NCT04078451

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

November 18, 2018

Last Update Submit

June 11, 2020

Conditions

Keywords

cholecystectomyLaparoscopic

Outcome Measures

Primary Outcomes (3)

  • Operation time

    Compare the operation time between the two operations

    One hour to 24 hours after surgery

  • intraoperative blood loss

    Compare the amount of blood loss during the two operations

    One hour to 24 hours after surgery

  • incidence of surgical complications

    delayed hemorrhage, biliary tract injury, etc.

    One hour to 24 hours after surgery

Study Arms (2)

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.

Procedure: preserve the main cystic artery

the control group

NO INTERVENTION

treated with conventional laparoscopic cholecystectomy cutting the cystic artery

Interventions

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

the experimental group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • consistent with the indications of cholecystectomy
  • no cholangitis or pancreatitis
  • no diabetes
  • the operation time is less than or equal to 1 hour

You may not qualify if:

  • patients with acute cholecystitis
  • cystic arterial variation causes related complications
  • patients receiving analgesic drugs after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Luhe Hospital affiliated to the Capital Medical University

Beijing, Tongzhou, 101149, China

Location

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Central Study Contacts

Wei Han, Docter

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2018

First Posted

September 6, 2019

Study Start

June 30, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations