Protocol summary

Summary
All of the patients with resectable esophageal cancer admitted to thoracic surgical ward for esophagectomy for 12 month are included in this study. The patients are randomly divided in two groups. 30 patients of controlled group (group 1) are not performed pyloromyotomy during transhiatal esophagectomy. 30 patients of interventional group (group 2) are performed pyloromyotomy during transhiatal esophagectomy. In this study other variables such as age, gender, location of tumor, histopathology, complications and perioperative discomforts are also will be studied. All patients of two groups will be studied with radioisotope scanning for determination of gastric emptying and will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104153831N2
Registration date: 2011-05-14, 1390/02/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-05-14, 1390/02/24
Registrant information
Name
Mohsen Sokouti
Name of organization / entity
Department of Thoracic Surgery
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 6634
Email address
sokoutim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2012-01-01, 1390/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pyloromyotomy in gastric drainage in the gastric pull up for esophageal cancer resection
Public title
The effect of pyloromyotomy in gastric drainage after esophagectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All of the patients with resectable esophageal carcinoma admitted to Imam Reza Hospital. Exclusion criteria: 1- Nonoperable esophageal carcinoma, 2- Diabetes, 3- Severe cardiopulmonary compromises, 4- Patients who did not performed gastric emptying isotope scan after surgery, 5- Patients who died perioperatively until two months after surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Daneshgah Avenue
City
Tabriz
Postal code
5166614756
Approval date
2011-04-25, 1390/02/05
Ethics committee reference number
903

Health conditions studied

1

Description of health condition studied
Esophageal cancer
ICD-10 code
C15.3, C15
ICD-10 code description
Malignant neoplasm of oesophagus

Primary outcomes

1

Description
Gastric emptying after esophagectomy
Timepoint
Two months after surgery
Method of measurement
Gastric emptying radioisotope scan

Secondary outcomes

1

Description
Cough
Timepoint
after eating - between meals
Method of measurement
Patient complain

2

Description
fullness
Timepoint
after eating
Method of measurement
Patient complain-Gastric emptying radioisotope scan

3

Description
Regurgitation
Timepoint
after eating - between meals
Method of measurement
Patient complain

Intervention groups

1

Description
Control group: esophagectomy without Pyloromyotomy.
Category
N/A

2

Description
Intervention group: esophagectomy with Pyloromyotomy.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Doctor Mohsen Sokouti
Street address
Golgasht Avenue
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences and health service
Full name of responsible person
Dr Mohammad Reza Rashidi - Vice chancellory for research
Street address
Daneshgah Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences and health service
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health services
Full name of responsible person
Dr Mohsen Sokouti
Position
Subspecialist in Thoracic Surgery - Associate professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences and Health services, Golgasht Avenue
City
Tabriz
Postal code
5166614756
Phone
+98 411335731011
Fax
+98 41 1334 4280
Email
Sokouti.mohsen@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr Mohsen Sokouti
Position
Associate professor of Thoracic Surgery
Other areas of specialty/work
Street address
Golgasht Avenue, Tabriz University of Medical Sciences And Health Services
City
Tabriz
Postal code
5166614756
Phone
+98 411335731011
Fax
+98 41 1334 4280
Email
Sokouti.mohsen@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr Mohsen Sokouti
Position
Associate professor of Thoracic Surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences and Health Services, Golgasht Avenue
City
Tabriz
Postal code
5166614756
Phone
+98 411335731011
Fax
+98 41 1334 4280
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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