Protocol summary

Summary
This study was performed on all patients diagnosed with chronic renal failure that underwent kidney transplant surgery at Babol Shahid Beheshti hospital. After obtaining informed consent, patients were enrolled in census and were divided randomly into two groups. Group one and two operated by electrocautery and suture ligation of iliac lymphatic vessels respectively. Patients with history of pelvic radiotherapy and extensive surgery on lymphatics and patients with history of ipsilateral kidney transplant accompanying with contralateral pelvic surgery was excluded. All study cases was admitted in the transplant ward of Shahid Beheshti hospital before surgery, and exact paraclinical investigation including CBC, urine analysis, BUN, Cr, sonography of the kidney and urinary system by radiologist was done. All operations was done by one surgery team. Operation time and lymphatic closure time (both electrocautery and suture ligation) was documented by trained personnel. Patients was examined 2 to 7 days after surgery by a physician, and any signs of surgical site infection (erythema, swelling, discharge and pain) was noted and documented. Patients follow up for demonstration of fluid collection around the transplant kidney by ultra sonography was done one week, one month and three months post operatively. patientʼs data including gender, age, preoperative clinical and paraclinical data was collected. Other information of the patientʼs condition during admission such as vital signs, laboratory data and any change or complication (hydronephrosis, fluid collection, urinary tract infection,…) was collected and analysed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092129901N1
Registration date: 2017-05-16, 1396/02/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-16, 1396/02/26
Registrant information
Name
Abdolrahi Gholizadehpasha
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
a.gholizadehpasha@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Babol University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of electrocautery versus suture ligation of the iliac lymphatic on the fluid accumulation around the transplant kidney
Public title
comparing the effect of electrocautery versus suture ligation of the iliac lymphatic on the fluid accumulation around the transplant kidney
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with diagnosed of chronic renal failure that underwent kidney transplant surgery; with informed Consent. Exclusion criteria: patient with history of pelvic radiotherapy and extensive surgery on the pelvic lymphatics and patient with history of ipsilateral kidney transplant transplant accompanying with contralateral pelvic surgery.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
60 patients of this study was divided two groups (case and control) using randomly assigned.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol-Mazandaran- Iran
City
Babol
Postal code
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
MUBABOL.REC.1395.101

Health conditions studied

1

Description of health condition studied
Chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease:on dialysis

Primary outcomes

1

Description
Accumulation of fluid around the kidney transplant (Collection)
Timepoint
One week, one month and three months after surgery.
Method of measurement
Using Ultrasound

Secondary outcomes

1

Description
The need for drainage of the Collection
Timepoint
One week, one month and three months after surgery.
Method of measurement
Using Ultrasound

Intervention groups

1

Description
group one: Iliac lymphatic closure by using suture ligation with string
Category
Treatment - Surgery

2

Description
Group two: iliac lymphatics closure by using electrocautery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Abdolrahim Gholizadehpasha- Dr Abazar Akbarzadehpasha
Street address
Babol University of Medical sciences- Ganjafrooz street- Babol- Iran
City
Baboll

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of research , Babol University of Medical Sciences
Full name of responsible person
Dr.Aliakbar Moghaddamnia
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of research , Babol University of Medical Sciences
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
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehraban Faraji
Position
Resident of General Surgery
Other areas of specialty/work
Street address
update Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
bcrdc90@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Abdolrahim Gholizadehpasha
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
bcrdc90@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.akbarzadehpasha
Position
Associate Professor of Urology
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
bcrdc90@yahoo.com
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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