Study of Left Side of Laparoscopic Cholecystectomy

Cholecystitis Clinical Trial

Official title:

The Clinical Study of Laparoscopic Cholecystectomy With the Preservation of the Main Cystic Artery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04078451
• Other study ID #: 2018-LHKY-001-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2020
• Source: Beijing Luhe Hospital
• Contact: Wei Han, Docter
• Phone: 1350119597
• Email: dr-han[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

1. 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）

2. 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

1. patients with acute cholecystitis

2. cystic arterial variation causes related complications

3. 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

1. General anesthesia, use laryngeal mask

2. 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.

3. 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.

4. Cutting off after clipping the gallbladder tube;

5. Turn up the gallbladder neck, cut off the superficial and deep branches of the gallbladder artery by electric hook along the gallbladder wall.

6. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Exclusion Criteria:

1. patients with acute cholecystitis

2. cystic arterial variation causes related complications

3. patients receiving analgesic drugs after surgery

Related Conditions & MeSH terms

• Cholecystitis

Intervention

Procedure:
• preserve the main cystic artery
The experimental group preserve the main cystic artery, and the control group cut off the main cystic artery

Locations

Country	Name	City	State
China	Beijing Luhe Hospital affiliated to the Capital Medical University	Beijing	Tongzhou

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Luhe Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	Compare the operation time between the two operations	One hour to 24 hours after surgery
Primary	intraoperative blood loss	Compare the amount of blood loss during the two operations	One hour to 24 hours after surgery
Primary	incidence of surgical complications	delayed hemorrhage, biliary tract injury, etc.	One hour to 24 hours after surgery