Selected article for: "animal study and sample size"

Author: Najah, Haythem; Lo Dico, Réa; Grienay, Marion; Dohan, Anthony; Dray, Xavier; Pocard, Marc
Title: Single-incision flexible endoscopy (SIFE) for detection and staging of peritoneal carcinomatosis.
  • Cord-id: winp41zz
  • Document date: 2016_1_1
  • ID: winp41zz
    Snippet: OBJECTIVE To show the feasibility and the safety of peritoneal carcinomatosis (PC) evaluation by single-incision flexible endoscopy (SIFE) and to compare it to single-incision rigid endoscopy (SIRE). BACKGROUND Direct peritoneal visualization, either by laparotomy or laparoscopy, continues to be the gold standard in diagnosing PC. We reported, in animal study, that combining single-incision laparoscopic surgery and flexible endoscopy improved evaluation of the peritoneal cavity in a live porcine
    Document: OBJECTIVE To show the feasibility and the safety of peritoneal carcinomatosis (PC) evaluation by single-incision flexible endoscopy (SIFE) and to compare it to single-incision rigid endoscopy (SIRE). BACKGROUND Direct peritoneal visualization, either by laparotomy or laparoscopy, continues to be the gold standard in diagnosing PC. We reported, in animal study, that combining single-incision laparoscopic surgery and flexible endoscopy improved evaluation of the peritoneal cavity in a live porcine model and in four human cadavers. METHODS Patients, undergoing surgical exploration for diagnosis and staging of PC, were included in a prospective study. Using a superiority design a sample size of 47 patients was determined. Through a single incision, a standardized peritoneoscopy was conducted with rigid (SIRE) and with flexible endoscope (SIFE). Primary outcome was the access success rates for the 13 regions of the Peritoneal Carcinomatosis Index (PCI). RESULTS Overall access to the 13 regions of PCI was successful in 83 % of the cases with SIRE and in 91.1 % with SIFE (p < 10(-10)). SIFE access rates were superior to SIREs' in the regions: R1 (87.2 vs. 61.7 %, p = 0.002), R2 (87.2 vs. 66 %, p = 0.004), R3 (85.1 vs. 59.6 %, p = 0.001) and R6 (80.9 vs. 61.7 %, p = 0.008). The mean PCI was higher (p < 10(4)) with SIFE 12.77 (±11.97) than with SIRE 11.77 (±11.63). CONCLUSION This prospective, comparative study shows that SIFE was significantly superior to SIRE in the exploration of some difficult-to-access peritoneal areas, located in regions 1, 2, 3 and 6. These two minimally invasive staging procedures are safe, feasible and have to be seen as complementary rather than competing.

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