Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
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|ClinicalTrials.gov Identifier: NCT00942526|
Recruitment Status : Unknown
Verified July 2009 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : July 21, 2009
Last Update Posted : July 21, 2009
|Condition or disease||Intervention/treatment||Phase|
|Anastomotic Leakage||Drug: Mycostatin oral suspension Other: Water||Phase 2|
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.
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
No Intervention: 1
no intervention with perioperative oral anti-infective agent or water for gargling
Sham Comparator: 2
perioperative gargling with water
perioperative gargling with 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
- all cause anastomotic leakage [ Time Frame: two years ]
- Time variation of starting oral feeding and hospital stay [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942526
|Contact: Pei-Ming Huang, MD||+886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Pei-Ming Huang, MD +886-2-23123456 ext 63509 email@example.com|
|Principal Investigator: Pei-Ming Huang, MD|
|Principal Investigator:||Pei-Ming Huang, MD||Department of Surgery, National Taiwan University Hospital|