BACKGROUND: The purpose of the current study was to present the preliminary results of a randomized prospective trial comparing laparoscopic and open vertical banded gastroplasty (Mason's procedure). METHODS:From April 1995 to April 1996, 68 patients (9 men and 59 women, mean age, 36 years; ranges, 17-60 years) affected from morbid obesity (mean body weight, 123 kg; range, 89-188 kg; mean body mass index (BMI), 43 kg/m2; range, 37-66 kg/m2) were enrolled in a prospective trial and randomly assigned to a laparoscopic (group A) or open (group B) Mason's gastroplasty. There was no statistically significant difference between the two groups in terms of patient epidemiologic data. The significance level among the data was assessed by means of Fisher's exact test. RESULTS: The success of laparoscopic gastroplasty was 88.2% (30/34). The intervention was significantly longer in the laparoscopic group (150 min vs. 60 min; p = 0.001). No mortality was recorded in the overall population. Intraoperative complications included only one case of gastric bleeding in group A (2.9% vs. 0%; p value not significant [NS]). Early major complications ranged as high as 6.6% and 7.8%, respectively, in groups A and B (p = NS), and included one case of peritonitis and one case of pneumonia in group A, and two cases of peritonitis and one pulmonary embolism in group B. Early minor postoperative complications consisted of wound infections only, observed in one group A patient (3.3%) and four group B patients (10. 8%, p = 0.04). At longer follow-up, incisional hernias occurred in 15.8% (6/38) of patients surgically treated with a conventional approach compared with none among those successfully surgically treated with laparoscopic access (p = 0.04). No statistically significant difference was observed between the two groups regarding the efficacy of the procedure, in terms of decrease in percentage of excess body weight, mean body weight, or mean BMI. CONCLUSIONS: The preliminary results of current study show that the laparoscopic Mason procedure is a time-consuming and technically demanding operation, as effective as its traditional counterpart, but carrying a statistically significant decrease in the incidence of wound infections and incisional hernias.
RCT Entities:
BACKGROUND: The purpose of the current study was to present the preliminary results of a randomized prospective trial comparing laparoscopic and open vertical banded gastroplasty (Mason's procedure). METHODS: From April 1995 to April 1996, 68 patients (9 men and 59 women, mean age, 36 years; ranges, 17-60 years) affected from morbid obesity (mean body weight, 123 kg; range, 89-188 kg; mean body mass index (BMI), 43 kg/m2; range, 37-66 kg/m2) were enrolled in a prospective trial and randomly assigned to a laparoscopic (group A) or open (group B) Mason's gastroplasty. There was no statistically significant difference between the two groups in terms of patient epidemiologic data. The significance level among the data was assessed by means of Fisher's exact test. RESULTS: The success of laparoscopic gastroplasty was 88.2% (30/34). The intervention was significantly longer in the laparoscopic group (150 min vs. 60 min; p = 0.001). No mortality was recorded in the overall population. Intraoperative complications included only one case of gastric bleeding in group A (2.9% vs. 0%; p value not significant [NS]). Early major complications ranged as high as 6.6% and 7.8%, respectively, in groups A and B (p = NS), and included one case of peritonitis and one case of pneumonia in group A, and two cases of peritonitis and one pulmonary embolism in group B. Early minor postoperative complications consisted of wound infections only, observed in one group A patient (3.3%) and four group B patients (10. 8%, p = 0.04). At longer follow-up, incisional hernias occurred in 15.8% (6/38) of patients surgically treated with a conventional approach compared with none among those successfully surgically treated with laparoscopic access (p = 0.04). No statistically significant difference was observed between the two groups regarding the efficacy of the procedure, in terms of decrease in percentage of excess body weight, mean body weight, or mean BMI. CONCLUSIONS: The preliminary results of current study show that the laparoscopic Mason procedure is a time-consuming and technically demanding operation, as effective as its traditional counterpart, but carrying a statistically significant decrease in the incidence of wound infections and incisional hernias.
Authors: Juan C Rodríguez-Sanjuán; Marcos Gómez-Ruiz; Soledad Trugeda-Carrera; Carlos Manuel-Palazuelos; Antonio López-Useros; Manuel Gómez-Fleitas Journal: World J Gastroenterol Date: 2016-02-14 Impact factor: 5.742
Authors: S Sauerland; L Angrisani; M Belachew; J M Chevallier; F Favretti; N Finer; A Fingerhut; M Garcia Caballero; J A Guisado Macias; R Mittermair; M Morino; S Msika; F Rubino; R Tacchino; R Weiner; E A M Neugebauer Journal: Surg Endosc Date: 2004-12-02 Impact factor: 4.584
Authors: Attila Csendes; Patricio Burdiles; Karin Papapietro; Juan Carlos Diaz; Fernando Maluenda; Ana Burgos; Jorge Rojas Journal: J Gastrointest Surg Date: 2005-01 Impact factor: 3.452