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Role of the Right Portal Pedicle and Rouviere's Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy

Primary Purpose

Gallstones, Cholecystitis, Polyps

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rouviere's sulcus
surgical instruments
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallstones focused on measuring Laparoscopic cholecystectomy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Hepatobiliary (I),Zhujiang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Rouviere's Sulcus

traditional anatomy method

Arm Description

Rouviere'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.

Ratcheted 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.

Outcomes

Primary Outcome Measures

complication rate
biliary injury,artery injury etc.

Secondary Outcome Measures

conversion rate
The frequency of conversion to open surgery.

Full Information

First Posted
April 28, 2014
Last Updated
May 3, 2014
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02133027
Brief Title
Role of the Right Portal Pedicle and Rouviere's Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy
Official Title
Role of the Right Portal Pedicle and Rouviere's Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy in Chinese Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Surgical procedures(Experimental group ):Placing the grasping forceps on the neck of the gallbladder, then retracted upwards and towards the left, so that the posterior aspect of the hepatobiliary triangle is exposed. the sulcus is seen running to the right of the hilum . In some patients, the lips of the sulcus are partially fused, with only a small cleft visible laterally. The sulcus indicates reliably the plane of the common bile duct; 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. Even if the bile duct is tented upwards by the traction that has been exerted on the gallbladder, dissection will be safely ventral to the plane of the duct. Posterior branches of the cystic artery, may lie in the area of dissection and must be identified with care.Once a plane has been opened posteriorly, attention may be turned to the anterior dissection, using the posterior landmarks as a guide. The anterior and posterior dissections can then be made to meet, thus opening the hepatobiliary triangle completely. Surgical procedures(Control group ):A small periumbilical incision is made, with the location and orientation depending on the patient's body habitus and cosmetic considerations.The laparoscope is used to explore the abdomen for adhesions and potential injuries that may have occurred during port placement,ratcheted 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. A hook cautery is used to carefully incise the peritoneum overlying the triangle of Calot, continuing along the medial aspect of the proximal gallbladder. As the infundibulum is retracted superomedially, peritoneum overlying the posterolateral aspect of the triangle of Calot is similarly incised using hook cautery. All remaining connective tissue is dissected out of the triangle of Calot using blunt dissection and hook cautery as needed to fully mobilize the gallbladder infundibulum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstones, Cholecystitis, Polyps
Keywords
Laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rouviere's Sulcus
Arm Type
Experimental
Arm Description
Rouviere'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.
Arm Title
traditional anatomy method
Arm Type
Other
Arm Description
Ratcheted 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.
Intervention Type
Procedure
Intervention Name(s)
Rouviere's sulcus
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
surgical instruments
Other Intervention Name(s)
Operating apparatus
Intervention Description
surgical instruments used in the laparoscopic cholecystectomy,such as ratcheted grasper,atraumatic grasper ,scissors.
Primary Outcome Measure Information:
Title
complication rate
Description
biliary injury,artery injury etc.
Time Frame
one month
Secondary Outcome Measure Information:
Title
conversion rate
Description
The frequency of conversion to open surgery.
Time Frame
From date of randomization until the date of first documented progression ,assessed up to 12 months
Other Pre-specified Outcome Measures:
Title
hospital stay
Description
The hospitalization time after operation
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 weeks
Title
blood loss
Description
the total amount of operation bleeding
Time Frame
From date of randomization until the date of first documented progression ,assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang li qing, Doctor
Phone
+86-02062783391
Email
wliqing07@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan yi fang, Prof.
Organizational Affiliation
Department of Hepatobiliary Surgery(I),Zhujiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hepatobiliary (I),Zhujiang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan yi fang, Prof.

12. IPD Sharing Statement

Citations:
PubMed Identifier
24319350
Citation
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.
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Role of the Right Portal Pedicle and Rouviere's Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy

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