Yoshiro Taguchi1, Shunichiro Komatsu2,3, Eiji Sakamoto2, Shinji Norimizu2, Yuji Shingu2, Hiroshi Hasegawa2. 1. Department of Digestive Surgery, Nagoya Daini Red Cross Hospital, 2-9, Myoken-cho, Showa-ku, Nagoya, 466-8650, Japan. yoshirotaguchi@hotmail.com. 2. Department of Digestive Surgery, Nagoya Daini Red Cross Hospital, 2-9, Myoken-cho, Showa-ku, Nagoya, 466-8650, Japan. 3. Department of Gastroenterological Surgery, Aichi Medical University, Nagakute, Aichi, Japan.
Abstract
BACKGROUND: The aim of this study was to assess whether laparoscopic appendectomy (LA) for complicated appendicitis (CA) effectively reduces the incidence of postoperative complications and improves various measurements of postoperative recovery in adults compared with open appendectomy (OA). METHODS: This single-center, randomized controlled trial was performed in the Nagoya Daini Red Cross Hospital. Patients diagnosed as having CA with peritonitis or abscess formation were eligible to participate and were randomly assigned to an LA group or an OA group. The primary study outcome was development of infectious complications, especially surgical site infection (SSI), within 30 days of surgery. RESULTS:Between October 2008 and August 2014, 81 patients were enrolled and randomly assigned with a 1:1 allocation ratio (42, LA; 39, OA). All were eligible for study of the primary endpoint. Groups were well balanced in terms of patient characteristics and preoperative levels of C-reactive protein. SSI occurred in 14 LA group patients (33.3 %) and in 10 OA group patients (25.6 %) (OR 1.450, 95 % CI 0.553-3.800; p = 0.476). Overall, the rate of postoperative complications, including incisional or organ/space SSI and stump leakage, did not differ significantly between groups. No significant differences between groups were found in hospital stay, duration of drainage, analgesic use, or parameters for postoperative recovery except days to walking. CONCLUSION: These results suggested that LA for CA is safe and feasible, while the distinguishing benefit of LA was not validated in this clinical trial.
RCT Entities:
BACKGROUND: The aim of this study was to assess whether laparoscopic appendectomy (LA) for complicated appendicitis (CA) effectively reduces the incidence of postoperative complications and improves various measurements of postoperative recovery in adults compared with open appendectomy (OA). METHODS: This single-center, randomized controlled trial was performed in the Nagoya Daini Red Cross Hospital. Patients diagnosed as having CA with peritonitis or abscess formation were eligible to participate and were randomly assigned to an LA group or an OA group. The primary study outcome was development of infectious complications, especially surgical site infection (SSI), within 30 days of surgery. RESULTS: Between October 2008 and August 2014, 81 patients were enrolled and randomly assigned with a 1:1 allocation ratio (42, LA; 39, OA). All were eligible for study of the primary endpoint. Groups were well balanced in terms of patient characteristics and preoperative levels of C-reactive protein. SSI occurred in 14 LA group patients (33.3 %) and in 10 OA group patients (25.6 %) (OR 1.450, 95 % CI 0.553-3.800; p = 0.476). Overall, the rate of postoperative complications, including incisional or organ/space SSI and stump leakage, did not differ significantly between groups. No significant differences between groups were found in hospital stay, duration of drainage, analgesic use, or parameters for postoperative recovery except days to walking. CONCLUSION: These results suggested that LA for CA is safe and feasible, while the distinguishing benefit of LA was not validated in this clinical trial.
Entities:
Keywords:
Complicated appendicitis; Complication; Laparoscopic surgery; Open surgery; RCT
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