Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT04181801

Conditions

Subtotal Cholecystectomy

Complicated Acute Cholecystitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Subtotal cholecystectomy

Study Details

Brief summary:

We believe that subtotal cholecystectomy is a safe alternative to total cholecystectomy when the complicated gallbladder is encountered, resulting in decreased or equivalent risk of bile duct injury, major vascular injury, postoperative hemorrhage, infectious complications, and mortality. Additionally, we hope to further elucidate the expected outcomes of the varying subtypes of subtotal cholecystectomy in order to determine the safest approach, assuring the lowest need for secondary intervention, recurrent biliary disease, or need for a completion cholecystectomy.

Conditions

Subtotal Cholecystectomy

Complicated Acute Cholecystitis

Study ID

NCT04181801

Start date

Nov 8, 2019

Status verified date

Feb, 2022

Completion date

Nov, 2022

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • Preoperative definitive diagnosis of acute cholecystitis (Tokyo guideline: Table 1)

Exclusion Criteria:

  • Pregnant patients
  • Prior history of subtotal cholecystectomy
  • Percutaneous cholecystostomy tube in place
  • Preoperative diagnosis other than acute cholecystitis
  • Symptomatic cholelithiasis
  • Gallstone pancreatitis
  • Choledocholithiasis
  • Malignant/benign tumor
  • Others

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

Subtotal cholecystectomy

a surgical procedure in which more than the top half of the gallbladder is removed

Primary outcome measure

  • Incidence of post-operative complications and mortality [ Time Frame: oct 2019 - sept 2021 ]

Central Contacts and Locations

Central contacts

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

More Information

Sponsor

Methodist Health System

Last update posted

Feb 25, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Health System on 2022-02-25.