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comparative study of the mean urinary level of oxalate after Roux-n-Y gastric bypass, omega loop gastric bypass and sleeve gastrectomy in patients referred to Alzahra and Kashani hospital

Protocol summary

Study aim
1- Determination and comparison of the average level of urinary oxalate according to kind of surgery 2- Determination and comparison of the average level of urinary oxalate according to the sex 3- Determination and comparison of the average level of urinary oxalate according to the age 4- Determination and comparison of the average level of urinary oxalate according to patients BMI before surgery
Design
In this research, 105 eligible obese patients will be chosen from Alzahra hospital and Kashani Hospital with convenience sampling. Then, patients will be divided into 3 groups randomly.
Settings and conduct
In this research, obese patients between 18-60 years old referring to Isfahan Alzahra hospital and Kashani Hospital and undergo Roux-en-Y gastric bypass, Omega-loop gastric bypass and sleeve gastrectomy surgery were chosen. Then urine oxalate will be measured and compared to other groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent to participate; need to bariatric surgery; age between 18-60 years old. Exclusion criteria: History of the diseases that may be associated with hyperoxaluria such as Diabetes mellitus, IBD, primary hyperoxaluria and... based on patient history and cases; taking Hydrochlorothiazide medications; taking drugs that affect oxalate or calcium oxalate supersaturation; Lack of cooperation; pregnancy after surgery.
Intervention groups
Each group will undergo one surgical procedure: Roux-en-Y gastric bypass, Omega loop gastric bypass and sleeve gastrectomy
Main outcome variables
Determination and comparison of the average level of urinary oxalate after 3 surgical procedures: Roux-en-Y gastric bypass, Omega loop gastric bypass and sleeve gastrectomy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171118037525N1
Registration date: 2017-12-01, 1396/09/10
Registration timing: registered_while_recruiting

Last update: 2017-12-01, 1396/09/10
Update count: 0
Registration date
2017-12-01, 1396/09/10
Registrant information
Name
Flora Mazaheri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36246171
Email address
flora.mazaheri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative study of the mean urinary level of oxalate after Roux-n-Y gastric bypass, omega loop gastric bypass and sleeve gastrectomy in patients referred to Alzahra and Kashani hospital
Public title
Determination and comparison of urine oxalate after different bariatric surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in research need to bariatric surgery based on ASMBS(American society for metabolic and bariatric surgery) age between 18-60 years old
Exclusion criteria:
History of the diseases that may be associated with hyperoxaluria such as Diabetes mellitus, IBD, primary hyperoxaluria, hyperparathyroidism, chronic diarrhea, short bowel syndrome, liver disease, thyroid disease, immunological diseases, cancers, chronic renal failure, urinary tract infections, pregnancy and lactation based on patient history and cases taking Hydrochlorothiazide medications taking drugs that affect oxalate or calcium oxalate supersaturation Lack of cooperation pregnancy after surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling will be done and then samples will be separated to groups randomly via computer software
Blinding (investigator's opinion)
Not 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib avenue
City
Isfahan
Province
Isfehan
Postal code
6939177143
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
IR.MUI.REC.1396.3.502

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity

Primary outcomes

1

Description
24 hour urine oxalate
Timepoint
Before the intervention, 1 month after the intervention, 4 months after the intervention and 7 months after the intervention
Method of measurement
Enzymatic method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients undergo Roux-en-Y gastric bypass surgery
Category
Treatment - Surgery

2

Description
Intervention group: Patients undergo omega loop gastric bypass surgery
Category
Treatment - Surgery

3

Description
Intervention group: Patients undergo sleeve gastrectomy surgery
Category
Treatment - Surgery

4

Description
Control group: With no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Zeinab Balouchi
Street address
Ayatollah Kashani Hospital, Ayatollah Kashani st.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir
Web page address
http://kashani.mui.ac.ir

2

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Peyman Soleimani
Street address
Alzahra Hospital, Soffeh St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Attar
Street address
Isfahan University of Medical Sciences, Hezar jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Qods sq., Hezar jerib ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Fax
Email
drsayadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Qods sq., Hezar jerib ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Fax
Email
drsayadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Qods sq., Hezar jerib ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Fax
Email
drsayadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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