Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04150679 |
| Other study ID # |
Hazem Nour access loop |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2013 |
| Est. completion date |
May 2019 |
Study information
| Verified date |
October 2019 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A comparative study between two groups, group I; retrospective group, 21 patients underwent
hepaticojejunostomy for treatment of iatrogenic bile duct injuries without access loop, in
the period between January 2013 and December 2014, group II; a prospective group, 23 patients
underwent hepaticojejunostomy for iatrogenic bile duct injuries with duodenojejunostomy as a
permanent access loop, in the period between June 2017 and May 2019. Primary (early and late
outcome) and management of complications data were collected and analyzed properly.
Description:
This study is a comparative study, comparing between two groups of patients with post
cholecystectomy biliary injury, group (I) 21 patients, a retrospective group where data was
collected from the medical records of the patients presented with post cholecystectomy
biliary injury and managed with hepaticojejunostomy without access loop in a period of 2
years between January 2013 and December 2014, and group (II) 23 patients, a prospective
group, where patients presented with post cholecystectomy biliary injury in a 2 years period
between January 2017 and December 2018 , and managed by hepaticojejunostomy and
jejunoduodenostomy as a permanent access loop .
the data collected from both groups included, demographic criteria of patients, type of the
previous surgery, place of surgery, the class of the biliary injury according to bismuth
classification, (according to Bismuth classification; type I (Low injury, stump length > 2
cm), type II) (higher injury, stump length < 2 cm), type III (high CHD injury but confluence
is preserved), type IV (high injury both hepatic ducts are no more connected.). And any
diagnostic or therapeutic intervention carried out before surgical management.
The detailed surgical management; in group I a roux en y hepaticojejunostomy was done, after
abdominal exploration and identification of the level of injury or stricture a ROUX en Y loop
of the jejunum was prepared 40 cm post duodenojujenal junction, it was separated and
anastomosed to the jejunum at a more distal point ( 60 cm ) the proximal end of the distal
loop was closed in two layers with Vicryl 3\0 the loop was extracted retrocolic towards the
site of injury where a hepaticojejunostomy was done end( biliary)to side (jejunum with Vicryl
4\0 size single layer .
in the second group the same was done but with jejunoduodenostomy side to side at 5-10 cm
distal to the site of hepaticoduodenostomy as a permanent access loop.
Follow up data either clinical, laboratory or radiologic were collected, findings of MRCP (if
needed) was reported as primary outcome.
Secondary outcome (management of complications), including the operative time needed for
correction of the complications, early and late postoperative morbidity and mortality.
The data was analyzed properly using SPSS 18, and presented in a suitable way using graphs
figures and tables.
