A Phase 2 interventional study of Mycostatin oral suspension and Water in Anastomotic Leakage, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-07-21.
Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Treatment
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.
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:
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.
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.
209 studies on the registry are indexed under Anastomotic Leak; 60 are open to participants now.
This study's planned enrollment of 120 is close to the median of 121 across 100 interventional studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
no intervention with perioperative oral anti-infective agent or water for gargling
perioperative gargling with water
Other: Water
perioperative oral gargling with oral anti-infective agent for seven days
Drug: Mycostatin oral suspension
peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days
perioperative gargling with water
all cause anastomotic leakage
Time frame: two years
Time variation of starting oral feeding and hospital stay
Time frame: two years
This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital