Role of the Right Portal Pedicle and Rouviere's Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy
1 other identifier
interventional
60
1 country
1
Brief Summary
Objective:To explore the role of the right portal pedicle and Rouviere's sulcus as an anatomic landmark in laparoscopic cholecystectomy. Methods:The investigators are going to select 60 patients intending to perform Laparoscopic cholecystectomy from April 2014 to April 2015.Check out the presence of the right portal pedicle and Rouviere's sulcus during the surgery and divide into the experimental group and the control group.Experimental group operated in Laparoscopic cholecystectomy with the guide of Rouviere's sulcus while the Control group operated with the traditional way. Research hypothesis:Compare the differences between the Experimental group and the Control group in bile duct injury rate,complication rate,blood loss,operative time ,conversion rate and hospital stay.It is supposed that the results of Experimental group are superior to the control group,difference is statistically significant(P\<0.05). So the investigators can draw the conclusion that the anatomy method with the guide of right portal pedicle and Rouviere's sulcus is useful in laparoscopic cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 7, 2014
May 1, 2014
1 year
April 28, 2014
May 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complication rate
biliary injury,artery injury etc.
one month
Secondary Outcomes (1)
conversion rate
From date of randomization until the date of first documented progression ,assessed up to 12 months
Other Outcomes (2)
hospital stay
participants will be followed for the duration of hospital stay, an expected average of 1 weeks
blood loss
From date of randomization until the date of first documented progression ,assessed up to 12 months
Study Arms (2)
Rouviere's Sulcus
EXPERIMENTALRouviere's sulcus is a 2 to 5 cm sulcus running to the right of the liver hilum anterior to the caudate process and usually containing the right portal triad or its branches.Dissection may be started safely by division of the peritoneum immediately ventral to the sulcus and continued in a triangle bounded by the liver surface, the neck of the gallbladder and the plane of the sulcus.
traditional anatomy method
OTHERRatcheted grasper is inserted through the lateral 5-mm port to retract the gallbladder fundus in cephalad fashion. An atraumatic grasper is inserted through the middle 5-mm port to retract the gallbladder infundibulum laterally, exposing the anteromedial aspect of the triangle of Calot.
Interventions
Dissection may be started safely by division of the peritoneum immediately ventral to the sulcus and continued in a triangle bounded by the liver surface, the neck of the gallbladder and the plane of the sulcus.
surgical instruments used in the laparoscopic cholecystectomy,such as ratcheted grasper,atraumatic grasper ,scissors.
Eligibility Criteria
You may qualify if:
- Symptomatic gallstones
- Gallstones\>3cm in diameter
- Fulfilled gallstones
- Acute or chronic cholecystitis
- Acalculous cholecystitis
- Gallbladder polyps \>10mm in diameter
- Symptomatic gallbladder polyps
- Gallbladder stones associated with polyps
- Porcelain gallbladder
- Gallstone pancreatitis
You may not qualify if:
- Suspicion of gallbladder cancer
- General condition is poor,inability to tolerate gallbladder cancer
- Important organ dysfunction
- Severe abdominal cavity adhesion
- Bleeding disorders,blood coagulation dysfunction
- Acute cholangitis with serious complications(gallbladder empyema,gangrene,perforation)
- Acute cholangitis
- Pregnancy(first or third trimester)
- Abdominal dysfunction or peritonitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hepatobiliary (I),Zhujiang Hospital
Guangzhou, Guangdong, 510280, China
Related Publications (1)
Dahmane R, Morjane A, Starc A. Anatomy and surgical relevance of Rouviere's sulcus. ScientificWorldJournal. 2013 Nov 6;2013:254287. doi: 10.1155/2013/254287. eCollection 2013.
PMID: 24319350BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fan yi fang, Prof.
Department of Hepatobiliary Surgery(I),Zhujiang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
May 7, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 7, 2014
Record last verified: 2014-05