Study of Left Side of Laparoscopic Cholecystectomy

NCT ID: NCT04078451

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholecystitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the experimental group

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.

Group Type EXPERIMENTAL

preserve the main cystic artery

Intervention Type PROCEDURE

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

the control group

treated with conventional laparoscopic cholecystectomy cutting the cystic artery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

preserve the main cystic artery

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Luhe Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Luhe Hospital affiliated to the Capital Medical University

Beijing, Tongzhou, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wei Han, Docter

Role: CONTACT

1350119597 ext. 13501195197

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wei Han, Doctor

Role: primary

13501195197

Haitao Sun, Master

Role: backup

13260030347

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-LHKY-001-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Laparoscopic Cholecystectomy:
NCT04107909 UNKNOWN NA
Laparoscopic Cholecystectomy After ERCP
NCT06197373 NOT_YET_RECRUITING