Ghost-ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer: results of a randomised controlled multicentre pilot trial (DRKS00013997).

Purpose: The objective of the current pilot trial was to evaluate whether ghost ileostomy is a safe alternative to the current standard of care in terms of a conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision (LAR/TME) for rectal cancer.

Methods: This randomized controlled pilot trial included patients undergoing LAR/TME, randomly assigning them to ghost ileostomy or conventional loop ileostomy intraoperatively. Follow-up spanned 6 months, evaluating the following endpoints: comprehensive complication index (CCI), postoperative morbidity, transformation of ghost ileostomy, presence of ostomy at 6 months, Wexner score, and quality of life (EORTC QLQ-C30 & CR29). Exploratory statistical analysis based on the intention-to-treat principle was conducted.

Results: Recruiting 30 patients from May 2018 to September 2022, the trial was prematurely stopped due to slow recruitment. The mean CCI was comparable between groups at any point of time (at 6 months: 30.7 vs. 29.7, p = 0.889). There was no mortality and no need for creation of a terminal ostomy. Anastomotic leakage rates were similar in ghost ileostomy and loop ileostomy groups (p > 0.99). The ghost ileostomy was converted into a conventional loop ileostomy in 6 of 15 (40.0%) patients. Neither postoperative function, nor the overall quality of life showed significant differences.

Conclusion: Ghost ileostomy appears as a viable and safe option for selectively deciding ileostomy creation in LAR/TME for rectal cancer. However, challenges in patient selection, excluding those at high risk for anastomotic leakage, limit widespread application and call for optimization in future research.

Trial-registration: German Clinical Trials Register ( https://drks.de/ ): DRKS00013997; date of registration: April 9th 2018.