Study of Left Side of Laparoscopic Cholecystectomy
Primary Purpose
Cholecystitis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
preserve the main cystic artery
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring cholecystectomy, Laparoscopic
Eligibility Criteria
Inclusion Criteria:
- consistent with the indications of cholecystectomy
- no cholangitis or pancreatitis
- no diabetes
- the operation time is less than or equal to 1 hour
Exclusion Criteria:
- patients with acute cholecystitis
- cystic arterial variation causes related complications
- patients receiving analgesic drugs after surgery
Sites / Locations
- Beijing Luhe Hospital affiliated to the Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
the experimental group
the control group
Arm Description
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.
treated with conventional laparoscopic cholecystectomy cutting the cystic artery
Outcomes
Primary Outcome Measures
Operation time
Compare the operation time between the two operations
intraoperative blood loss
Compare the amount of blood loss during the two operations
incidence of surgical complications
delayed hemorrhage, biliary tract injury, etc.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04078451
Brief Title
Study of Left Side of Laparoscopic Cholecystectomy
Official Title
The Clinical Study of Laparoscopic Cholecystectomy With the Preservation of the Main Cystic Artery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Luhe Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
Keywords
cholecystectomy, Laparoscopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
the control group
Arm Type
No Intervention
Arm Description
treated with conventional laparoscopic cholecystectomy cutting the cystic artery
Intervention Type
Procedure
Intervention Name(s)
preserve the main cystic artery
Intervention Description
The experimental group preserve the main cystic artery, and the control group cut off the main cystic artery
Primary Outcome Measure Information:
Title
Operation time
Description
Compare the operation time between the two operations
Time Frame
One hour to 24 hours after surgery
Title
intraoperative blood loss
Description
Compare the amount of blood loss during the two operations
Time Frame
One hour to 24 hours after surgery
Title
incidence of surgical complications
Description
delayed hemorrhage, biliary tract injury, etc.
Time Frame
One hour to 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
consistent with the indications of cholecystectomy
no cholangitis or pancreatitis
no diabetes
the operation time is less than or equal to 1 hour
Exclusion Criteria:
patients with acute cholecystitis
cystic arterial variation causes related complications
patients receiving analgesic drugs after surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Han, Docter
Phone
1350119597
Ext
13501195197
Email
dr-han@vip.sina.com
Facility Information:
Facility Name
Beijing Luhe Hospital affiliated to the Capital Medical University
City
Beijing
State/Province
Tongzhou
ZIP/Postal Code
101149
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Han, Doctor
Phone
13501195197
Email
dr-han@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Haitao Sun, Master
Phone
13260030347
Email
13260030347@163.com
First Name & Middle Initial & Last Name & Degree
Jiahui Qi, Bachelor
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Left Side of Laparoscopic Cholecystectomy
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