CholelithiasisNCT05002426
Rouviere Sulcus Plane and Hepatic Hilum Plane, Which is Better as a Landmark in Laparoscopic Bile Duct Surgerys
An observational study of Cholelithiasis and Laparoscopic Cholecystectomy, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
RS and the RS plane are important anatomical markers in laparoscopic cholecystectomy. However, there are many variations in the shape and orientation of the RS, and the RS plane is an imaginary plane, which can be misjudged by different surgeons. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholelithiasis, Laparoscopic Cholecystectomy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2021to 1 Oct 2021
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: a consecutive patients undergoing elective laparoscopic cholecystectomies at the second affiliated hospital of Anhui medical university
Who may be able to join
- Benign disease of the gallbladder requires surgery
Who cannot join
- Patients with severe cirrhosis or had a history of partial hepatectomy were excluded from the statistics .
- patients with unexpected gallbladder carcinoma.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Wang
Hefei, Anhui, 230601
lei wang, MD, 15156086983, wl9252@126.com
About this study
RS and the RS plane are important anatomical markers in laparoscopic cholecystectomy. However, there are many variations in the shape and orientation of the RS, and the RS plane is an imaginary plane, which can be misjudged by different surgeons. The purpose of this study is to introduce a more intuitive anatomical marker and anatomical plane, hilum plane, and discuss the application value of hilum plane in laparoscopic biliary surgery by comparing it with RS and RS plane.
Read the detailed description
Hepatic hilum plane is the hepatoduodenal serosa plane that extends from the base of the liver IVa segment down to the first segment of the gallbladder triangle.
During the operation, first pulling the gallbladder to the head side, using the separating forceps to slide down horizontally from the hilum (the basement of hepatic segment Ⅳ), and along the serous of hepatoduodenal ligament, that is so called "hilum plane".
It forms a "neck-shoulder" structure when the hilar plane meets the tent-like hepatobiliary triangle. the serosa of hepatobiliary triangle was dissected on the neck area and ventral side of hilar plane, and the serosa of posterior triangle of the gallbladder was also cutted on the same extension line . In this process, the type and orientation of RS, the relationship between the plane of the RS sulcus and the plane of the hilar plane were also recorded and compared with hilum plane.
- Conditions
- Cholelithiasis, Laparoscopic Cholecystectomy
- Keywords
- anatomy
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The type and orientation of Rouviere sulcus | "open type", "fused type" or "absent type" |
What is being measured
The primary outcome is the main question the study is designed to answer.
The type of Rouviere sulcus and the "fake RS"
The Rouviere sulcus was present if a fissure was seen in the liver parenchyma on the right side of the gallbladder and continues with the right posterior hepatic pedicle(fig ). RS were further subdivided into three classes: "open type", "fused type" or "absent type"). The "plane of RS sulcus" was also recorded If the RS was not the absent type.
Measured: up to 30 days after surgery
The orientation of RS and The relationship between hepatic portal plane and RS plane
the RS plane is an imaginary line drawn along the sulcus and carried across to the base of segment IV and form a "security triangle". Similarly, the hilar plane can also form a triangle in posterior triangle of gallbladder. The areas of these triangles were Compared.
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start4 Jan 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hui hou, The Second Hospital of Anhui Medical University
- Investigators
- hui hou, master, Study chair, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002426
- Sponsor's protocol ID
- 1458
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rouviere Sulcus Plane and Hepatic Hilum Plane, Which is Better as a Landmark in Laparoscopic Bile Duct Surgerys
- ClinicalTrials.gov ID
- NCT05002426
- Acronym / sponsor ID
- 1458
- Conditions
- Cholelithiasis, Laparoscopic Cholecystectomy
- Keywords
- anatomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RS and the RS plane are important anatomical markers in laparoscopic cholecystectomy. However, there are many variations in the shape and orientation of the RS, and the RS plane is an imaginary plane, which can be misjudged by different surgeons. The purpose of this study is to introduce a more intuitive anatomical marker and anatomical plane, hilum plane, and discuss the application value of hilum plane in laparoscopic biliary surgery by comparing it with RS and RS plane.
Detailed description
Hepatic hilum plane is the hepatoduodenal serosa plane that extends from the base of the liver IVa segment down to the first segment of the gallbladder triangle.
During the operation, first pulling the gallbladder to the head side, using the separating forceps to slide down horizontally from the hilum (the basement of hepatic segment Ⅳ), and along the serous of hepatoduodenal ligament, that is so called "hilum plane".
It forms a "neck-shoulder" structure when the hilar plane meets the tent-like hepatobiliary triangle. the serosa of hepatobiliary triangle was dissected on the neck area and ventral side of hilar plane, and the serosa of posterior triangle of the gallbladder was also cutted on the same extension line . In this process, the type and orientation of RS, the relationship between the plane of the RS sulcus and the plane of the hilar plane were also recorded and compared with hilum plane.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The type and orientation of Rouviere sulcus | – | –"open type", "fused type" or "absent type" |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a consecutive patients undergoing elective laparoscopic cholecystectomies at the second affiliated hospital of Anhui medical university
Key inclusion criteria (1 listed)
- Benign disease of the gallbladder requires surgery
Key exclusion criteria (2 listed)
- Patients with severe cirrhosis or had a history of partial hepatectomy were excluded from the statistics .
- patients with unexpected gallbladder carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The type of Rouviere sulcus and the "fake RS"
Time frame: up to 30 days after surgery
The Rouviere sulcus was present if a fissure was seen in the liver parenchyma on the right side of the gallbladder and continues with the right posterior hepatic pedicle(fig ). RS were further subdivided into three classes: "open type", "fused type" or "absent type"). The "plane of RS sulcus" was also recorded If the RS was not the absent type.
The orientation of RS and The relationship between hepatic portal plane and RS plane
Time frame: up to 30 days after surgery
the RS plane is an imaginary line drawn along the sulcus and carried across to the base of segment IV and form a "security triangle". Similarly, the hilar plane can also form a triangle in posterior triangle of gallbladder. The areas of these triangles were Compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hui hou, master study chair
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis and Laparoscopic Cholecystectomy, run by The Second Hospital of Anhui Medical University 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 1 inclusion and 2 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 12 Aug 2021. 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 lei wang, MD (+8615156086983, wl9252@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The type of Rouviere sulcus and the "fake RS" (time frame: up to 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2021.