One Session Vs Staged Management of Calcular Obstructive Jaundice

• Sponsor: Minia University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05979233
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 6.5
• Patients Per Site Per Month: 16.8

Study Details

Study Description

Brief Summary

to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management

Condition or Disease	Intervention/Treatment	Phase
Calcular Obstructive Jaundice; Gall Bladder Disease	Procedure: staged managment; Procedure: one session ERCP then LC; Procedure: one session LC then ERCP	N/A

Detailed Description

to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: One Session Vs Staged Laropendoscopic Management of Calcular Obstructive Jaundice
• Anticipated Study Start Date: Aug 5, 2023
• Anticipated Primary Completion Date: Feb 15, 2024
• Anticipated Study Completion Date: Feb 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: staged managment ERCP then interval laparoscopic cholecystectomy	Procedure: staged managment; staged management
Experimental: one session ERCP then LC one session ERCP then LC	Procedure: one session ERCP then LC; one session ERCP then LC
Experimental: one session LC then ERCP one session LC then ERCP	Procedure: one session LC then ERCP; one session LC then ERCP

Outcome Measures

Primary Outcome Measures

1. total cost [6 months]

   total cost in Egyptian pound

2. hospital stay [6 months]

   total hospital stay in days

Secondary Outcome Measures

1. complications [30 days]

   early postoperative complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age from 18-70 year

• combined CBD and gall stone

• stone less than 1.5 cm

• fit for surgery

• no upper abdominal surgery

Exclusion Criteria:

• age <18 and >70

• unfit for surgery

• stone more than 1.5 cm

• upper abdominal surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Minya		Egypt	61511

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Mstafa Hassan Sewefy, MD, professor & consultant of general surgery, Department of surgery, Minia university hospital, Egypt, Minia University
• ClinicalTrials.gov Identifier: NCT05979233
• Other Study ID Numbers: fac.med.23.42
• First Posted: Aug 7, 2023
• Last Update Posted: Aug 8, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gallbladder Diseases; Urinary Bladder Diseases; Jaundice; Jaundice, Obstructive

Study Results

No Results Posted as of Aug 8, 2023