Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study.
Tech Coloproctol
; 23(6): 565-571, 2019 Jun.
Article
en En
| MEDLINE
| ID: mdl-31278459
ABSTRACT
BACKGROUND:
Currently, the only clinically valid method to prevent morbidity and mortality related to colorectal anastomotic leaks is by construction of a protective ileostomy. Intraluminal bypass might also be a possible way to proctect the anastomosis. The aim of the present study was to evaluate the CG-100 intraluminal bypass device for the reduction of anastomosis-related morbidity and stoma creation in cases of rectal resection.METHODS:
A prospective study was conducted on patients having sphincter-preserving rectal resection who were treated with the CG-100 device at Soroka University Medical Center, Beer Sheva, Israel between May 2015 and February 2017. The device was implanted during surgery and removed after 10 ± 1 days. All patients underwent a radiologic leak test with water-soluble contrast prior to removal of the device. Patients were followed for 30 days. Information about adverse events, anastomotic leaks, device usability and tolerance were collected.RESULTS:
Forty-seven patients participated in the study. Most patients were operated on due to cancer 44 (93.6%). Four (9%) patients received a primary protective stoma on top of the CG-100 device as part of the learning curve of the surgical team and none required a stoma after device removal. Five (9%) serious adverse events were reported, but only 2 (4%) were classified as related to the device. One was a transient enterocutaneous fistula after removal of the device. The second was an asymptomatic radiologic leak in 1 (2.1%) patient which was treated by keeping the device in place and antibiotic treatment for another 10 days without creation of diverting ileostomy.CONCLUSIONS:
CG-100 may provide a safe method for fecal diversion over a newly created anastomosis without the complications related to stoma creation and closure. A larger prospective randomized study in patients originally scheduled to receive diverting stoma is needed to confirm these findings.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Complicaciones Posoperatorias
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Ileostomía
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Estomas Quirúrgicos
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Fuga Anastomótica
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Proctectomía
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Observational_studies
Límite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Tech Coloproctol
Asunto de la revista:
GASTROENTEROLOGIA
Año:
2019
Tipo del documento:
Article
País de afiliación:
Israel