Endoluminal Vacuum Therapy Using a New “Fistula Sponge” in Treating Defects of the Upper Gastrointestinal Tract—A Comparative, Retrospective Cohort Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Inclusion Criteria
- Transmural wall defect of the uGIT.
- Independent indication for endoscopic vacuum therapy after interdisciplinary case discussion.
- Valid declaration of consent from the UKSH for scientific data collection (“broad consent” UKSH), in the electronic patient file.
2.3. Exclusion Criteria
- Deviation from the standard procedure of EVT.
2.4. Endpoints
- The primary endpoint was defined as the clinical success, namely the complete resolution of the transmural defect lined with granulation tissue.
- Secondary endpoints were: patient characteristics, duration of EVT, number of changes of respective EVT-system, the initial size of transmural defect, complications, and rate of morbidity and mortality during follow-up.
2.5. Conventional Endoluminal Vacuum Therapy (cEVT)
2.6. Fistula Sponge (FS) Therapy
2.7. Data Collection and Follow-Up
2.8. Bench Study to Compare Throughput of EVT Systems
2.9. Statistical Analysis Methods
3. Results
3.1. Patient Characteristics
3.2. Primary EndpointRate of Defect Healing
3.3. Secondary Endpoint
3.3.1. Defect Size
3.3.2. Duration of Therapy and Number of Sponge Changes
3.3.3. Time Interval until the Start of the EVT
3.3.4. Complication Rate and Therapy
3.3.5. Follow-Up, 30-Day Mortality
3.3.6. Bench Testing of Suction Capacity
4. Discussion
Comparative Measurements of Suction Power
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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cEVT | FS-EVT | p-Value | |
---|---|---|---|
Number of patients [N] | 47 | 24 | |
Age [years] | 62.8 ± 15.7 | 65.0 ± 16.3 | 0.42 |
Female [N] (%) | 11 (23.4) | 2 (8.3) | 0.19 |
Indication [N] (%) | |||
Anastomotic insufficiency | 21 (44.7) | 8 (33.3) | 0.67 |
Perforation | 26 (55.3) | 16 (66.7) | 0.64 |
Location of defect from dental arch [N] (%) | |||
15–23 cm | 3 (6.4) | 2 (8.3) | 0.84 |
24–32 cm | 30 (63.8) | 14 (58.3) | 0.78 |
33–40 cm | 10 (21.3) | 7 (29.2) | 0.73 |
>40 cm | 4 (8.5) | 1 (4.2) | 0.52 |
Body mass index [kg/m2] (mean ± SD 1) | 27.6 ± 8.9 | 26.0 ± 6.4 | 0.58 |
ASA 2 Score | 3 (2–4) | 2 (1–4) | 0.87 |
Malignancy [N] (%) | 31 (65.9) | 18 (75) | 0.59 |
Neoadjuvant treatment [N] (%) | 18 (38.3) | 9 (37.5) | 0.99 |
Interval between surgery and EVT [d] (mean ± SD) | 5.8 ± 5.7 | 6.2 ± 5.5 | 0.84 |
EVT-Associated Complications | cEVT 1 (N = 47) | FS-EVT 2 (N = 24) | p-Value |
---|---|---|---|
Bleeding [N] (%) | 1 (2.1) | 0 (0) | >0.99 |
Ingrowth/Tearing off of the sponge [N] (%) | 0 (0) | 0 (0) | >0.99 |
Technically not possible [N] (%) | 0 (0) | 2 (8.3) | 0.11 |
Stenosis [N] (%) | 8 (17) | 3 (12.5) | 0.74 |
Fistula recurrence or persistent fistula [N] (%) | 4 (8.5) | 0 (0) | 0.29 |
Total complication rate [N] (%) | 13 (27.7) | 5 (20.8) | 0.58 |
cEVT 1 (N = 47) | FS-EVT 2 (N = 24) | p-Value | |
---|---|---|---|
Treatment-associated 30-day mortality [N] (%) | 2 (4.3) | 1 (4.0) | >0.99 |
30-day mortality total [N] (%) | 10 (21.3) | 5 (20.8) | 0.08 |
6-month mortality total [N] (%) | 1 (2.1) | 2 (8.3) | 0.26 |
Completed 12-month follow-up | 36 (76.6) | 17 (70.8) | 0.77 |
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Richter, F.; Conrad, C.; Hoffmann, J.; Reichert, B.; von Schoenfels, W.; Schafmayer, C.; Egberts, J.-H.; Becker, T.; Ellrichmann, M. Endoluminal Vacuum Therapy Using a New “Fistula Sponge” in Treating Defects of the Upper Gastrointestinal Tract—A Comparative, Retrospective Cohort Study. Medicina 2024, 60, 1105. https://doi.org/10.3390/medicina60071105
Richter F, Conrad C, Hoffmann J, Reichert B, von Schoenfels W, Schafmayer C, Egberts J-H, Becker T, Ellrichmann M. Endoluminal Vacuum Therapy Using a New “Fistula Sponge” in Treating Defects of the Upper Gastrointestinal Tract—A Comparative, Retrospective Cohort Study. Medicina. 2024; 60(7):1105. https://doi.org/10.3390/medicina60071105
Chicago/Turabian StyleRichter, Florian, Claudio Conrad, Julia Hoffmann, Benedikt Reichert, Witigo von Schoenfels, Clemens Schafmayer, Jan-Hendrik Egberts, Thomas Becker, and Mark Ellrichmann. 2024. "Endoluminal Vacuum Therapy Using a New “Fistula Sponge” in Treating Defects of the Upper Gastrointestinal Tract—A Comparative, Retrospective Cohort Study" Medicina 60, no. 7: 1105. https://doi.org/10.3390/medicina60071105