Protocol summary
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Study aim
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Determining and comparing the outcome of pyloric drainage in the form of pyloromyotomy and mikulicz pyloromyoplasty with not performing it in patients with lower esophageal cancer undergoing trans-hiatal esophagectomy and reconstruction by orringer method in Isfahan educational-medical centers
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Design
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Uncontrolled, parallel-group, double-blind, randomized, phase 2 clinical trial on 45 patients. Computer randomized numbering method was used for randomization.
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Settings and conduct
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The present study is a double-blind interventional study, so that the patient and the person who collects the data are not aware of the type of drainage performed, and the type of operation is delivered to the surgeon in a sealed envelope). The studied population is patients with distal esophageal cancer, which makes them candidates for esophagectomy, who are operated on in Isfahan educational-medical centers
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Participants/Inclusion and exclusion criteria
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The criteria for entering patients is to undergo total esophagectomy in Isfahan educational centers. The criteria for patients to be excluded from our study will be perioperative mortality due to medical or surgical complications or gastric ischemia or necrosis.
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Intervention groups
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Three groups: "Esophagectomy alone", "Esophagectomy + pyloromyotomy" and "Esophagectomy + mikulicz pyloroplasty"
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Main outcome variables
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Length of hospitalization; Length of stay in ICU; Need for re-intervention; Occurrence of clinical symptoms of delayed gastric emptying; Occurrence of radiological signs of delayed gastric emptying; Occurrence of aspiration during hospitalization; Observation of radiological signs of leakage from anastomosis in barium swallow test
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221117056530N1
Registration date:
2023-02-06, 1401/11/17
Registration timing:
prospective
Last update:
2024-03-06, 1402/12/16
Update count:
1
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Registration date
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2023-02-06, 1401/11/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-20, 1401/12/01
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Expected recruitment end date
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2023-06-21, 1402/03/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the outcome of pyloric drainage in pyloromyotomy and mikulicz pyloroplasty with not performing it in patients with lower esophageal cancer undergoing orringer surgery
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Public title
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Comparison of the outcome of pyloric drainage in pyloromyotomy and mikulicz pyloroplasty with not performing it in patients with lower esophageal cancer undergoing orringer surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Undergoing total esophagectomy surgery
Exclusion criteria:
History of previous laparotomy
Deudenal ulcer in preoperative endoscopy
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly divided into three groups, "esophagectomy alone", "esophagectomy + pyloromyotomy" and "esophagectomy + mikulicz pyloroplasty" using the computer random number method, and the sealed envelope will be presented to the surgeon in the operating room. This randomization of patients will be done by an independent computer programmer using the www.randomization.com database.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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After randomizing the patients into two groups, an independent researcher will write the type of operation in a sealed envelope. The patient and the person who collects the data are not aware of the type of drainage, and the sealed envelope is presented to the surgeon in the operating room.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-06-22, 1401/04/01
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Ethics committee reference number
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IR.MUI.MED.REC.1401.130
Health conditions studied
1
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Description of health condition studied
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Esophageal cancer
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ICD-10 code
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C15.9
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ICD-10 code description
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Malignant neoplasm of esophagus, unspecified
Primary outcomes
1
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Description
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Occurrence of clinical symptoms of delayed gastric emptying
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Timepoint
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3 months after the operation
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Method of measurement
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History taking
Intervention groups
1
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Description
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Intervention group: Esophagectomy alone which is the gold standard treatment of esophageal cancer.
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Category
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Treatment - Surgery
2
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Description
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Intervention group: Esophagectomy + pyloromyotomy in which the surgeon creates an incision in the pyloric wall in addition to esophagectomy.
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Category
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Treatment - Surgery
3
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Description
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Intervention group: Esophagectomy + mikulicz pyloroplasty in which a horizontal incision is made across the pylorus and then is closed vertically, to widen the pyloric orifice.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Information is kept confidential.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Information about the main outcome can be shared.
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When the data will become available and for how long
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After publishing the results
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Using data to complete studies
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From where data/document is obtainable
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Dr. Samira Heidari Katayouncheh, Isfahan University of Medical Sciences
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What processes are involved for a request to access data/document
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By examining the researcher's request and providing sufficient documentation of his research and the reason for using the data can be provided.
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Comments
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