CholecystitisNCT04078451
Study of Left Side of Laparoscopic Cholecystectomy
A study testing preserve the main cystic artery in people with Cholecystitis, run by Beijing Luhe Hospital at 1 site in China.
Trial summary
Prospectively selected 100 cases of patients who suffered from gallstones ro cholecystic polypus and treated with laparoscopic cholecystectomy in our hospital. Randomly divided into the experimental group and the control group. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- preserve the main cystic artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2020to 30 Jun 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- consistent with the indications of cholecystectomy
- no cholangitis or pancreatitis
- no diabetes
- the operation time is less than or equal to 1 hour
Who cannot join
- patients with acute cholecystitis
- cystic arterial variation causes related complications
- patients receiving analgesic drugs after surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Luhe Hospital affiliated to the Capital Medical University
Beijing, Tongzhou, 101149
Wei Han, Doctor, 13501195197, dr-han@vip.sina.com
Haitao Sun, Master, 13260030347, 13260030347@163.com
About this study
Official title: The Clinical Study of Laparoscopic Cholecystectomy With the Preservation of the Main Cystic Artery
Prospectively selected 100 cases of patients who suffered from gallstones ro cholecystic polypus and treated with laparoscopic cholecystectomy in our hospital. Randomly divided into the experimental group and the control group. The experimental group preserve the main cystic artery, and the control group treated with conventional laparoscopic cholecystectomy. Collection of statistics: including general data(gender, age, BMI, etc.), time of surgery, intraoperative blood loss, incidence of surgical complications (delayed hemorrhage, biliary injury, etc.) and postoperative pain score, etc.
Read the detailed description
- research object (1)patients who suffered from gallstones ro cholecystic polypus. (2)Informed and consented to participate in this clinical trial (3)Number of enrolled cases：100.（About 700 cases were treated in our hospital）
- Inclusion criteria (1) consistent with the indications of cholecystectomy (2) no cholangitis or pancreatitis (3) no diabetes (4) the operation time is less than or equal to 1 hour 3.Exclusion criteria
- patients with acute cholecystitis
- cystic arterial variation causes related complications
- patients receiving analgesic drugs after surgery 4.research methods 4.1 Grouping method: random number table method was applied to randomly divide into 2 groups.
4.2 surgical method：Laparoscopic cholecystectomy with the preservation of the main cystic artery
- General anesthesia, use laryngeal mask
- making CO2 pneumoperitoneum through the superior border of umbilical pneumoperitoneum pressure 12 -- 14 mmHg(1 mmHg=0.(133 kPa), the puncture sleeve was placed under laparoscopy according to the three-hole method.
- To expose the gallbladder triangle, cut the serous membrane of the triangular region along the gallbladder tube, expose the neck and the left half of the gallbladder tube, push the rest tissue of the triangular region (including the main cystic artery, etc.) to the right, and separate the right half of the gallbladder tube, exposing the whole gallbladder tube.
- Cutting off after clipping the gallbladder tube;
- Turn up the gallbladder neck, cut off the superficial and deep branches of the gallbladder artery by electric hook along the gallbladder wall.
- Remove the gallbladder. through the umbilical hole and close the puncture hole. 4.3 main outcome measures (1) General data of patients (gender, age, BMI, etc.); (2) Operation time, intraoperative blood loss, surgical complications (delayed hemorrhage, biliary tract injury, etc.) incidence.
- Conditions
- Cholecystitis
- Being tested
- preserve the main cystic artery
- Keywords
- cholecystectomy, Laparoscopic
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preserve the main cystic arteryProcedure or surgery
The experimental group preserve the main cystic artery, and the control group cut off the main cystic artery
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | The experimental group operated by the left side of laparoscopic cholecystectomy preserving the main cystic artery.
The operation area of cystic artery dissection is moved from the traditional triangular area to the gallbladder neck plane, away from the hepatic duct and hepatic portal.Only the superficial and even more minute branches of the cystic artery were isolated and coagulated. Receives: Procedure: preserve the main cystic artery |
| the control group | No intervention | treated with conventional laparoscopic cholecystectomy cutting the cystic artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Compare the operation time between the two operations
Measured: One hour to 24 hours after surgery
intraoperative blood loss
Compare the amount of blood loss during the two operations
Measured: One hour to 24 hours after surgery
incidence of surgical complications
delayed hemorrhage, biliary tract injury, etc.
Measured: One hour to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start30 Jun 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Luhe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078451
- Sponsor's protocol ID
- 2018-LHKY-001-02
- Status last verified
- Jun 2020
- First submitted
- 18 Nov 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Laparoscopic Cholecystectomy With the Preservation of the Main Cystic Artery
- ClinicalTrials.gov ID
- NCT04078451
- Acronym / sponsor ID
- 2018-LHKY-001-02
- Conditions
- Cholecystitis
- Keywords
- cholecystectomy, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Luhe HospitalUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 Sep 2019 (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.
Prospectively selected 100 cases of patients who suffered from gallstones ro cholecystic polypus and treated with laparoscopic cholecystectomy in our hospital. Randomly divided into the experimental group and the control group. The experimental group preserve the main cystic artery, and the control group treated with conventional laparoscopic cholecystectomy. Collection of statistics: including general data(gender, age, BMI, etc.), time of surgery, intraoperative blood loss, incidence of surgical complications (delayed hemorrhage, biliary injury, etc.) and postoperative pain score, etc.
Detailed description
- research object (1)patients who suffered from gallstones ro cholecystic polypus. (2)Informed and consented to participate in this clinical trial (3)Number of enrolled cases：100.（About 700 cases were treated in our hospital）
- Inclusion criteria (1) consistent with the indications of cholecystectomy (2) no cholangitis or pancreatitis (3) no diabetes (4) the operation time is less than or equal to 1 hour 3.Exclusion criteria
- patients with acute cholecystitis
- cystic arterial variation causes related complications
- patients receiving analgesic drugs after surgery 4.research methods 4.1 Grouping method: random number table method was applied to randomly divide into 2 groups.
4.2 surgical method：Laparoscopic cholecystectomy with the preservation of the main cystic artery
- General anesthesia, use laryngeal mask
- making CO2 pneumoperitoneum through the superior border of umbilical pneumoperitoneum pressure 12 -- 14 mmHg(1 mmHg=0.(133 kPa), the puncture sleeve was placed under laparoscopy according to the three-hole method.
- To expose the gallbladder triangle, cut the serous membrane of the triangular region along the gallbladder tube, expose the neck and the left half of the gallbladder tube, push the rest tissue of the triangular region (including the main cystic artery, etc.) to the right, and separate the right half of the gallbladder tube, exposing the whole gallbladder tube.
- Cutting off after clipping the gallbladder tube;
- Turn up the gallbladder neck, cut off the superficial and deep branches of the gallbladder artery by electric hook along the gallbladder wall.
- Remove the gallbladder. through the umbilical hole and close the puncture hole. 4.3 main outcome measures (1) General data of patients (gender, age, BMI, etc.); (2) Operation time, intraoperative blood loss, surgical complications (delayed hemorrhage, biliary tract injury, etc.) incidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group | Experimental | Procedure: preserve the main cystic arteryThe experimental group operated by the left side of laparoscopic cholecystectomy preserving the main cystic artery. The operation area of cystic artery dissection is moved from the traditional triangular area to the gallbladder neck plane, away from the hepatic duct and hepatic portal.Only the superficial and even more minute branches of the cystic artery were isolated and coagulated. |
| the control group | No intervention | –treated with conventional laparoscopic cholecystectomy cutting the cystic artery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- consistent with the indications of cholecystectomy
- no cholangitis or pancreatitis
- no diabetes
- the operation time is less than or equal to 1 hour
Key exclusion criteria (3 listed)
- patients with acute cholecystitis
- cystic arterial variation causes related complications
- patients receiving analgesic drugs after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preserve the main cystic arteryThe experimental group preserve the main cystic artery, and the control group cut off the main cystic artery | Procedure or surgery | the experimental group |
Primary outcome
Operation time
Time frame: One hour to 24 hours after surgery
Compare the operation time between the two operations
intraoperative blood loss
Time frame: One hour to 24 hours after surgery
Compare the amount of blood loss during the two operations
incidence of surgical complications
Time frame: One hour to 24 hours after surgery
delayed hemorrhage, biliary tract injury, etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preserve the main cystic artery in people with Cholecystitis, run by Beijing Luhe 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 4 inclusion and 3 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 11 Jun 2020. 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 Wei Han, Docter (1350119597 ext. 13501195197, dr-han@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: One hour to 24 hours after surgery). The study lists 3 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 11 Jun 2020.