AzTrials
AzTrials

GallstonesNCT02133027

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

A study testing Rouviere's sulcus and surgical instruments in people with Gallstones and Cholecystitis, run by Zhujiang Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Gallstones, Cholecystitis, Polyps
What is being tested?
Rouviere's sulcus and surgical instruments
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Apr 2014to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic gallstones
  • Gallstones>3cm in diameter
  • Fulfilled gallstones
  • Acute or chronic cholecystitis
  • Acalculous cholecystitis
  • Gallbladder polyps >10mm in diameter
Show all 10Show fewer
  • Symptomatic gallbladder polyps
  • Gallbladder stones associated with polyps
  • Porcelain gallbladder
  • Gallstone pancreatitis

Who cannot join

  • 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)
Show all 9Show fewer
  • Acute cholangitis
  • Pregnancy(first or third trimester)
  • Abdominal dysfunction or peritonitis

Trial locations and contacts

1 site in 1 country.

Wang li qing, Doctor contact

+86-02062783391

wliqing07@gmail.com

China1 site, 1 recruiting
  • Department of Hepatobiliary (I),Zhujiang Hospital

    Guangzhou, Guangdong, 510280

    Fan yi fang, Prof.

    Recruiting

Other trials in China

About this study

Official title: Role of the Right Portal Pedicle and Rouviere's Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy in Chinese Population

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.

Read the 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.

Being tested
Rouviere's sulcus, surgical instruments
Keywords
Laparoscopic cholecystectomy
Medical subject headings
Gallstones, Cholecystitis, Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rouviere's sulcusProcedure or surgery

    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 instrumentsDevice

    Also called Operating apparatus

    surgical instruments used in the laparoscopic cholecystectomy,such as ratcheted grasper,atraumatic grasper ,scissors.

Study groups in NCT02133027
Study groupRoleWhat they receive
Rouviere's SulcusExperimentalRouviere'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.
Receives: Procedure: Rouviere's sulcus; Device: surgical instruments
traditional anatomy methodOtherRatcheted 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.
Receives: Device: surgical instruments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complication rate

    biliary injury,artery injury etc.

    Measured: one month

Secondary outcomes (1)
  1. conversion rate

    The frequency of conversion to open surgery.

    Measured: From date of randomization until the date of first documented progression ,assessed up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2015 (estimated)
  4. Study completionApr 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133027
Sponsor's protocol ID
Fanyingfang3
Status last verified
May 2014
First submitted
28 Apr 2014
Last updated
7 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24319350

Questions about this trial

What is this clinical trial studying?

A study testing Rouviere's sulcus and surgical instruments in people with Gallstones and Cholecystitis, run by Zhujiang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wang li qing, Doctor (+86-02062783391, wliqing07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complication rate (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02133027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in