Trial reportLangenbeck's archives of surgery2024
Ghost-ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer: results of a randomised controlled multicentre pilot trial (DRKS00013997).
Trial report in Langenbeck's archives of surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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.
methodsThis 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.
resultsRecruiting 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.
conclusionGhost 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.
Indexed as
Identifiers
39520543What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.