Enhanced Recovery After Surgery Program Versus Conventional Care for Laparoscopic Common Bile Duct Exploration
1 other identifier
interventional
228
1 country
2
Brief Summary
Laparoscopic common bile duct exploration (LCBDE) is a minimally invasive procedure to treat common bile duct stones (CBDS). Perioperative anxiety, hunger, thirst, fatigue, pain, nausea, and vomiting can influence a patient's recovery after surgery and prolong the in-hospital stay. Enhanced Recovery After Surgery (ERAS) is a modern concept that aims to improve perioperative patient care by implementing an evidence-based, patient-centered team approach. However, few reports focused on the safety and efficacy of the ERAS program in LCBDE. Therefore, this paper aims to compare the outcome of the ERAS program and conventional (C) care for patients undergoing LCBDE
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
2 active sites
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
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFirst Submitted
Initial submission to the registry
September 27, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedOctober 15, 2024
October 1, 2024
3.5 years
September 27, 2024
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lenghth of hospital stay
The duration from the surgery to discharge
1 - 30 days
Secondary Outcomes (1)
Postoperative complications
1 - 30 days
Study Arms (2)
ERAS-LCBDE
EXPERIMENTALPatients subjected to enhanced recovery after surgery care for laparoscopic common bile duct exploration
C-LCBDE
ACTIVE COMPARATORPatients subjected to conventional care for laparoscopic common bile duct exploration
Interventions
Enhanced recovery after surgery (ERAS) programs are a combination of evidenced-based perioperative care approaches that work synergistically to improve recovery after surgery. The core elements of ERAS protocols are preoperative advice, optimization of diet, systematic analgesic and anesthetic regimes, and early mobilization.
Conventional care for patients subjected for laparoscopic common bile duct exploration
Eligibility Criteria
You may qualify if:
- Patients diagnosed with CBDS
- American Society of Anesthesiologists (ASA) scores of I - II
- Age 20-70 years
You may not qualify if:
- Severe cholangitis
- Severe pancreatitis
- Mirizzi syndrome
- Perforated gallbladder
- Biliary peritonitis
- Intrahepatic stones
- Hepatobiliary malignancy
- Pregnancy
- Conversion to open surgery
- Previous upper abdominal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
South Valley University
Luxor, 83523, Egypt
South Valley University
Qina, 83523, Egypt
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marwa N Alansary, Lecturer
South Valley University
- PRINCIPAL INVESTIGATOR
Mohammed A Omar, Professor
South Valley University
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Mohammed Ahmed Omar
Study Record Dates
First Submitted
September 27, 2024
First Posted
October 8, 2024
Study Start
January 1, 2021
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share