Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
Primary Purpose
Anastomotic Leakage
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Mycostatin oral suspension
Water
Sponsored by
About this trial
This is an interventional treatment trial for Anastomotic Leakage focused on measuring esophageal cancer, anastomotic leakage, Prevention of anastomotic leakage after esophageal surgery
Eligibility 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.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Sham Comparator
Experimental
Arm Label
1
2
3
Arm Description
no intervention with perioperative oral anti-infective agent or water for gargling
perioperative gargling with water
perioperative oral gargling with oral anti-infective agent for seven days
Outcomes
Primary Outcome Measures
all cause anastomotic leakage
Secondary Outcome Measures
Time variation of starting oral feeding and hospital stay
Full Information
NCT ID
NCT00942526
First Posted
July 20, 2009
Last Updated
July 20, 2009
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00942526
Brief Title
Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
Official Title
The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leakage
Keywords
esophageal cancer, anastomotic leakage, Prevention of anastomotic leakage after esophageal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
no intervention with perioperative oral anti-infective agent or water for gargling
Arm Title
2
Arm Type
Sham Comparator
Arm Description
perioperative gargling with water
Arm Title
3
Arm Type
Experimental
Arm Description
perioperative oral gargling with oral anti-infective agent for seven days
Intervention Type
Drug
Intervention Name(s)
Mycostatin oral suspension
Intervention Description
peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
perioperative gargling with water
Primary Outcome Measure Information:
Title
all cause anastomotic leakage
Time Frame
two years
Secondary Outcome Measure Information:
Title
Time variation of starting oral feeding and hospital stay
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Ming Huang, MD
Phone
+886-2-23123456
Ext
63509
Email
e370089@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Ming Huang, MD
Organizational Affiliation
Department of Surgery, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Ming Huang, MD
Phone
+886-2-23123456
Ext
63509
Email
e370089@gmail.com
First Name & Middle Initial & Last Name & Degree
Pei-Ming Huang, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
6865459
Citation
Liu K, Zhang GC, Cai ZJ. Avoiding anastomotic leakage following esophagogastrostomy. J Thorac Cardiovasc Surg. 1983 Jul;86(1):142-5.
Results Reference
background
PubMed Identifier
11133560
Citation
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. doi: 10.2214/ajr.176.1.1760161.
Results Reference
background
PubMed Identifier
8091778
Citation
Bardini R, Asolati M, Ruol A, Bonavina L, Baseggio S, Peracchia A. Anastomosis. World J Surg. 1994 May-Jun;18(3):373-8. doi: 10.1007/BF00316817.
Results Reference
background
PubMed Identifier
3280882
Citation
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.
Results Reference
background
PubMed Identifier
1575303
Citation
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. doi: 10.1016/0002-9610(92)90393-6.
Results Reference
background
PubMed Identifier
1548890
Citation
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. doi: 10.1002/jso.2930490307.
Results Reference
background
Links:
URL
http://www.ntuh.gov.tw/RECO
Description
National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)
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Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
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