Tuesday, January 8, 2013

Some topics doing worthwhile randomized control trials

The long term results of the CLASSIC trial have recently become available showing the superiority of Laparoscopic Colon resection over open surgery.
We are listing certain topics in which no RCTs have been done till now and which will answer some interesting questions

1. RCT in pseudocyst pancreas comparing laparoscopic cyst enterostomy with open procedures

Saturday, January 5, 2013

Primary Surgery for perforated colonic diverticulitis against Hartmann's Procedure. multicentre Control trial

This paper was published in Annals of surgery in November 2012. This is a first randomized trial involving multiple centers which has shown improved outcome for primary anastomoses with diverting ileostomy after primary resection for perforated colon diverticulum.

Sixty-two patients with acute left-sided colonic perforation (Hinchey III and IV) from 4 centers were randomized to Hartman Procedure  (n = 30) and to Primary Anastomoses  (with diverting ileostomy, n = 32), with a planned stoma reversal operation after 3 months in both groups. Data were analyzed on an intention-to-treat basis. The primary end point was the overall complication rate. The study was discontinued following an interim analysis that found significant differences of relevant secondary end points as well as a decreasing accrual rate
Link to the abstract

Conclusion: This trial favours Primary Anastomoses

Our thoughts:
This study shows that the initial mortality, morbidity rates for the two procedures remain the same. However  more patients in the primary anastomoses group undergo stoma reversal as compared to Hartman's Procedure. This is a fact which has been known from previous studies. In the earlier studies it was thought that the sicker patients undergo Hartman's Procedure as compared to healthier patients that's why this discrepancy occurs but this randomized trials effectively proves the otherwise.

Saturday, February 12, 2011

Sunitinib improves outcomes in advanced pancreatic neuroendocrine tumors

Sunitinib is a tyrosine kinase inhibitor and also inhibits VEGF and PGF improves survival in advanced pancreatic neuroendocrine tumors.

Feb 2011 NEJM

The trial had 171 patients with advanced disease, The patients were randomized to receive placebo or Sunitinib. The study was stopped early when the benefits of Sunitinib were realized.

Progression free survival of Sunitinib was 11.4 months and placebo 5 months

10% of the patients in Sunitinib group died and 25% in pacebo group. Hazard ratio 0.4%