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

Sponsor
Zhujiang Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02133027
Collaborator
(none)
60
1
2
12
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rouviere's sulcus
  • Device: surgical instruments
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Role of the Right Portal Pedicle and Rouviere's Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy in Chinese Population
Study Start Date :
Apr 1, 2014
Anticipated Primary Completion Date :
Apr 1, 2015
Anticipated Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rouviere's Sulcus

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.

Procedure: Rouviere's sulcus
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.

Device: surgical instruments
surgical instruments used in the laparoscopic cholecystectomy,such as ratcheted grasper,atraumatic grasper ,scissors.
Other Names:
  • Operating apparatus
  • Other: traditional anatomy method

    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.

    Device: surgical instruments
    surgical instruments used in the laparoscopic cholecystectomy,such as ratcheted grasper,atraumatic grasper ,scissors.
    Other Names:
  • Operating apparatus
  • Outcome Measures

    Primary Outcome Measures

    1. complication rate [one month]

      biliary injury,artery injury etc.

    Secondary Outcome Measures

    1. conversion rate [From date of randomization until the date of first documented progression ,assessed up to 12 months]

      The frequency of conversion to open surgery.

    Other Outcome Measures

    1. hospital stay [participants will be followed for the duration of hospital stay, an expected average of 1 weeks]

      The hospitalization time after operation

    2. blood loss [From date of randomization until the date of first documented progression ,assessed up to 12 months]

      the total amount of operation bleeding

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Hepatobiliary (I),Zhujiang Hospital Guangzhou Guangdong China 510280

    Sponsors and Collaborators

    • Zhujiang Hospital

    Investigators

    • Principal Investigator: Fan yi fang, Prof., Department of Hepatobiliary Surgery(I),Zhujiang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zhujiang Hospital
    ClinicalTrials.gov Identifier:
    NCT02133027
    Other Study ID Numbers:
    • Fanyingfang3
    First Posted:
    May 7, 2014
    Last Update Posted:
    May 7, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Zhujiang Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 7, 2014