The aim of this paper is to present the results of the Italian Society of Colorectal Surgery [or SocietA Italiana di Chirurgia Colorettale (SICCR)] logbook of Adverse Events (AE) occurring in relation to Emerging Technologies in Coloproctology (ETCs), over a 3-year period. A total of 245 AE were reported (patients age: mean = 49.6 years, range = 20-75 years; Gender: 155 = F, 90 = M). The "observations" originated from the same institution of the AEs in 44 cases (18.0 %), while 201 patients (82.0 %) had been operated on somewhere else. The three most reported ETCs were: Procedure for Prolapsed Haemorrhoids (PPHA (R)) (n = 120-48.9 %), Stapled Transanal Rectal Resection (STARR(A (R))) (n = 96-39.2 %), and Transanal Haemorrhoidal Dearterialization (THDA (R)) (n = 11-4.5 %). PPHA (R), STARR(A (R)), and THDA (R) together accounted for n = 227 (92.6 %) observations. For the three main reported ETCs, the various AEs are listed. Chronic pain after PPHA (R) was 46/120 (38.3 %), and after STARR(A (R)) of 21/96 (21.9 %). The overall re-operation rate was n = 135 (55.1 %) versus n = 110 (44.9 %) no reoperation. In particular, for the three main reported ETCs, n = 68/120 (56.7 %) following an AE after PPHA (R), n = 47/94 (50.0 %) following an AE after STARR(A (R)), and n = 6/11 (54.5 %) following an AE post-THDA (R). The various types of treatment to solve AE after each of the three most observed ETCs are reported in the text. Our results do not allow us to draw statistical conclusions; however, this was not the aim of our survey. ETCs are important, yet they are not without major risks. Manufacturers should help colorectal surgeons to convey the right message to patients.

Emerging technologies in coloproctology: results of the Italian Society of Colorectal Surgery Logbook of Adverse Events

DODI, GIUSEPPE;
2012

Abstract

The aim of this paper is to present the results of the Italian Society of Colorectal Surgery [or SocietA Italiana di Chirurgia Colorettale (SICCR)] logbook of Adverse Events (AE) occurring in relation to Emerging Technologies in Coloproctology (ETCs), over a 3-year period. A total of 245 AE were reported (patients age: mean = 49.6 years, range = 20-75 years; Gender: 155 = F, 90 = M). The "observations" originated from the same institution of the AEs in 44 cases (18.0 %), while 201 patients (82.0 %) had been operated on somewhere else. The three most reported ETCs were: Procedure for Prolapsed Haemorrhoids (PPHA (R)) (n = 120-48.9 %), Stapled Transanal Rectal Resection (STARR(A (R))) (n = 96-39.2 %), and Transanal Haemorrhoidal Dearterialization (THDA (R)) (n = 11-4.5 %). PPHA (R), STARR(A (R)), and THDA (R) together accounted for n = 227 (92.6 %) observations. For the three main reported ETCs, the various AEs are listed. Chronic pain after PPHA (R) was 46/120 (38.3 %), and after STARR(A (R)) of 21/96 (21.9 %). The overall re-operation rate was n = 135 (55.1 %) versus n = 110 (44.9 %) no reoperation. In particular, for the three main reported ETCs, n = 68/120 (56.7 %) following an AE after PPHA (R), n = 47/94 (50.0 %) following an AE after STARR(A (R)), and n = 6/11 (54.5 %) following an AE post-THDA (R). The various types of treatment to solve AE after each of the three most observed ETCs are reported in the text. Our results do not allow us to draw statistical conclusions; however, this was not the aim of our survey. ETCs are important, yet they are not without major risks. Manufacturers should help colorectal surgeons to convey the right message to patients.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11577/3104106
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