the χ2 test to compare the series. Results: The two groups were similar in age and sex. Mean ± SD operative time was shorter in the UHS group compared with the conventional technique group for both lobectomy (61 ± 06 vs. 78 ± 10 minutes) and total thyroidectomy (86 ± 20 vs. 101 ± 16 minutes). Length of hospitalization was similar in both groups (1.07 vs. 1.15 days). We did not find statistical differences between the two techniques regarding transient postoperative complications. There were no deaths, no blood transfusions, no intraoperative complications, and no postoperative definitive sequelae. The global charges for every patient were significantly less in the UHS group (985.77 ± 107.08 euro vs. 1148.40 ± 153.25 euro). Conclusion: The use of ultrasonically activated shears resulted in a reduction of 15-20% in operative time and was cost-effective compared to the conventional technique group.