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new method in the treatment of choledochal stones

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012092410918N1
Enrollment
30
Registered
2012-12-10
Start date
2012-03-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

choledochal stone treatment. Calculus of bile duct without cholangitis or cholecystitis

Interventions

Intervention 1: 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
T-tube of appropriate size insert into the CBD incision and CBD incision will be closed using interrupted absorbable sutures. Intervention 2: 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.
Treatment - Surgery
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
T-tube of appropriate size insert into the CBD incision and CBD incision will be closed using interrupted absorbable sutures.
In intervention group

Sponsors

Deputy Dean of Reseach,Tabriz University of Medical Siences
Lead Sponsor
Abdolhamid Chavoshi Khamneh, MD
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Biliary leak. Timepoint: During hospital stay,2 weeks,1 month, 3 months after surgery. Method of measurement: milliliter.;Intra-abdominal collections. Timepoint: 1 month, 3 months after surgery. Method of measurement: ultrasonography.;Residual stones. Timepoint: 2 weeks,1 month, 3 months after surgery. Method of measurement: ultrasonography, T-tube colangiography.;Wound infection. Timepoint: During hospital stay,2 weeks,1 month, 3 months after surgery. Method of measurement: suppurative secretions-Ratio.

Secondary

MeasureTime frame
Hospital stay. Timepoint: During admission. Method of measurement: day-calendar.;Operating time. Timepoint: during admission. Method of measurement: hour.;Time to removal of drain. Timepoint: during admission. Method of measurement: day-calendar.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbdolhamid Chavoshi Khamneh,MD

Tabriz University of Medical Siences

chavoshiab@tbzmed.ac.ir+41 13341317

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026