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comparison between primary closure and T-tube drainage after open choledochotomy

Protocol summary

Summary
The aim of this study is to assess the possibility of primary repair of common bile duct in choledocolithiasis to avoid T-tube placement and its probable complications. This study has been designed as a randomized controlled trial and will be conducted in two groups. Each group will be consisted of 15 patients. In the first group, after choledocotomy and drainage of choledocal stones, T-tube will be placed using the conventional method. In the second group, primary repair will be done instead of T-tube placement. Inclusion criteria is jaundice on physical examination or hyperbilirubinemia in the presence of gall stone disease, choledochal stones in ultrasonnography, endoscopic retrograde clangiopancreatography or magnetic resonance cholangiopancreatography, intraoperative palpation of stones in CBD. Exclusion critria is patients with acute pancreatitis or colangitis presentation, suspicious malignancy, lesser than 20 or older than 80 years old, patients with history of laparotomy, history of heart failure,renal failure, cerebrovascular accidents and myocardial infarction, obese patients with body mass index greater than 35. This study will be done during a 10-month period at the Department of General Surgery, Sina Hospital, Tabriz University of Medical Sciences. The entire patients will be assessed at 2-week, 3-week and 3-month intervals. Surgical complications including intra-abdominal collections, bile leak from drains, wound infection and remnant stone will be compared between the study groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012092410918N1
Registration date: 2012-12-10, 1391/09/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-12-10, 1391/09/20
Registrant information
Name
Abdolhamid Chavoshi Khamneh
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
chavoshiab@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between primary closure and T-tube drainage after open choledochotomy
Public title
new method in the treatment of choledochal stones
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: jaundice on physical examination or hyperbilirubinemia in the presence of gall stone disease; choledochal stones in ultrasonnography; ERCP or MRCP, intraoperative palpation of stones in CBD. exclusion critria: patients with acute pancreatitis or colangitis presentation; suspicious malignancy; lesser than 20 or older than 80 Y/O; patients with history of laparotomy; history of heart failure; renal failure; cerebrovascular accidents and myocardial infarction; obese patients with BMI>35.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tabriz University of Medical Siences
Street address
Gogasht Ave.-Tabriz University of Medical Siences
City
Tabriz
Postal code
Approval date
2012-04-30, 1391/02/11
Ethics committee reference number
5/4/3442

Health conditions studied

1

Description of health condition studied
choledochal stone treatment
ICD-10 code
K80.5
ICD-10 code description
Calculus of bile duct without cholangitis or cholecystitis

Primary outcomes

1

Description
biliary leak
Timepoint
During hospital stay,2 weeks,1 month, 3 months after surgery
Method of measurement
milliliter

2

Description
Intra-abdominal collections
Timepoint
1 month, 3 months after surgery
Method of measurement
ultrasonography

3

Description
residual stones
Timepoint
2 weeks,1 month, 3 months after surgery
Method of measurement
ultrasonography, T-tube colangiography

4

Description
wound infection
Timepoint
During hospital stay,2 weeks,1 month, 3 months after surgery
Method of measurement
suppurative secretions-Ratio

Secondary outcomes

1

Description
hospital stay
Timepoint
During admission
Method of measurement
day-calendar

2

Description
operating time
Timepoint
during admission
Method of measurement
hour

3

Description
time to removal of drain
Timepoint
during admission
Method of measurement
day-calendar

Intervention groups

1

Description
All patients undergo operation with right subcostal incision, then the vertical incision made in the CBD. The stones take out with stone forceps and saline flushing.complete clearace of CBD comfirm with intraoperative colangiograhy. Next, in control group; T-tube of appropriate size insert into the CBD incision and CBD incision will be closed using interrupted absorbable sutures.
Category
Treatment - Surgery

2

Description
In intervention group;after incision of CBD and extraction of stones and intraoperative colangiography; CBD will be closed primarily without T-tube insertion by interrupted absorbable sutures.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Abdolhamid Chavoshi khamneh,MD
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy Dean of Reseach,Tabriz University of Medical Siences
Full name of responsible person
Ali Meshkini, MD
Street address
Tariz-Gogasht Ave.
City
Tariz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Dean of Reseach,Tabriz University of Medical Siences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Abdolhamid Chavoshi Khamneh, MD
Full name of responsible person
Abdolhamid Chavoshi Khamneh, MD
Street address
Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abdolhamid Chavoshi Khamneh, MD
Proportion provided by this source
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 Siences
Full name of responsible person
Abdolhamid Chavoshi Khamneh,MD
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Tabriz- Golgasht Ave.
City
Tabriz
Postal code
Phone
+41 13341317
Fax
Email
chavoshiab@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tariz University of Medical Siences
Full name of responsible person
Alireza Barband, MD
Position
Assistant Professor of General Surgery
Other areas of specialty/work
Street address
Tabriz-Golgasht Ave.
City
Tabriz
Postal code
Phone
+41 15429060
Fax
Email
alibarband@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tariz University of Medical Siences
Full name of responsible person
Abdolhamid Chavoshi Khamneh,MD
Position
Resident of General Surgery
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
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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