The aim of this study was to compare gastrointestinal function & complication after gastrectomy in Billroth2 with Braun anastomosis & Roux en Y gastrojejeunostomy reconstructions.
Design
Two arm parallel group randomized clinical trial with 80 patients in two groups. Randomization method is randomized block randomization .
Settings and conduct
The study is conducted in Be'sat hospital & Taleghani hospital in Tehran.
This is single blinded trial and the patients have no information about gastric reconstruction technique.
Participants/Inclusion and exclusion criteria
Patients diagnosed with gastric cancer or gastric ulcer who are candidate for partial gastrectomy. Exclusion criteria: ASA score more than 3, pregnancy, synchronous other malignancy and uncontrolled disease.
Intervention groups
Gastrectomy patients assigned to two groups, first with Billroth 2 with Braun anastomosis as gastric reconstruction technique and the other with Roux en Y gastrojejenustomy.
Main outcome variables
In patients follow up, we assess reflux, dumping syndrome, obstruction and delayed emptying and addmission. If the patients have any symptoms, endoscopic evaluation will be done for gastritis, esophagitis, and anastomosis site stenosis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130706013875N3
Registration date:2020-05-05, 1399/02/16
Registration timing:registered_while_recruiting
Last update:2020-05-05, 1399/02/16
Update count:0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Farhad Fathi
Name of organization / entity
Shahid Beheshti University of Medical Sciencces
Country
Iran (Islamic Republic of)
Phone
+98 21 4427 7264
Email address
ffathi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-30, 1398/05/08
Expected recruitment end date
2020-07-29, 1399/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Roux en Y gastrojejunostomy and Billroth II with Braun anastomosis in partial gastrectomy patients
Public title
Comparison between Roux en Y gastrojejunostomy and Billroth II with Braun anastomosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with gastric cancer or gastric ulcer who are candidate for partial gastrectomy
Exclusion criteria:
Patients who are or become pregnant
Patients with uncontrolled disease
Patients with synchronous other malignancy
Patients with American Society Anesthesiology Score more than 3
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Individuals are randomly divided into two groups based on randomized block randomization method. Randomized blocks are used for this purpose. A random sample based on this method from Sealedenvelope.com has been extracted.
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
AJA University of Medical Sciences
Street address
AJA universitu of Medical Sciences, ,Etemadzadeh st,West Fatemi Ave.Amirabad town
City
Tehran
Province
Tehran
Postal code
IR.AJAUMS.REC.1398.0
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.AJAUMS.REC.1398.092
Health conditions studied
1
Description of health condition studied
gastric cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
2
Description of health condition studied
Gastric ulcer
ICD-10 code
K25
ICD-10 code description
Gastric ulcer
Primary outcomes
1
Description
Gastroesophageal Reflux
Timepoint
3 months after surgery
Method of measurement
GerdQ questionnaire
2
Description
Dumping syndrome
Timepoint
3 months after surgery
Method of measurement
Medical history taking and examination
3
Description
obstruction and delayed emptying
Timepoint
3 months after surgery
Method of measurement
Medical history taking and examination
4
Description
Gastritis
Timepoint
3 months after surgery
Method of measurement
Endoscopy
5
Description
esophagitis
Timepoint
3 months after surgery
Method of measurement
Endoscopy
6
Description
Anastomosis site stenosis
Timepoint
3 months after surgery
Method of measurement
Endoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Billroth II with Braun anastomosis group: After gastrectomy, reconstruction will be performed with Billroth 2 and Braun anastomosis.
Category
Treatment - Surgery
2
Description
Roux en Y gastrojejunostomy group: After gastrectomy, reconstruction will be performed with Roux en Y gastrojejunostomy procedure.