SurgeryNCT06981572
Comparing the Effectiveness of Modified ERAS Protocols vs. Standard Management in Pediatric Gastrointestinal Surgery
A study testing Modified Enhanced Recovery After Surgery Protocol in people with Surgery and Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Perioperative management of pediatric patients with gastrointestinal diseases involves a fairly length process and which can lead to rapid deterioration even death. Preoperative management includes preoperative fasting for such a long time, usage of drains and tubes and post-operative bed rest for a long time which… Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Surgery, Anesthesia
- What is being tested?
- Modified Enhanced Recovery After Surgery Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2024to 31 Mar 2025
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 1 month to 2 years
- The patient underwent major gastrointestinal surgery
- ASA 1 and 2 physical status
- The patient will undergo elective lower abdominal surgery with general and regional anesthesia
Who cannot join
- Patients with cyanotic congenital heart defects
- Patients with metabolic disorders
- Patients with decreased consciousness
- Patients with severe cognitive impairment
- Patients with relaparotomy due to surgical complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Implementing Modified ERAS Protocols vs. Standard Management in Pediatric Patients Undergoing Major Gastrointestinal Surgery
Perioperative management of pediatric patients with gastrointestinal diseases involves a fairly length process and which can lead to rapid deterioration even death. Preoperative management includes preoperative fasting for such a long time, usage of drains and tubes and post-operative bed rest for a long time which can cause pain, stress, and slowing down the recovery time for normal bowel function, thus further prolonging the patient's stay in hospital. Enhanced recovery after surgery (ERAS) is a concept that seeks faster recovery times for pediatric patients and shortens the length of hospital stay while still improving postoperative outcomes. The ERAS modification protocol aims to optimize inpatient care and minimize patient discomfort. Studies show that implementing the modified ERAS protocol can reduce the duration of hospitalization and the incidence of postoperative complications as well as speedy recovery. However, currently the standard ERAS protocol is difficult to apply to pediatric patients. This study will determine the comparison of the effectiveness of the ERAS modification protocol with the standard protocol in reducing length of stay and improving postoperative outcomes for pediatric patients at RSCM who underwent major gastrointestinal surgery using the ERAS modification method.
Read the detailed description
Perioperative management of pediatric patients with gastrointestinal diseases involves a fairly length process and which can lead to rapid deterioration even death. Preoperative management includes preoperative fasting for such a long time, usage of drains and tubes and post-operative bed rest for a long time which can cause pain, stress, and slowing down the recovery time for normal bowel function, thus further prolonging the patient's stay in hospital. Enhanced recovery after surgery (ERAS) is a concept that seeks faster recovery times for pediatric patients and shortens the length of hospital stay while still improving postoperative outcomes. ERAS was first introduced by a Danish surgeon, Henrik Kehlet in the 1990s to reduce perioperative stress and organ dysfunction in surgical patients. ERAS is an evidence-based technique and combines and optimizes various multidisciplinary methods used in conventional surgical management, includes surgery, anesthesia, nursing, and nutrition. ERAS emphasizes perioperative preparation including preoperative counseling, limited time in preoperative fasting, optimal anesthesia, minimally invasive techniques, immediate postoperative oral nutrition and mobilization, and non-routine use of drainage and surgical tubes. The ERAS modification protocol aims to optimize inpatient care and minimize patient discomfort. Studies show that implementing the modified ERAS protocol can reduce the duration of hospitalization and the incidence of postoperative complications as well as speedy recovery. However, currently the standard ERAS protocol is difficult to apply to pediatric patients because several conditions are not possible in pediatric patients, for example, administering anticoagulants, post-operative fasting, etc., thus requiring modifications that are tailored to the characteristics of the patients at Ciptomangunkusumo Hospital. Children experience a more complex surgical stress response than adult patients. Conventional perioperative management in children often results in greater physical stress. Therefore, perioperative management in children needs to be optimized.
- Conditions
- Surgery, Anesthesia
- Being tested
- Modified Enhanced Recovery After Surgery Protocol
- Keywords
- enhanced recovery after surgery, major intestinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Enhanced Recovery After Surgery ProtocolProcedure or surgery
This study is to determine the comparison of the effectiveness of the ERAS modification protocol with the standard protocol in reducing length of stay and improving postoperative outcomes for pediatric patients at RSCM who underwent major gastrointestinal surgery using the ERAS modification method. This study is a single-blind clinical trial. Research subjects will be randomly divided into two groups, namely the group who underwent surgery with the ERAS modification protocol and the group who underwent surgery without the ERAS modification protocol. Modified ERAS protocol will be applied during perioperative
| Study group | Role | What they receive |
|---|---|---|
| modified ERAS protocol applied | Active comparator | patients modified ERAS protocol applied Receives: Procedure: Modified Enhanced Recovery After Surgery Protocol |
| standart protocol applied | No intervention | patients with standart protocol applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Patients' length of stay in the hospital, measured in days
Measured: The timeframe is calculated from when the patient undergoes preoperative assessment until discharge from the hospital, up to 3 months.
Secondary outcomes (4)
Blood glucose level (mg/dL)
Blood glucose levels measured and compared during the preoperative, intraoperative, and postoperative periods
Measured: The time frame includes 1 day before surgery (preoperative), during surgery (intraoperative), and on the 3rd and 5th days after surgery (postoperative)
Blood electrolyte levels (Na, K, Cl)
Blood electrolyte levels assessed during the preoperative and postoperative periods
Measured: Blood electrolyte levels assessed 1 day before surgery (preoperative) and on the 3rd day after surgery (postoperative)
Oral Nutrition Initiation Time
The time when the patient begins receiving oral nutrition, starting with clear fluids. Oral nutrition initiation time will be measured in hours
Measured: The time frame is calculated from the end of the surgery and will be evaluated up to the time of the patient's discharge from the hospital
Time to mobilization
The time when the patient begins mobilization, which includes turning to the right and left sides, sitting, walking, and eventually resuming preoperative activities without pain or discomfort. The mobilization time is measured in days
Measured: The time frame is calculated from the end of surgery and will be evaluated up to the time of the patient's discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Mar 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andi Ade Wijaya Ramlan, Universitas Indonesia
- Investigators
- Andi Ade Wijaya Ramlan, Study chair, Anesthesiology and Intensive Therapy Departement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981572
- Sponsor's protocol ID
- IndonesiaUAnes2809
- Status last verified
- May 2025
- First submitted
- 28 Mar 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brindle ME, Heiss K, Scott MJ, Herndon CA, Ljungqvist O, Koyle MA; on behalf Pediatric ERAS (Enhanced Recovery After Surgery) Society. Embracing change: the era for pediatric ERAS is here. Pediatr Surg Int. 2019 Jun;35(6):631-634. doi: 10.1007/s00383-019-04476-3. Epub 2019 Apr 25.
PubMed 31025092Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PubMed 21712716Garin C. Enhanced recovery after surgery in pediatric orthopedics (ERAS-PO). Orthop Traumatol Surg Res. 2020 Feb;106(1S):S101-S107. doi: 10.1016/j.otsr.2019.05.012. Epub 2019 Sep 12.
PubMed 31522902Ceelie I, de Wildt SN, van Dijk M, van den Berg MM, van den Bosch GE, Duivenvoorden HJ, de Leeuw TG, Mathot R, Knibbe CA, Tibboel D. Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial. JAMA. 2013 Jan 9;309(2):149-54. doi: 10.1001/jama.2012.148050.
PubMed 23299606Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.
PubMed 25501695Somri M, Matter I, Parisinos CA, Shaoul R, Mogilner JG, Bader D, Asphandiarov E, Gaitini LA. The effect of combined spinal-epidural anesthesia versus general anesthesia on the recovery time of intestinal function in young infants undergoing intestinal surgery: a randomized, prospective, controlled trial. J Clin Anesth. 2012 Sep;24(6):439-45. doi: 10.1016/j.jclinane.2012.02.004. Epub 2012 Jul 2.
PubMed 22762977Narvey MR, Marks SD. The screening and management of newborns at risk for low blood glucose. Paediatr Child Health. 2019 Dec;24(8):536-554. doi: 10.1093/pch/pxz134. Epub 2019 Dec 9.
PubMed 31844395Gao R, Yang H, Li Y, Meng L, Li Y, Sun B, Zhang G, Yue M, Guo F. Enhanced recovery after surgery in pediatric gastrointestinal surgery. J Int Med Res. 2019 Oct;47(10):4815-4826. doi: 10.1177/0300060519865350. Epub 2019 Aug 4.
PubMed 31379230George JA, Salazar AJG, Irfan A, Prichett L, Nasr IW, Garcia AV, Boss EF, Jelin EB. Effect of implementing an enhanced recovery protocol for pediatric colorectal surgery on complication rate, length of stay, and opioid use in children. J Pediatr Surg. 2022 Jul;57(7):1349-1353. doi: 10.1016/j.jpedsurg.2022.01.004. Epub 2022 Jan 15.
PubMed 35153077Phillips MR, Adamson WT, McLean SE, Hance L, Lupa MC, Pittenger SL, Dave P, McNaull PP. Implementation of a pediatric enhanced recovery pathway decreases opioid utilization and shortens time to full feeding. J Pediatr Surg. 2020 Jan;55(1):101-105. doi: 10.1016/j.jpedsurg.2019.09.065. Epub 2019 Nov 15.
PubMed 31784102Loganathan AK, Joselyn AS, Babu M, Jehangir S. Implementation and outcomes of enhanced recovery protocols in pediatric surgery: a systematic review and meta-analysis. Pediatr Surg Int. 2022 Jan;38(1):157-168. doi: 10.1007/s00383-021-05008-8. Epub 2021 Sep 15.
PubMed 34524519
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Implementing Modified ERAS Protocols vs. Standard Management in Pediatric Patients Undergoing Major Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT06981572
- Acronym / sponsor ID
- IndonesiaUAnes2809
- Conditions
- Surgery, Anesthesia
- Keywords
- enhanced recovery after surgery, major intestinal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 20 May 2025 (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.
Perioperative management of pediatric patients with gastrointestinal diseases involves a fairly length process and which can lead to rapid deterioration even death. Preoperative management includes preoperative fasting for such a long time, usage of drains and tubes and post-operative bed rest for a long time which can cause pain, stress, and slowing down the recovery time for normal bowel function, thus further prolonging the patient's stay in hospital. Enhanced recovery after surgery (ERAS) is a concept that seeks faster recovery times for pediatric patients and shortens the length of hospital stay while still improving postoperative outcomes. The ERAS modification protocol aims to optimize inpatient care and minimize patient discomfort. Studies show that implementing the modified ERAS protocol can reduce the duration of hospitalization and the incidence of postoperative complications as well as speedy recovery. However, currently the standard ERAS protocol is difficult to apply to pediatric patients. This study will determine the comparison of the effectiveness of the ERAS modification protocol with the standard protocol in reducing length of stay and improving postoperative outcomes for pediatric patients at RSCM who underwent major gastrointestinal surgery using the ERAS modification method.
Detailed description
Perioperative management of pediatric patients with gastrointestinal diseases involves a fairly length process and which can lead to rapid deterioration even death. Preoperative management includes preoperative fasting for such a long time, usage of drains and tubes and post-operative bed rest for a long time which can cause pain, stress, and slowing down the recovery time for normal bowel function, thus further prolonging the patient's stay in hospital. Enhanced recovery after surgery (ERAS) is a concept that seeks faster recovery times for pediatric patients and shortens the length of hospital stay while still improving postoperative outcomes. ERAS was first introduced by a Danish surgeon, Henrik Kehlet in the 1990s to reduce perioperative stress and organ dysfunction in surgical patients. ERAS is an evidence-based technique and combines and optimizes various multidisciplinary methods used in conventional surgical management, includes surgery, anesthesia, nursing, and nutrition. ERAS emphasizes perioperative preparation including preoperative counseling, limited time in preoperative fasting, optimal anesthesia, minimally invasive techniques, immediate postoperative oral nutrition and mobilization, and non-routine use of drainage and surgical tubes. The ERAS modification protocol aims to optimize inpatient care and minimize patient discomfort. Studies show that implementing the modified ERAS protocol can reduce the duration of hospitalization and the incidence of postoperative complications as well as speedy recovery. However, currently the standard ERAS protocol is difficult to apply to pediatric patients because several conditions are not possible in pediatric patients, for example, administering anticoagulants, post-operative fasting, etc., thus requiring modifications that are tailored to the characteristics of the patients at Ciptomangunkusumo Hospital. Children experience a more complex surgical stress response than adult patients. Conventional perioperative management in children often results in greater physical stress. Therefore, perioperative management in children needs to be optimized.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified ERAS protocol applied | Active comparator | Procedure: Modified Enhanced Recovery After Surgery Protocolpatients modified ERAS protocol applied |
| standart protocol applied | No intervention | –patients with standart protocol applied |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients aged 1 month to 2 years
- The patient underwent major gastrointestinal surgery
- ASA 1 and 2 physical status
- The patient will undergo elective lower abdominal surgery with general and regional anesthesia
Key exclusion criteria (5 listed)
- Patients with cyanotic congenital heart defects
- Patients with metabolic disorders
- Patients with decreased consciousness
- Patients with severe cognitive impairment
- Patients with relaparotomy due to surgical complications
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 |
|---|---|---|
| Modified Enhanced Recovery After Surgery ProtocolThis study is to determine the comparison of the effectiveness of the ERAS modification protocol with the standard protocol in reducing length of stay and improving postoperative outcomes for pediatric patients at RSCM who underwent major gastrointestinal surgery using the ERAS modification method. This study is a single-blind clinical trial. Research subjects will be randomly divided into two groups, namely the group who underwent surgery with the ERAS modification protocol and the group who underwent surgery without the ERAS modification protocol. Modified ERAS protocol will be applied during perioperative | Procedure or surgery | modified ERAS protocol applied |
Primary outcome
Length of stay
Time frame: The timeframe is calculated from when the patient undergoes preoperative assessment until discharge from the hospital, up to 3 months.
Patients' length of stay in the hospital, measured in days
4 secondary outcomes
Blood glucose level (mg/dL)
Time frame: The time frame includes 1 day before surgery (preoperative), during surgery (intraoperative), and on the 3rd and 5th days after surgery (postoperative)
Blood electrolyte levels (Na, K, Cl)
Time frame: Blood electrolyte levels assessed 1 day before surgery (preoperative) and on the 3rd day after surgery (postoperative)
Oral Nutrition Initiation Time
Time frame: The time frame is calculated from the end of the surgery and will be evaluated up to the time of the patient's discharge from the hospital
Time to mobilization
Time frame: The time frame is calculated from the end of surgery and will be evaluated up to the time of the patient's discharge from the hospital
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 20 May 2025.
- Background: PubMed 31025092Brindle ME, Heiss K, Scott MJ, Herndon CA, Ljungqvist O, Koyle MA; on behalf Pediatric ERAS (Enhanced Recovery After Surgery) Society. Embracing change: the era for pediatric ERAS is here. Pediatr Surg Int. 2019 Jun;35(6):631-634. doi: 10.1007/s00383-019-04476-3. Epub 2019 Apr 25.
- Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Background: PubMed 21712716Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Background: PubMed 31522902Garin C. Enhanced recovery after surgery in pediatric orthopedics (ERAS-PO). Orthop Traumatol Surg Res. 2020 Feb;106(1S):S101-S107. doi: 10.1016/j.otsr.2019.05.012. Epub 2019 Sep 12.
- Background: PubMed 23299606Ceelie I, de Wildt SN, van Dijk M, van den Berg MM, van den Bosch GE, Duivenvoorden HJ, de Leeuw TG, Mathot R, Knibbe CA, Tibboel D. Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial. JAMA. 2013 Jan 9;309(2):149-54. doi: 10.1001/jama.2012.148050.
- Background: PubMed 25501695Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.
- Background: PubMed 22762977Somri M, Matter I, Parisinos CA, Shaoul R, Mogilner JG, Bader D, Asphandiarov E, Gaitini LA. The effect of combined spinal-epidural anesthesia versus general anesthesia on the recovery time of intestinal function in young infants undergoing intestinal surgery: a randomized, prospective, controlled trial. J Clin Anesth. 2012 Sep;24(6):439-45. doi: 10.1016/j.jclinane.2012.02.004. Epub 2012 Jul 2.
- Background: PubMed 31844395Narvey MR, Marks SD. The screening and management of newborns at risk for low blood glucose. Paediatr Child Health. 2019 Dec;24(8):536-554. doi: 10.1093/pch/pxz134. Epub 2019 Dec 9.
- Background: PubMed 31379230Gao R, Yang H, Li Y, Meng L, Li Y, Sun B, Zhang G, Yue M, Guo F. Enhanced recovery after surgery in pediatric gastrointestinal surgery. J Int Med Res. 2019 Oct;47(10):4815-4826. doi: 10.1177/0300060519865350. Epub 2019 Aug 4.
- Background: PubMed 35153077George JA, Salazar AJG, Irfan A, Prichett L, Nasr IW, Garcia AV, Boss EF, Jelin EB. Effect of implementing an enhanced recovery protocol for pediatric colorectal surgery on complication rate, length of stay, and opioid use in children. J Pediatr Surg. 2022 Jul;57(7):1349-1353. doi: 10.1016/j.jpedsurg.2022.01.004. Epub 2022 Jan 15.
- Background: PubMed 31784102Phillips MR, Adamson WT, McLean SE, Hance L, Lupa MC, Pittenger SL, Dave P, McNaull PP. Implementation of a pediatric enhanced recovery pathway decreases opioid utilization and shortens time to full feeding. J Pediatr Surg. 2020 Jan;55(1):101-105. doi: 10.1016/j.jpedsurg.2019.09.065. Epub 2019 Nov 15.
- Background: PubMed 34524519Loganathan AK, Joselyn AS, Babu M, Jehangir S. Implementation and outcomes of enhanced recovery protocols in pediatric surgery: a systematic review and meta-analysis. Pediatr Surg Int. 2022 Jan;38(1):157-168. doi: 10.1007/s00383-021-05008-8. Epub 2021 Sep 15.
- 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.
Andi Ade Wijaya Ramlan study chair
Anesthesiology and Intensive Therapy Departement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Enhanced Recovery After Surgery Protocol in people with Surgery and Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 5 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 20 May 2025. 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 Indonesia. 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?
Length of stay (time frame: The timeframe is calculated from when the patient undergoes preoperative assessment until discharge from the hospital, up to 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981572, which also lists 12 linked publications.
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 20 May 2025.