Description of Event or Problem · 1
THIS WAS A SPONTANEOUS REPORT RECEIVED FROM THE LITERATURE ARTICLE ENTITLED: LAPAROSCOPY SLEEVE GASTRECTOMY: 220 CASES IN A COMPARATIVE STUDY WITH THREE BUTTRESSING METHODS APPLIED ON STAPLER LINE; VALENTI A, RIVKIN E, CARANDINA S, STEIGER A, POLLARD C, RIZK N, ET AL.; OBES SURG; 23:1017-1243:1053. THE GOALS OF THIS PROSPECTIVE NON-RANDOMIZED STUDY WAS TO COMPARE THREE TECHNIQUES OF REINFORCING THE STAPLE LINE (SL) AND TO ANALYZE THE RESULTS IN TERMS OF POSTOPERATIVE LEAKS. BETWEEN JAN-2010 AND JAN-2012, 220 CONSECUTIVE NON-RANDOMIZED PATIENTS UNDERWENT A SLEEVE GASTRECTOMY. THERE WERE THREE GROUPS ENROLLED: GROUP A WAS SUTURING WITH A X OF TYPE 1 STEAK (MONOCRYL 2/0), GROUP B WAS SUTURING WITH AN OVERSEWING OF TYPE 2 STEAK (V-LOC 90) AND GROUP C WAS (SL) GLUE VAPORIZATION WITH HUMAN CLOTTABLE PROTEIN/HUMAN THROMBIN SPRAYED VIA OMRIX PRESSURE REGULATOR. BETWEEN 60 AND 80 PATIENTS (GENDER UNSPECIFIED) WERE INCLUDED IN GROUP C AND RECEIVED HUMAN CLOTTABLE PROTEIN/HUMAN THROMBIN; SOLUTION 2 5 ML SPRAY FOR STAPLE LINE GLUE VAPORIZATION (TISSUE SEALING; OFF LABEL USE). THE PATIENTS IN GROUP C HAD A BODY MASS INDEX WAS 44.1 (KG/M2) PLUS OR MINUS 6.6, AGE WAS 35.7 PLUS OR MINUS 9.5. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON UNSPECIFIED DATES 6.25 PERCENT OF THE PATIENTS IN THE HUMAN CLOTTABLE PROTEIN/HUMAN THROMBIN SPRAYED VIA OMRIX PRESSURE REGULATOR GROUP C DEVELOPED FISTULAS. TREATMENT FOR THE FISTULAS WAS NOT SPECIFIED. THE ACTION TAKEN WITH HUMAN CLOTTABLE PROTEIN/HUMAN THROMBIN SPRAYED VIA OMRIX PRESSURE REGULATOR IN RESPONSE TO THE EVENTS WAS UNSPECIFIED. THE PATIENT OUTCOMES FOR FISTULA AND OFF LABEL USE WERE NOT PROVIDED. THIS REPORT IS SERIOUS (MEDICALLY SIGNIFICANT). (B)(4).