Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05728073
• Collaborator: (none)
• Enrollment: 470
• Location: 1
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 311

Study Details

Study Description

Brief Summary

Study is designed to investigate whether the history of ERCP is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis.

Condition or Disease	Intervention/Treatment	Phase
Subtotal Cholecystectomy Rate; Conversion to Open	Procedure: ERCP

Detailed Description

The results of patients who underwent surgery for acute cholecystitis in a single center between January 2016 and December 2019 were included and evaluated retrospectively.

Patients that 18 years old and older are included in the study. Despite being operated with the diagnosis af acute cholecystitis, some of patients excluded:

• Initial and direct preferance of open method

• Being diagnosed with malignity after histopathological evaluation

• Being operated just before one week after ERCP or after more than six weeks after ERCP (with aiming to observe effects of ERCP obviously)

Primary outcome was subtotal cholecystectomy rate. Secondary outcomes were conversion to open, complications and serious complications. Within examining demographic findings, operative records (rates for subtotal cholecystectomy and conversion to open, operative duration) and follow-up results (postoperative complications, serious complications, length of hospital stay and mortality) for all cases were investigated. Complications that Clavien-Dindo Score ≥ 3 accepted as serious complication. Intraoperative detection of gallbladder perforation was also noted and included in comparison. Any biliary tract complication that needed any percutaneous or endoscopic intervention to handle was named as "biliary leak" in the study.

Study Design

• Study Type: Observational
• Actual Enrollment: 470 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?
• Actual Study Start Date: Dec 10, 2022
• Actual Primary Completion Date: Jan 10, 2023
• Actual Study Completion Date: Jan 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Standard (non-ERCP) Group Patients who underwent surgery for acute cholecystitis without a previous ERCP history.	Procedure: ERCP; Patients separated to two groups according to having a ERCP history before the operation
ERCP group Patients who underwent surgery for acute cholecystitis with a previous ERCP history.	Procedure: ERCP; Patients separated to two groups according to having a ERCP history before the operation

Outcome Measures

Primary Outcome Measures

1. Subtotal Cholecystectomy Rate [Intraoperative]

   Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy

Secondary Outcome Measures

1. Conversion to open [Intraoperative]

   Rate of patients needed conversion to open after initial intent of starting laparoscopic to the cholecystectomy

Other Outcome Measures

1. Complications [Postoperative first 90 days]

   Any complications experienced by patients who underwent emergency operation with the diagnosis of acute cholecystitis

2. Serious complications [Postoperative first 90 days]

   Any complications that has a Clavien-Dindo Score ≥ 3 experienced by patients who underwent emergency operation with the diagnosis of acute cholecystitis

3. Duration of operation [Intraoperative]

   Duration of emergency with the diagnosis of acute cholecystitis

4. Length of hospital stay [Postoperative first 90 days]

   Number of days patient stayed with and after the emergency operation with the diagnosis of acute cholecystitis

5. Mortality [Postoperative first 90 days]

   Number of patients that died after the emergency operation with the diagnosis of acute cholecystitis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients operated with the diagnosis of acute choelcystitis with an age greater or equal to 18 years old in a single center between January 2016 and December 2019

Exclusion Criteria:

• Initial and direct preferance of open method

• Being diagnosed with malignity after histopathological evaluation

• Being operated just before one week after ERCP or after more than six weeks after ERCP

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakırkoy Dr.Sadi Konuk Training and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Turgut Donmez, Ass. Prof. Dr., Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT05728073
• Other Study ID Numbers: 20230205
• First Posted: Feb 14, 2023
• Last Update Posted: Feb 14, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Turgut Donmez, Ass. Prof. Dr., Bakirkoy Dr. Sadi Konuk Research and Training Hospital: Acute Cholecystitis, Laparoscopic Cholecystectomy, Laparoscopic Subtotal Cholecystectomy, Endoscopic Retrograde Cholangiopancreatography
• Additional relevant MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute

Study Results

No Results Posted as of Feb 14, 2023