Trial reportSurgical endoscopy2025
RCT comparing the clinical efficacy and costs of two tissue approximation devices in the closure of large post-endoscopic resection defects.
Trial report in Surgical endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05163665 (Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects), which is not on this map. Cited by 1 paper.
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.
Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
Who cites it
1 citing paper in PubMed.
- Dual Action Tissue Clip: A New Kid on the Block for Large Defect Closure - Report of Two Cases.GE Portuguese journal of gastroenterologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionClosure techniques for large endoscopic resection defects (ERD) have shifted from one step tissue apposition to tissue approximation first followed by complete closure. We compared the clinical efficacy and cost of two novel through-the-scope (TTS) tissue approximation devices in the management of large ERD.
methodsSingle-center, prospective, randomized trial of ERD greater than 20 mm (width) or 30 mm (length). Approximation was performed via the dual-action tissue clip (DAT) or the TTS tack/suture device (TSD). The primary outcome was tissue approximation cost. The additional cost per successful tissue approximation (Incremental Cost-Effective Ratio) was calculated to determine cost-effectiveness.
resultsThe mean resection bed length (41.1 mm vs 40.7, p = 0.89) and width (23.8 mm vs 25.3 mm, p = 0.37) were similar in the TSD (n = 42) and DAT (n = 41) groups, respectively. Cost of tissue approximation ($946.60 vs $680.00, p = 0.001, 95% CI 120.8, 414.88, effect size d = 0.83) and complete closure ($2.10/mm2 vs $1.62/mm2, p = 0.04,95% CI 96.0, 601.3, d = 0.51) was higher in the TSD group. Technical success in tissue approximation (85.7% vs 90.2%, p = 0.56) and complete closure (97.6% vs 95.1%, p = 0.55) were similar in both TSD and DAT groups. However, TSD appeared to be more effective within the duodenum and when the resection bed was > 50% of the circumference. The ICER was-$6650.00 favoring the DAT clip. Approximation time (12.4 min vs. 4.2, p < 0.001, 95% CI 5.9, 10.6, d = 1.66) and closure speed (50.4 mm2/min vs 105.1 mm2/min, p < 0.001, 95% CI 30.9, 78.4, d = 1.08) were faster in the DAT arm. One clinically significant bleeding occurred in one subject in both groups.
conclusionIn this RCT, both TTS approximation devices equally facilitated approximation/closure of large ERD. Approximation with the DAT clip was faster and overall more cost-effective, but further studies are needed to determine the most appropriate approximation device based on location. The trial was registered in ClinicalTrials.gov under this identifier: NCT05163665.
Indexed as
Identifiers
40640617What 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.