Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anastomotic Leakage
Intervention: Mycostatin oral suspension (Drug); Water (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s): Pei-Ming Huang, MD, Principal Investigator, Affiliation: Department of Surgery, National Taiwan University Hospital
Overall contact: Pei-Ming Huang, MD, Phone: +886-2-23123456, Ext: 63509, Email: e370089@gmail.com
Summary
Anastomotic leakage is still to be a major cause of considerable morbidity and mortality
after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of
anastomotic leakage, including blood supply, graft tension, and comorbidity, have been
performed, but few studies have produced strategies that have improved operative results.
This study will be performed to identify prognostic variables that might be used to develop
a strategy for optimizing outcomes after esophagogastrectomy.
Clinical Details
Official title: The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: all cause anastomotic leakage
Secondary outcome: Time variation of starting oral feeding and hospital stay
Detailed description:
Goal:
The effect of oral hygiene on the occurrence of esophagogastric anastomotic leakage has not
yet been studied for along time. We will use a random cohort study model and investigate the
effect of perioperative oral anti-infective gargle agent on the esophagogastric anastomotic
wound healing.
Method:
1. Design:
One hundred and twenty patients are divided into 3 groups and each group has 40
esophageal patients. Minimization stratified randomization will be applied. Oral
anti-infective gargling agent, Mycostatin oral suspension, will be employed for one
week before operation. The first groups will be treated without oral gargle agent; the
second groups will be treated with gargling water; and the third groups will be treated
with anti-infective gargling agent.
An end-to-side two-layer esophagogastric anastomosis will be constructed using
interrupted sutures with metallic staple through cervical wound. On the other hand, the
anastomotic leakage rates in different groups will be investigated.
2. Data Collection and Statistic Analysis:
The records of all patients, various biologic parameters, and the management of leakage are
analyzed. Thirty-day morbidity and mortality are determined, and stepwise multivariable
logistic regression analysis assesses the effect of preoperative and postoperative variables
on anastomotic leakage. Time variation of starting oral feeding and hospital stay are
compared using the Kaplan-Meier method.
Eligibility
Minimum age: 40 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- carcinoma of the esophagus, operable stage I to III
Exclusion Criteria:
- patients who were inoperable,
- patients who had obvious impaired blood supply of gastric substitutes, and
- patients who had non-cervical esophagogastrostomy.
Locations and Contacts
Pei-Ming Huang, MD, Phone: +886-2-23123456, Ext: 63509, Email: e370089@gmail.com
National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting Pei-Ming Huang, MD, Phone: +886-2-23123456, Ext: 63509, Email: e370089@gmail.com Pei-Ming Huang, MD, Principal Investigator
Additional Information
National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)
Related publications: Liu K, Zhang GC, Cai ZJ. Avoiding anastomotic leakage following esophagogastrostomy. J Thorac Cardiovasc Surg. 1983 Jul;86(1):142-5. Roy-Choudhury SH, Nicholson AA, Wedgwood KR, Mannion RA, Sedman PC, Royston CM, Breen DJ. Symptomatic malignant gastroesophageal anastomotic leak: management with covered metallic esophageal stents. AJR Am J Roentgenol. 2001 Jan;176(1):161-5. Bardini R, Asolati M, Ruol A, Bonavina L, Baseggio S, Peracchia A. Anastomosis. World J Surg. 1994 May-Jun;18(3):373-8. Review. Peracchia A, Bardini R, Ruol A, Asolati M, Scibetta D. Esophagovisceral anastomotic leak. A prospective statistical study of predisposing factors. J Thorac Cardiovasc Surg. 1988 Apr;95(4):685-91. Dewar L, Gelfand G, Finley RJ, Evans K, Inculet R, Nelems B. Factors affecting cervical anastomotic leak and stricture formation following esophagogastrectomy and gastric tube interposition. Am J Surg. 1992 May;163(5):484-9. Patil PK, Patel SG, Mistry RC, Deshpande RK, Desai PB. Cancer of the esophagus: esophagogastric anastomotic leak--a retrospective study of predisposing factors. J Surg Oncol. 1992 Mar;49(3):163-7.
Starting date: June 2009
Last updated: July 20, 2009
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