Mechanical bowel preparation with or without oral antibiotics for rectal resection for cancer (REPCA trial): a study protocol for a multicenter randomized controlled trial.

BACKGROUND: There is still a lack of randomized trials assessing the clinical value of mechanical bowel preparation (MBP) and oral antibiotics (OA) before rectal surgery. Existing studies are inconsistent regarding OA. The aim of this study is to examine the role of MBP with or without OA (using Alfa Normix®) on postoperative complications in patients undergoing rectal resection for cancer. METHODS: We are conducting a prospective multicenter randomized controlled trial comparing MBP (Moviprep®) with OA (Alfa Normix®) versus MBP alone in patients undergoing elective rectal resection for cancer. Patients with rectal or rectosigmoid cancer are randomized in a 1:1 allocation ratio. The primary endpoint is incisional surgical site infection (SSI) assessed within 30 days after surgery. Secondary endpoints are anastomotic leakage (AL), organ/space SSI, other postoperative complications, intraoperative complications, operation time, bowel preparation quality, bowel preparation adherence. Intention-to-treat and per protocol analyses will be performed. CONCLUSIONS: The results of the REPCA trial will demonstrate whether MBP + OA is superior to MBP alone in rectal cancer surgery. This trial might influence current preoperative practice and improve postoperative outcomes.

Technical success and short-term results of surgical treatment of gastrointestinal stromal tumors: an experience of three centers.

BACKGROUND: Gastrointestinal stromal tumors (GIST) comprise about 80% of gastrointestinal sarcomas. In patients with localized disease, surgery is considered as "Gold Standard" treatment. Organ-sparing radical en-block resection is widely accepted practice. Since lymph node dissection is not routinely indicated, minimally invasive approach is of particular interest. The aim of this study is to investigate the short-term outcomes of different surgical treatment of GISTs. METHODS: We analyzed data of 116 patients who received surgical treatment for localized forms of GIST. Tumors were located in the stomach in 87 (75%) cases, in the small intestine in 26 (22.4%) cases, and extragastrointestinal GISTs were found in 3 (2.6%) patients. Four different approaches were used-open surgery (OpS, n=48), laparoscopic surgery (LS, n=40), endoscopic procedures (EP, n=22) and hybrid rendezvous (HR, n=6). Patient demographics, clinical presentation of tumors, characteristics of operation procedures (duration, intraoperative blood loss, frequency of R0-resection and fragmentation of tumor), postoperative complications and length of hospital stay were examined in all these groups. RESULTS: Radical treatment (R0-resection) was performed in all patients. There were no cases of tumor ruptures during surgical procedure. Mean size of GIST in OpS was 9.1±2.0 [2-35] cm; in LS: 4.9±0.8 (1.5-15) cm; in HR: 3.5±0.8 (2-4.5) cm and in EP: 2.3±0.3 (0.4-3.5) cm. Intraoperative blood loss in OpS was 369.7±209.5 [0-4,000] mL; LS: 63.9±16.0 [0-150] mL; in HR: 96.7±44.3 [50-200] mL; in EP: 33.3±11.0 [0-150] mL. Duration of operation in OpS was 160±20.4 [50-310] min; in LS: 104.7±12.7 [50-185]; in HR: 176.7±44.0 [110-260] min and in EP: 89.8±15.5 [25-190] min. Complication rate in OpS was 5 (10.4%); in LS: 3 (7.5%); in HR: 0% and in EP: 3 (13.6%). Length of hospital stay in OpS was 13.8±2.2 [7-52] days; in LS: 11, 4±2.2 [4-21] days; in HR: 11±3.2 [7-15] days and in EP: 11, 9±2.1 [5-22] days. There were no postoperative deaths. CONCLUSIONS: There is a diversity of surgical approaches for GISTs treatment. From our point of view, the main selection criteria for certain procedure are size, localization, growth type of the tumor and status of overlying mucosa. Nevertheless, due to relative rarity and heterogeneity of this pathology, individualization is necessary in each specific case. Laparoscopic and endoscopic surgery is proved to be safe and feasible for resection of the gastric GISTs, with a reasonable operation time, low blood loss, and an acceptable complication rate. Immediate results indicate that all interventions were performed radically without mortality or serious morbidity.