Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial.

摘要: Introduction Anastomotic leakage is the most important complication in colorectal surgery occurring up to 20% after low anterior rectal resection. Therefore, a diverting ileostomy usually created during resection protect anastomosis or rather diminish consequences case of anastomotic leakage. The so-called virtual ghost pre-stage ostomy that can be easily exteriorised, if suspected, order avoid severe On other hand, an actual avoided patients, who do not develop Methods and analysis GHOST trial randomised controlled pilot comparing with conventional loop patients undergoing total mesorectal excision for cancer. After screening eligibility obtaining informed consent, 60 adult are included trial. Patients intraoperatively groups 1:1 ratio assuring none intraoperative exclusion criteria present. main outcome parameter comprehensive index as measure safety. Further outcomes include specific complications, stoma-related complications closure, frequency transformation into ileostomy, terminal creation, proportion at 6 months surgery, anorectal function (Wexner score) quality life assessed by European Organisation Research Treatment Cancer (EORTC) QLQ-C30 CR29 questionnaires. Follow-up each individual patient will months. Ethics dissemination has been approved Medical Committee Heidelberg University (reference number S-694/2017). If intervention proves safe, could spared large thus also avoiding second operation (ileostomy closure) its inherent these patients. Trial registration German Clinical Trials Registry (DRKS00013997); Universal Number: U1111-1208-9742.