Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anastomotic Leakage |
Drug: Mycostatin oral suspension Other: Water |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer |
- all cause anastomotic leakage [ Time Frame: two years ] [ Designated as safety issue: No ]
- Time variation of starting oral feeding and hospital stay [ Time Frame: two years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
no intervention with perioperative oral anti-infective agent or water for gargling
|
|
|
Sham Comparator: 2
perioperative gargling with water
|
Other: Water
perioperative gargling with water
|
|
Experimental: 3
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
|
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:
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.
- 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| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Pei-Ming Huang, MD | +886-2-23123456 ext 63509 | e370089@gmail.com |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Pei-Ming Huang, MD +886-2-23123456 ext 63509 e370089@gmail.com | |
| Principal Investigator: Pei-Ming Huang, MD | |
| Principal Investigator: | Pei-Ming Huang, MD | Department of Surgery, National Taiwan University Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Pei-Ming Huang, Department of Surgery, National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00942526 History of Changes |
| Other Study ID Numbers: | 200806035R |
| Study First Received: | July 20, 2009 |
| Last Updated: | July 20, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
esophageal cancer anastomotic leakage Prevention of anastomotic leakage after esophageal surgery |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Anastomotic Leak Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Postoperative Complications |
Pathologic Processes Anti-Infective Agents Nystatin Therapeutic Uses Pharmacologic Actions Antifungal Agents Ionophores Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013