Evaluation the effect of the gastrojejunostomy technique on the delayed gastric emptying after whipple's surgery
Design
Two arm parallel group with single blinded postoperative care and outcome assessment
Settings and conduct
This clinical trial study will be performed in Arvand Hospital in Ahvaz and in two groups of patients with pancreatic cancer who have been nominated for Vipel surgery. The aim of this study is to investigate the effect of changing the technique of gastrogenogenostomy on gastric emptying after surgery. In the first group, gastrogeogenostomy will be performed with right-to-left anastomosis, and in the second group, left-right gastrogenogenostomy will be performed.
Participants/Inclusion and exclusion criteria
all pancreatic cancer patients who candidate for wipple
Intervention groups
there is 2 group of patient. first standard group and second are patienst who use wipple surgery with differnet technique in gastrojejunostomy anastomosis
Main outcome variables
evaluation of delayed gastric emptying syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190506043492N1
Registration date:2020-04-15, 1399/01/27
Registration timing:registered_while_recruiting
Last update:2020-04-15, 1399/01/27
Update count:0
Registration date
2020-04-15, 1399/01/27
Registrant information
Name
Milad Arabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
arabi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of the gastrojejunostomy technique (right to left or left to right) on the delayed gastric emptying after whipple's surgery
Public title
Evaluation of the effect of gastric surgery technique on gastric emptying
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with pancreatic cancer who are candidates for Vipel surgery
Exclusion criteria:
Patients with pancreatic cancer who have underlying liver disease or gastric gastroparesis.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the patients are aware of the technique of their surgery, but the surgeon and the researcher are aware of the type of technique for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethice committee of ahwaz jondishapour university of Medical sciences
Street address
ahwaz- 30 metri st. Arvand hospital
City
ahwaz
Province
Khouzestan
Postal code
6155635444
Approval date
2019-02-14, 1397/11/25
Ethics committee reference number
IR.AJUMS.REC.1398.110
Health conditions studied
1
Description of health condition studied
Pancreatic cancer
ICD-10 code
C25
ICD-10 code description
Malignant neoplasm: Head of pancreas
Primary outcomes
1
Description
Delyed gastric empty syndrome
Timepoint
from operation day till 3 month after surgery
Method of measurement
history from patient
Secondary outcomes
empty
Intervention groups
1
Description
In the group of interventions in Whipple's surgery, with the right-to-left technique, by rotating one hundred and eighty degrees, the proximal lobe of the genome is connected to the cochlear laser, and after the operation, by phone call, the patient's history, nutrition, severity and The persistence of nausea and vomiting is questioned.
Category
Treatment - Surgery
2
Description
In the control group in Whipple surgery, with the left-to-right technique, the progeny lobe of the genome is connected to the gritter cortex. And after the operation, the patient will be asked by phone call about the patient's history, how to feed, the severity and persistence of nausea and vomiting.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arvand Hospital in Ahwaz
Full name of responsible person
Milad Arabi
Street address
Ahwaz - 30 metri st. Arvand hospital
City
Ahwaz
Province
Khouzestan
Postal code
6155635444
Phone
+98 61 3293 3347
Email
Mimalef83@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Karandish Majid
Street address
Ahwaz Jondishapoor University of Medicine
City
Ahwaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
Mimalef83@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Arabi
Position
Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 43 - Kianpars - 18 th St - Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6155884756
Phone
+98 61 3379 1251
Email
Mimalef83@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amin Bahreini
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golestan Avenue
City
Ahwaz
Province
Khouzestan
Postal code
6133333355
Phone
+98 913 435 2718
Email
am27481@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Arabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
NO43,West18th Ave.Kianpars Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6155884756
Phone
+98 912 237 0272
Email
Mimalef83@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
age - gender - delayed gastric emptynig syndrome - readdmision
When the data will become available and for how long
6 m after sampling
To whom data/document is available
attending of med university - HB surgeons
Under which criteria data/document could be used
for future study in hepatobiliary fileds
From where data/document is obtainable
mimalef83@gmail.com
executor of study
What processes are involved for a request to access data/document