Randomised Controlled Pilot Trial on GHOST Ileostomy versus Conventional Loop Ileostomy in Patients Undergoing low Anterior Resection for Rectal Cancer

Abstract

Abstract Background Anastomotic leakage is the most important complication after colorectal surgery. In patients undergoing low anterior resection with total mesorectal excision (LAR/TME) a loop ileostomy is fashioned to protect the low anastomosis. Ghost ileostomy is a pre-stage ileostomy, which can be converted to a diverting ileostomy, if anastomotic leakage is suspected. If there are no signs of anastomotic leakage an actual ileostomy can be avoided. Aims The objective was to evaluate whether ghost ileostomy is a safe alternative to a conventional loop ileostomy. Methods GHOST was a randomised controlled pilot trial without formal hypothesis. Patients undergoing LAR/TME for rectal cancer were intraoperatively randomised to receive a ghost ileostomy or loop ileostomy. Patients were followed prospectively for 6 months. Comprehensive complication index, transformation of ghost ileostomy into loop ileostomy, presence of an ostomy at 6 months, Wexner score and quality of life were assessed. Results Thirty patients were equally randomised. The CCI was 30.7 (± 17.7) in the ghost ileostomy group compared to 29.7 (± 18.6) in the loop ileostomy group at 6 months (p=0.889). The ghost ileostomy was converted into a loop ileostomy in 6 of 15 (40.0%) patients. At 6 months after low anterior resection, 6 (40.0%) patients in the ghost ileostomy group and 7 (46.7%) patients in the ileostomy group still had an ileostomy. There was no mortality and no need for creation of a terminal ostomy within the trial. Neither postoperative function assessed by the Wexner score, nor the overall quality of life showed significant differences. Conclusion Ghost ileostomy seems to be a viable and safe option to a more selective approach regarding creation of an ileostomy in patients undergoing LAR/TME. However, the difficult patient selection with exclusion of patients at high risk of anastomotic leakage limits its widespread application and should be optimised in future trials.