CholedocholithiasisNCT06630767
Enhanced Recovery After Surgery Program Versus Conventional Care for Laparoscopic Common Bile Duct Exploration
A study testing ERAS and Conventional in people with Choledocholithiasis, run by South Valley University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- ERAS and Conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with CBDS
- American Society of Anesthesiologists (ASA) scores of I - II
- Age 20-70 years
Who cannot join
- Severe cholangitis
- Severe pancreatitis
- Mirizzi syndrome
- Perforated gallbladder
- Biliary peritonitis
- Intrahepatic stones
Show all 10Show fewer
- Hepatobiliary malignancy
- Pregnancy
- Conversion to open surgery
- Previous upper abdominal surgery
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
South Valley University
Luxor, 83523
South Valley University
Qina, 83523
About this study
Official title: Enhanced Recovery After Surgery Program Versus Conventional Care for Laparoscopic Common Bile Duct Exploration: A Randomized Controlled Trial
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
Read the detailed description
All patients undergoing surgery prefer to stay at the hospital for a shorter period and resume work as early as possible. The post-operative recovery and rehabilitation are influenced by numerous surgical factors such as inadequate pain management and postoperative complications, and non-surgical factors such as anxiety and stress, reduced physical activity, and unintended prolonged fasting due to improper scheduling.
Carefully planned perioperative care is approved to shorten the rehabilitation period and accelerate the recovery by preserving preoperative organ function, reducing the depth of intraoperative stress reaction, and minimizing postoperative complications, through many parameters such as emotional support, pharmacological prophylaxis, wound anesthesia, PONV prophylaxis, low-pressure pneumoperitoneum, and restricted use of surgical drains and infusions contributing to medical and economic benefit in healthcare. Two techniques are believed to improve post-operative recovery and rehabilitation; the first is the minimally invasive surgery and the second is the enhanced recovery after surgery (ERAS) program.
Laparoscopic common bile duct exploration (LCBDE) is one of the recent minimally invasive maneuvers to treat common bile duct stones (CBDS) that may be combined with laparoscopic cholecystectomy for gallbladder stones as a one-stage procedure with the advantage of minor trauma and bleeding, low postoperative complication and pain, quick recovery, and shorter hospital stay. On the contrary, It has various complications due to pneumoperitoneum and positioning including changes in cardiac output and blood pressure, decreased lung volumes, basal atelectasis, increased intrapulmonary shunting, raised airway pressures, acute postoperative pain, and postoperative nausea and vomiting (PONV).
Enhanced recovery after surgery (ERAS) programs are a recent combination of evidenced-based perioperative care approaches that work synergistically to improve recovery after surgery. The underlying mechanism of ERAS protocols is thought to be an attenuation of the peri-operative stress response and early gut function. The core elements of ERAS protocols are preoperative advice, optimization of diet, systematic analgesic and anesthetic regimes, and early mobilization. It facilitates early mobilization and nutrition by controlling pain and dyspepsia, therefore reducing the postoperative length of stay, and allowing patients to return to their usual lifestyle as promptly as possible.
Although ERAS programs have become more popular over the past decade and the Association of Surgeons of Great Britain and Ireland, and ERAS society guidelines have recommended 23 guidelines for different surgical fields, it remains controversial and conflicts with the traditional doctrine for surgery. It therefore has been slow to be implemented so far. Also, no ERAS program for LCBDE was offered till now. Therefore, this study aimed to compare the efficacy and safety of ERAS versus conventional care in LCBDE.
- Conditions
- Choledocholithiasis
- Being tested
- ERAS, Conventional
- Keywords
- enhanced recovery after surgery, laparoscopic common bile duct exploration
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASProcedure or surgery
Also called Enhanced recovery after surgery
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.
ConventionalProcedure or surgery
Conventional care for patients subjected for laparoscopic common bile duct exploration
| Study group | Role | What they receive |
|---|---|---|
| ERAS-LCBDE | Experimental | Patients subjected to enhanced recovery after surgery care for laparoscopic common bile duct exploration Receives: Procedure: ERAS |
| C-LCBDE | Active comparator | Patients subjected to conventional care for laparoscopic common bile duct exploration Receives: Procedure: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lenghth of hospital stay
The duration from the surgery to discharge
Measured: 1 - 30 days
Secondary outcomes (1)
Postoperative complications
the number of complications within 30 days postoperatively
Measured: 1 - 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Omar, MD, South Valley University
- Investigators
- Marwa N Alansary, Lecturer, Study director, South Valley UniversityMohammed A Omar, Professor, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630767
- Sponsor's protocol ID
- SVU/MED/SUR011/11/24/4/612
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Program Versus Conventional Care for Laparoscopic Common Bile Duct Exploration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06630767
- Acronym / sponsor ID
- SVU/MED/SUR011/11/24/4/612
- Conditions
- Choledocholithiasis
- Keywords
- enhanced recovery after surgery, laparoscopic common bile duct exploration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
All patients undergoing surgery prefer to stay at the hospital for a shorter period and resume work as early as possible. The post-operative recovery and rehabilitation are influenced by numerous surgical factors such as inadequate pain management and postoperative complications, and non-surgical factors such as anxiety and stress, reduced physical activity, and unintended prolonged fasting due to improper scheduling.
Carefully planned perioperative care is approved to shorten the rehabilitation period and accelerate the recovery by preserving preoperative organ function, reducing the depth of intraoperative stress reaction, and minimizing postoperative complications, through many parameters such as emotional support, pharmacological prophylaxis, wound anesthesia, PONV prophylaxis, low-pressure pneumoperitoneum, and restricted use of surgical drains and infusions contributing to medical and economic benefit in healthcare. Two techniques are believed to improve post-operative recovery and rehabilitation; the first is the minimally invasive surgery and the second is the enhanced recovery after surgery (ERAS) program.
Laparoscopic common bile duct exploration (LCBDE) is one of the recent minimally invasive maneuvers to treat common bile duct stones (CBDS) that may be combined with laparoscopic cholecystectomy for gallbladder stones as a one-stage procedure with the advantage of minor trauma and bleeding, low postoperative complication and pain, quick recovery, and shorter hospital stay. On the contrary, It has various complications due to pneumoperitoneum and positioning including changes in cardiac output and blood pressure, decreased lung volumes, basal atelectasis, increased intrapulmonary shunting, raised airway pressures, acute postoperative pain, and postoperative nausea and vomiting (PONV).
Enhanced recovery after surgery (ERAS) programs are a recent combination of evidenced-based perioperative care approaches that work synergistically to improve recovery after surgery. The underlying mechanism of ERAS protocols is thought to be an attenuation of the peri-operative stress response and early gut function. The core elements of ERAS protocols are preoperative advice, optimization of diet, systematic analgesic and anesthetic regimes, and early mobilization. It facilitates early mobilization and nutrition by controlling pain and dyspepsia, therefore reducing the postoperative length of stay, and allowing patients to return to their usual lifestyle as promptly as possible.
Although ERAS programs have become more popular over the past decade and the Association of Surgeons of Great Britain and Ireland, and ERAS society guidelines have recommended 23 guidelines for different surgical fields, it remains controversial and conflicts with the traditional doctrine for surgery. It therefore has been slow to be implemented so far. Also, no ERAS program for LCBDE was offered till now. Therefore, this study aimed to compare the efficacy and safety of ERAS versus conventional care in LCBDE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS-LCBDE | Experimental | Procedure: ERASPatients subjected to enhanced recovery after surgery care for laparoscopic common bile duct exploration |
| C-LCBDE | Active comparator | Procedure: ConventionalPatients subjected to conventional care for laparoscopic common bile duct exploration |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with CBDS
- American Society of Anesthesiologists (ASA) scores of I - II
- Age 20-70 years
Key exclusion criteria (10 listed)
- Severe cholangitis
- Severe pancreatitis
- Mirizzi syndrome
- Perforated gallbladder
- Biliary peritonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERASAlso: Enhanced recovery after surgeryEnhanced 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. | Procedure or surgery | ERAS-LCBDE |
| ConventionalConventional care for patients subjected for laparoscopic common bile duct exploration | Procedure or surgery | C-LCBDE |
Primary outcome
Lenghth of hospital stay
Time frame: 1 - 30 days
The duration from the surgery to discharge
1 secondary outcome
Postoperative complications
Time frame: 1 - 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Use of Enhanced Recovery After Surgery (ERAS) in Laparoscopic Cholecystectomy (LC) Combined with Laparoscopic Common Bile Duct Exploration (LCBDE): A Cohort StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa N Alansary, Lecturer study director
South Valley University
Mohammed A Omar, Professor principal investigator
South Valley University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS and Conventional in people with Choledocholithiasis, run by South Valley University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lenghth of hospital stay (time frame: 1 - 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.