Acute CholecystitisERLACNCT03754751
Enhanced Recovery in Laparoscopic Cholecystectomy
A study testing Laparoscopic cholecystectomy with the implementation of modified ERAS program and Laparoscopic cholecystectomy with standard perioperative treatment in people with Acute Cholecystitis and Gangrenous Cholecystitis, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis, Gangrenous Cholecystitis
- What is being tested?
- Laparoscopic cholecystectomy with the implementation of modified ERAS program and Laparoscopic cholecystectomy with standard perioperative treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteRussia
- Study dates
- 31 Jan 2017to 30 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)
- ASA I and II.
Who cannot join
- Severe acute cholecystitis (Grade III on TG13);
- Patient's refusal to participate;
- The language barrier;
- Transfer to the intensive care unit after surgery;
- ASA class ≥ III;
- Conversion to open procedure;
- Biliary hypertension detected during preoperative examination or intraoperatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.
Read the detailed description
Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world. Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation period are often associated with severe pain syndrome, dyspepsia and postoperative complications. The complications rate after LC is about 6% and has no tendency to decrease. The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce stress-associated complications and improve the quality of rehabilitation. A few retrospective studies examined their advantages and setbacks in the treatment of acute cholecystitis with encouraging results. The aim of this randomized control study is to evaluate the modified ERAS program for patients with acute cholecystitis.
- Conditions
- Acute Cholecystitis, Gangrenous Cholecystitis
- Being tested
- Laparoscopic cholecystectomy with the implementation of modified ERAS program, Laparoscopic cholecystectomy with standard perioperative treatment
- Keywords
- enhanced recovery, intraperitoneal anesthesia, low pressure pneumoperitoneum, cholecystitis, in-hospital stay, laparoscopic cholecystectomy
- Medical subject headings
- Cholecystitis, Acute, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomy with the implementation of modified ERAS programProcedure or surgery
Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.
- Patient informing and brochure
Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia
- Low-pressure pneumoperitoneum (8-9 mmHg)
- Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine
- PONV prophylaxis in patients of risk
Postoperative care
- Early mobilization (2 h after surgery)
- Early fluid intake (2 h after surgery)
- Early liquid food (6 h after surgery) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery
Laparoscopic cholecystectomy with standard perioperative treatmentProcedure or surgery
Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.
- Patient oral informing. No brochure
Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia
- Standard CO2 pressure (12-14 mmHg)
- No additional anesthesia
Postoperative care
- Mobilization in 4-6 h after surgery
- Fluid intake in 6 hours
- Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery
| Study group | Role | What they receive |
|---|---|---|
| Modified ERAS program group | Experimental | Laparoscopic cholecystectomy with the implementation of modified ERAS program Receives: Procedure: Laparoscopic cholecystectomy with the implementation of modified ERAS program |
| Conventional care group | Active comparator | Laparoscopic cholecystectomy with standard perioperative treatment Receives: Procedure: Laparoscopic cholecystectomy with standard perioperative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of stay (pLOS)
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
Measured: 30 days
Secondary outcomes (5)
Complication rate
Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage
Measured: 30 days
Readmission rate
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
Measured: 30 days
Postoperative pain
Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Measured: 24 hours
Shoulder pain incidence
Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
Measured: 24 hours
Shoulder pain level
Level of shoulder pain syndrome measured with a visual analog scale in centimeters
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start31 Jan 2017
- Primary completion1 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies 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
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Sazhin, Prof., Study chair, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754751
- Sponsor's protocol ID
- ERLAC
- Acronym
- ERLAC
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03754751
- Acronym / sponsor ID
- ERLAC / ERLAC
- Conditions
- Acute Cholecystitis, Gangrenous Cholecystitis
- Keywords
- enhanced recovery, intraperitoneal anesthesia, low pressure pneumoperitoneum, cholecystitis, in-hospital stay, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 27 Nov 2018 (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.
The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.
Detailed description
Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world. Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation period are often associated with severe pain syndrome, dyspepsia and postoperative complications. The complications rate after LC is about 6% and has no tendency to decrease. The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce stress-associated complications and improve the quality of rehabilitation. A few retrospective studies examined their advantages and setbacks in the treatment of acute cholecystitis with encouraging results. The aim of this randomized control study is to evaluate the modified ERAS program for patients with acute cholecystitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ERAS program group | Experimental | Procedure: Laparoscopic cholecystectomy with the implementation of modified ERAS programLaparoscopic cholecystectomy with the implementation of modified ERAS program |
| Conventional care group | Active comparator | Procedure: Laparoscopic cholecystectomy with standard perioperative treatmentLaparoscopic cholecystectomy with standard perioperative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)
- ASA I and II.
Key exclusion criteria (7 listed)
- Severe acute cholecystitis (Grade III on TG13);
- Patient's refusal to participate;
- The language barrier;
- Transfer to the intensive care unit after surgery;
- ASA class ≥ III;
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 |
|---|---|---|
| Laparoscopic cholecystectomy with the implementation of modified ERAS programPreoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery. 1) Patient informing and brochure Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia 1. Low-pressure pneumoperitoneum (8-9 mmHg) 2. Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine 3. PONV prophylaxis in patients of risk Postoperative care 1. Early mobilization (2 h after surgery) 2. Early fluid intake (2 h after surgery) 3. Early liquid food (6 h after surgery) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery | Procedure or surgery | Modified ERAS program group |
| Laparoscopic cholecystectomy with standard perioperative treatmentPreoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery. 1) Patient oral informing. No brochure Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia 1. Standard CO2 pressure (12-14 mmHg) 2. No additional anesthesia Postoperative care 1. Mobilization in 4-6 h after surgery 2. Fluid intake in 6 hours 3. Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery | Procedure or surgery | Conventional care group |
Primary outcome
Postoperative length of stay (pLOS)
Time frame: 30 days
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
5 secondary outcomes
Complication rate
Time frame: 30 days
Readmission rate
Time frame: 30 days
Postoperative pain
Time frame: 24 hours
Shoulder pain incidence
Time frame: 24 hours
Shoulder pain level
Time frame: 24 hours
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 Jan 2021.
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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.
Alexander Sazhin, Prof. study chair
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy with the implementation of modified ERAS program and Laparoscopic cholecystectomy with standard perioperative treatment in people with Acute Cholecystitis and Gangrenous Cholecystitis, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 2 inclusion and 7 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Postoperative length of stay (pLOS) (time frame: 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 Jan 2021.