OBJECTIVE: In this study, we evaluated the short-term outcomes following three-dimensional (3D) or two-dimensional (2D) laparoscopic surgery for patients with gastric cancer. BACKGROUND: There is a lack of prospective evidence regarding the safety and efficacy of 3D versus 2D laparoscopic surgery for patients with gastric cancer. Therefore, we conducted a phase III single-center, prospective, randomized, controlled trial to compare 3D and 2D laparoscopic surgery for patients with gastric cancer. METHODS: We compared operation time, intraoperative blood loss, number of lymph node dissections, morbidity, and mortality between the 3D and 2D groups following laparoscopic surgery for gastric cancer. The study is registered at ClinicalTrials.gov with ID number NCT02327481. RESULTS: A total of 228 patients were randomized (3D group 115 cases; 2D group 113 cases) between January 1, 2015 and September 1, 2015. Seven patients who underwent exploratory operations were excluded. Finally, a total of 221 patients were analyzed (3D group 109 cases, 2D group 112 cases). There were no significant differences between the two groups regarding the clinical pathological characteristics, operating time (3D vs. 2D, 184 ± 36 vs. 178 ± 37 min, P = 0.288), number of lymph node dissections (36 ± 14 vs. 37 ± 13, P = 0.698), time to first ambulation (2.27 ± 1.60 vs. 2.04 ± 0.84, P = 0.18), flatus (3.89 ± 1.49 vs. 3.69 ± 1.12, P = 0.255), liquid diet (4.88 ± 1.88 vs. 4.79 ± 1.57, P = 0.684), or duration of postoperative hospital stay (12.52 ± 4.83 vs. 12.63 ± 7.32, P = 0.903). The postoperative complication rates of the 3D and 2D groups were 18.3 and 16.1%, respectively, P = 0.723. No patients died during the postoperative hospital stay. However, the intraoperative blood loss in the 3D group was significantly lower than the 2D group (58 ± 75vs. 78 ± 72 ml, P = 0.047). CONCLUSION: There was no significant difference in operation time and number of lymph node harvested between the 3D and 2D groups; however, 3D laparoscopic surgery may reduce the intraoperative blood loss compared to 2D procedure. Therefore, we conclude that this trial is safe and is thus ongoing.
RCT Entities:
OBJECTIVE: In this study, we evaluated the short-term outcomes following three-dimensional (3D) or two-dimensional (2D) laparoscopic surgery for patients with gastric cancer. BACKGROUND: There is a lack of prospective evidence regarding the safety and efficacy of 3D versus 2D laparoscopic surgery for patients with gastric cancer. Therefore, we conducted a phase III single-center, prospective, randomized, controlled trial to compare 3D and 2D laparoscopic surgery for patients with gastric cancer. METHODS: We compared operation time, intraoperative blood loss, number of lymph node dissections, morbidity, and mortality between the 3D and 2D groups following laparoscopic surgery for gastric cancer. The study is registered at ClinicalTrials.gov with ID number NCT02327481. RESULTS: A total of 228 patients were randomized (3D group 115 cases; 2D group 113 cases) between January 1, 2015 and September 1, 2015. Seven patients who underwent exploratory operations were excluded. Finally, a total of 221 patients were analyzed (3D group 109 cases, 2D group 112 cases). There were no significant differences between the two groups regarding the clinical pathological characteristics, operating time (3D vs. 2D, 184 ± 36 vs. 178 ± 37 min, P = 0.288), number of lymph node dissections (36 ± 14 vs. 37 ± 13, P = 0.698), time to first ambulation (2.27 ± 1.60 vs. 2.04 ± 0.84, P = 0.18), flatus (3.89 ± 1.49 vs. 3.69 ± 1.12, P = 0.255), liquid diet (4.88 ± 1.88 vs. 4.79 ± 1.57, P = 0.684), or duration of postoperative hospital stay (12.52 ± 4.83 vs. 12.63 ± 7.32, P = 0.903). The postoperative complication rates of the 3D and 2D groups were 18.3 and 16.1%, respectively, P = 0.723. No patients died during the postoperative hospital stay. However, the intraoperative blood loss in the 3D group was significantly lower than the 2D group (58 ± 75 vs. 78 ± 72 ml, P = 0.047). CONCLUSION: There was no significant difference in operation time and number of lymph node harvested between the 3D and 2D groups; however, 3D laparoscopic surgery may reduce the intraoperative blood loss compared to 2D procedure. Therefore, we conclude that this trial is safe and is thus ongoing.
Entities:
Keywords:
3D Laparoscopic gastrectomy; Gastric cancer; Randomized, controlled trial
Authors: B Alaraimi; W El Bakbak; S Sarker; S Makkiyah; A Al-Marzouq; R Goriparthi; A Bouhelal; V Quan; B Patel Journal: World J Surg Date: 2014-11 Impact factor: 3.352
Authors: Alberto Arezzo; Nereo Vettoretto; Nader K Francis; Marco Augusto Bonino; Nathan J Curtis; Daniele Amparore; Simone Arolfo; Manuel Barberio; Luigi Boni; Ronit Brodie; Nicole Bouvy; Elisa Cassinotti; Thomas Carus; Enrico Checcucci; Petra Custers; Michele Diana; Marilou Jansen; Joris Jaspers; Gadi Marom; Kota Momose; Beat P Müller-Stich; Kyokazu Nakajima; Felix Nickel; Silvana Perretta; Francesco Porpiglia; Francisco Sánchez-Margallo; Juan A Sánchez-Margallo; Marlies Schijven; Gianfranco Silecchia; Roberto Passera; Yoav Mintz Journal: Surg Endosc Date: 2018-12-04 Impact factor: 4.584