Enhanced Recovery After SurgeryERASNCT05511194
Safety and Efficacy of ERAS Therapeutic Protocol for Complicated Appendicitis in Children
A study testing Enhanced Recovery After Surgery therapeutic protocol and Conventional management in people with Enhanced Recovery After Surgery and Appendicitis, run by Instituto Mexicano del Seguro Social.
Trial summary
Complicated appendicitis in pediatrics is frequent, potentially serious and complex to manage. The implementation of a ERAS model would allow optimizing perioperative care, offering a shorter hospital stay, reducing complications associated with medical care and costs, although adequate multidisciplinary management is… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Enhanced Recovery After Surgery, Appendicitis, Children, Only
- What is being tested?
- Enhanced Recovery After Surgery therapeutic protocol and Conventional management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Jan 2023
- 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 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between the ages of 1 and 17, who underwent surgery at the UMAE Hospital de Pediatría CMNO and who at the time of surgery are determined to be in a gangrenous or perforated phase.
Who cannot join
- Patients who, prior to surgery, present symptoms of intestinal obstruction, abdominal sepsis, or suffer from any underlying disease.
- Patients who require placement of a nasogastric tube or abdominal drainage during the intervention.
- Patients who were operated in another unit and enter the service for follow-up.
- Patients whose legal guardians do not agree to sign consent to participate in the protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Enhanced Recovery After Surgery Therapeutic Protocol for Complicated Appendicitis in Children
Complicated appendicitis in pediatrics is frequent, potentially serious and complex to manage. The implementation of a ERAS model would allow optimizing perioperative care, offering a shorter hospital stay, reducing complications associated with medical care and costs, although adequate multidisciplinary management is necessary. The objective of the study is to evaluate the safety and efficacy of the application of a ERAS therapeutic protocol and compare them with the safety and efficacy of conventional management in children with complicated appendicitis.
Read the detailed description
- All patients who meet the indicated criteria will be included, including signing an informed consent in the immediate postoperative period, and will be assigned to a control group or an experimental group based on simple random probabilistic sampling, using software (OxMaR: Oxford Minimization and Randomization, 2019) for minimization and randomization of clinical studies, single blind. A different postoperative treatment scheme will be applied for each of the groups.
- Post-surgical indications for each group: For both groups: assisted ambulation when recovering from the anesthetic effect, surgical wound care (daily bathing and cleaning the wound with soap and water, dressing change every 24 hours or as needed), preferably non-opioid analgesics. Experimental Group: scheduled nausea and vomiting prophylaxis the first postoperative 24 hours, start liquid diet 8 hours postoperative, if tolerated, advance to a soft diet in the next shift, double IV antibiotic scheme (ceftriaxone, metronidazole) for at least 3 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 3 days with IV antibiotic scheme, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever). Control Group: use of antiemetic only in case of nausea or vomiting, start of liquid diet when presenting intestinal transit data (channeling of gases or presence of evacuation), if they tolerate advancing to a soft diet in the next shift, triple IV antibiotic regimen (ampicillin, amikacin, metronidazole) for at least 5 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 5 days with IV antibiotic regimen, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever).
- The information on each case will be recorded on a data collection sheet, that will include an identification sheet (number of patient, telephone number, age and sex), date of admission, conditions at the time of admission, weight and height to calculate nutritional status, time of evolution in hours of the clinical picture until admission to the operating room, if he received antibiotic treatment prior to admission, post-surgical diagnosis (appendicitis phase), anesthetic method used, type of analgesic used, antibiotic scheme used, date of discharge and complications at discharge.
- Outpatient follow-up will be carried out with control at 7, 15 and 30 postoperative days, in person to identify the presence of complications through questioning and physical examination, as well as histopathological diagnosis review. These data will also be recorded on the collection sheet.
- Being tested
- Enhanced Recovery After Surgery therapeutic protocol, Conventional management
- Keywords
- Enhanced Recovery After Surgery, Appendicitis complicated, Appendectomy, Children, Perioperative period
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery therapeutic protocolOther
Feeding and early ambulation, double short IV antibiotic regimen.
Conventional managementOther
Delayed feeding and ambulation, triple short IV antibiotic regimen.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group: scheduled nausea and vomiting prophylaxis the first postoperative 24 hours, start liquid diet 8 hours postoperative, if tolerated, advance to a soft diet in the next shift, double IV antibiotic scheme (ceftriaxone, metronidazole) for at least 3 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 3 days with IV antibiotic scheme, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever). Receives: Other: Enhanced Recovery After Surgery therapeutic protocol |
| Control Group | Other | Control Group: use of antiemetic only in case of nausea or vomiting, start of liquid diet when presenting intestinal transit data (channeling of gases or presence of evacuation), if they tolerate advancing to a soft diet in the next shift, triple IV antibiotic regimen (ampicillin, amikacin, metronidazole) for at least 5 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 5 days with IV antibiotic regimen, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever). Receives: Other: Conventional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalary stay
Days elapsed between the admission of the patient for in-hospital management and his discharge by medical decision. Care effectiveness indicator.
Measured: 120 days
Complications
Adverse events presented as a consequence of the evolution of a disease or a medical intervention. Indicator of safety of the intervention carried out.
Measured: 120 days
Secondary outcomes (1)
Hospital costs
Costs based on unit costs by level of medical care (Official Gazette of the Federation).
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Enhanced Recovery After 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial, single blind.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social
- Investigators
- Gabriela Ambriz, MD, Study director, UMAE Pediatric Hospital CMNO IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511194
- Sponsor's protocol ID
- F-2022-1302-028
- Acronym
- ERAS
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not required
Publications
Omling E, Salo M, Saluja S, Bergbrant S, Olsson L, Persson A, Bjork J, Hagander L. Nationwide study of appendicitis in children. Br J Surg. 2019 Nov;106(12):1623-1631. doi: 10.1002/bjs.11298. Epub 2019 Aug 6.
PubMed 31386195Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. doi: 10.1093/oxfordjournals.aje.a115734.
PubMed 2239906Garst GC, Moore EE, Banerjee MN, Leopold DK, Burlew CC, Bensard DD, Biffl WL, Barnett CC, Johnson JL, Sauaia A. Acute appendicitis: a disease severity score for the acute care surgeon. J Trauma Acute Care Surg. 2013 Jan;74(1):32-6. doi: 10.1097/TA.0b013e318278934a.
PubMed 23271074Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.
PubMed 26460662Bonadio W, Rebillot K, Ukwuoma O, Saracino C, Iskhakov A. Management of Pediatric Perforated Appendicitis: Comparing Outcomes Using Early Appendectomy Versus Solely Medical Management. Pediatr Infect Dis J. 2017 Oct;36(10):937-941. doi: 10.1097/INF.0000000000001025.
PubMed 26669739Bolmers MD, van Rossem CC, Gorter RR, Bemelman WA, van Geloven AAW, Heij HA; Snapshot Appendicitis Collaborative Study group. Imaging in pediatric appendicitis is key to a low normal appendix percentage: a national audit on the outcome of appendectomy for appendicitis in children. Pediatr Surg Int. 2018 May;34(5):543-551. doi: 10.1007/s00383-018-4244-2. Epub 2018 Mar 9.
PubMed 29523946Fujishiro J, Watanabe E, Hirahara N, Terui K, Tomita H, Ishimaru T, Miyata H. Laparoscopic Versus Open Appendectomy for Acute Appendicitis in Children: a Nationwide Retrospective Study on Postoperative Outcomes. J Gastrointest Surg. 2021 Apr;25(4):1036-1044. doi: 10.1007/s11605-020-04544-3. Epub 2020 Mar 3.
PubMed 32128682Knaapen M, van Amstel P, van Amstel T, The SML, Bakx R, van Heurn ELWE, Gorter RR. Outcomes after appendectomy in children with acute appendicitis treated at a tertiary paediatric centre: results from a retrospective cohort study. Langenbecks Arch Surg. 2021 Feb;406(1):163-169. doi: 10.1007/s00423-020-01976-y. Epub 2020 Aug 28.
PubMed 32860108Martinez-Perez A, Paya-Llorente C, Santarrufina-Martinez S, Sebastian-Tomas JC, Martinez-Lopez E, de'Angelis N. Predictors for prolonged length of stay after laparoscopic appendectomy for complicated acute appendicitis in adults. Surg Endosc. 2021 Jul;35(7):3628-3635. doi: 10.1007/s00464-020-07841-9. Epub 2020 Aug 7.
PubMed 32767147Howell EC, Dubina ED, Lee SL. Perforation risk in pediatric appendicitis: assessment and management. Pediatric Health Med Ther. 2018 Oct 26;9:135-145. doi: 10.2147/PHMT.S155302. eCollection 2018.
PubMed 30464677Zavras N, Vaos G. Management of complicated acute appendicitis in children: Still an existing controversy. World J Gastrointest Surg. 2020 Apr 27;12(4):129-137. doi: 10.4240/wjgs.v12.i4.129.
PubMed 32426092Zani A, Hall NJ, Rahman A, Morini F, Pini Prato A, Friedmacher F, Koivusalo A, van Heurn E, Pierro A. European Paediatric Surgeons' Association Survey on the Management of Pediatric Appendicitis. Eur J Pediatr Surg. 2019 Feb;29(1):53-61. doi: 10.1055/s-0038-1668139. Epub 2018 Aug 15.
PubMed 30112745Yousef Y, Youssef F, Homsy M, Dinh T, Pandya K, Stagg H, Baird R, Laberge JM, Poenaru D, Puligandla P, Shaw K, Emil S. Standardization of care for pediatric perforated appendicitis improves outcomes. J Pediatr Surg. 2017 Dec;52(12):1916-1920. doi: 10.1016/j.jpedsurg.2017.08.054. Epub 2017 Sep 5.
PubMed 28935397Lam JY, Beaudry P, Simms BA, Brindle ME. Impact of implementing a fast-track protocol and standardized guideline for the management of pediatric appendicitis. Can J Surg. 2021 Jul 5;64(4):E364-E370. doi: 10.1503/cjs.005420.
PubMed 34223740Do-Wyeld M, Cundy TP, Court-Kowalski S, Dandie L, Cooper C, Burgoyne L, Cooksey R, Khurana S. Improving quality and efficiency of care for advanced appendicitis in children. ANZ J Surg. 2021 Jul;91(7-8):1497-1503. doi: 10.1111/ans.16929. Epub 2021 May 20.
PubMed 34013543
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Enhanced Recovery After Surgery Therapeutic Protocol for Complicated Appendicitis in Children
- ClinicalTrials.gov ID
- NCT05511194
- Acronym / sponsor ID
- ERAS / F-2022-1302-028
- Keywords
- Enhanced Recovery After Surgery, Appendicitis complicated, Appendectomy, Children, Perioperative period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 22 Aug 2022 (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.
Complicated appendicitis in pediatrics is frequent, potentially serious and complex to manage. The implementation of a ERAS model would allow optimizing perioperative care, offering a shorter hospital stay, reducing complications associated with medical care and costs, although adequate multidisciplinary management is necessary. The objective of the study is to evaluate the safety and efficacy of the application of a ERAS therapeutic protocol and compare them with the safety and efficacy of conventional management in children with complicated appendicitis.
Detailed description
- All patients who meet the indicated criteria will be included, including signing an informed consent in the immediate postoperative period, and will be assigned to a control group or an experimental group based on simple random probabilistic sampling, using software (OxMaR: Oxford Minimization and Randomization, 2019) for minimization and randomization of clinical studies, single blind. A different postoperative treatment scheme will be applied for each of the groups.
- Post-surgical indications for each group: For both groups: assisted ambulation when recovering from the anesthetic effect, surgical wound care (daily bathing and cleaning the wound with soap and water, dressing change every 24 hours or as needed), preferably non-opioid analgesics. Experimental Group: scheduled nausea and vomiting prophylaxis the first postoperative 24 hours, start liquid diet 8 hours postoperative, if tolerated, advance to a soft diet in the next shift, double IV antibiotic scheme (ceftriaxone, metronidazole) for at least 3 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 3 days with IV antibiotic scheme, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever). Control Group: use of antiemetic only in case of nausea or vomiting, start of liquid diet when presenting intestinal transit data (channeling of gases or presence of evacuation), if they tolerate advancing to a soft diet in the next shift, triple IV antibiotic regimen (ampicillin, amikacin, metronidazole) for at least 5 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 5 days with IV antibiotic regimen, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever).
- The information on each case will be recorded on a data collection sheet, that will include an identification sheet (number of patient, telephone number, age and sex), date of admission, conditions at the time of admission, weight and height to calculate nutritional status, time of evolution in hours of the clinical picture until admission to the operating room, if he received antibiotic treatment prior to admission, post-surgical diagnosis (appendicitis phase), anesthetic method used, type of analgesic used, antibiotic scheme used, date of discharge and complications at discharge.
- Outpatient follow-up will be carried out with control at 7, 15 and 30 postoperative days, in person to identify the presence of complications through questioning and physical examination, as well as histopathological diagnosis review. These data will also be recorded on the collection sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial, single blind.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Enhanced Recovery After Surgery therapeutic protocolExperimental Group: scheduled nausea and vomiting prophylaxis the first postoperative 24 hours, start liquid diet 8 hours postoperative, if tolerated, advance to a soft diet in the next shift, double IV antibiotic scheme (ceftriaxone, metronidazole) for at least 3 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 3 days with IV antibiotic scheme, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever). |
| Control Group | Other | Other: Conventional managementControl Group: use of antiemetic only in case of nausea or vomiting, start of liquid diet when presenting intestinal transit data (channeling of gases or presence of evacuation), if they tolerate advancing to a soft diet in the next shift, triple IV antibiotic regimen (ampicillin, amikacin, metronidazole) for at least 5 days and change to oral route upon discharge to complete 10 days of antibiotics, discharge upon accomplish discharge criteria (at least 5 days with IV antibiotic regimen, tolerance to feeding, tolerance to postoperative pain and 24 hours without the presence of fever). |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients between the ages of 1 and 17, who underwent surgery at the UMAE Hospital de Pediatría CMNO and who at the time of surgery are determined to be in a gangrenous or perforated phase.
Key exclusion criteria (4 listed)
- Patients who, prior to surgery, present symptoms of intestinal obstruction, abdominal sepsis, or suffer from any underlying disease.
- Patients who require placement of a nasogastric tube or abdominal drainage during the intervention.
- Patients who were operated in another unit and enter the service for follow-up.
- Patients whose legal guardians do not agree to sign consent to participate in the protocol.
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 |
|---|---|---|
| Enhanced Recovery After Surgery therapeutic protocolFeeding and early ambulation, double short IV antibiotic regimen. | Other | Experimental Group |
| Conventional managementDelayed feeding and ambulation, triple short IV antibiotic regimen. | Other | Control Group |
Primary outcome
Hospitalary stay
Time frame: 120 days
Days elapsed between the admission of the patient for in-hospital management and his discharge by medical decision. Care effectiveness indicator.
Complications
Time frame: 120 days
Adverse events presented as a consequence of the evolution of a disease or a medical intervention. Indicator of safety of the intervention carried out.
1 secondary outcome
Hospital costs
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Results publication: PubMed 31386195Omling E, Salo M, Saluja S, Bergbrant S, Olsson L, Persson A, Bjork J, Hagander L. Nationwide study of appendicitis in children. Br J Surg. 2019 Nov;106(12):1623-1631. doi: 10.1002/bjs.11298. Epub 2019 Aug 6.
- Results publication: PubMed 2239906Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. doi: 10.1093/oxfordjournals.aje.a115734.
- Results publication: PubMed 23271074Garst GC, Moore EE, Banerjee MN, Leopold DK, Burlew CC, Bensard DD, Biffl WL, Barnett CC, Johnson JL, Sauaia A. Acute appendicitis: a disease severity score for the acute care surgeon. J Trauma Acute Care Surg. 2013 Jan;74(1):32-6. doi: 10.1097/TA.0b013e318278934a.
- Results publication: PubMed 26460662Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.
- Results publication: PubMed 26669739Bonadio W, Rebillot K, Ukwuoma O, Saracino C, Iskhakov A. Management of Pediatric Perforated Appendicitis: Comparing Outcomes Using Early Appendectomy Versus Solely Medical Management. Pediatr Infect Dis J. 2017 Oct;36(10):937-941. doi: 10.1097/INF.0000000000001025.
- Results publication: PubMed 29523946Bolmers MD, van Rossem CC, Gorter RR, Bemelman WA, van Geloven AAW, Heij HA; Snapshot Appendicitis Collaborative Study group. Imaging in pediatric appendicitis is key to a low normal appendix percentage: a national audit on the outcome of appendectomy for appendicitis in children. Pediatr Surg Int. 2018 May;34(5):543-551. doi: 10.1007/s00383-018-4244-2. Epub 2018 Mar 9.
- Results publication: PubMed 32128682Fujishiro J, Watanabe E, Hirahara N, Terui K, Tomita H, Ishimaru T, Miyata H. Laparoscopic Versus Open Appendectomy for Acute Appendicitis in Children: a Nationwide Retrospective Study on Postoperative Outcomes. J Gastrointest Surg. 2021 Apr;25(4):1036-1044. doi: 10.1007/s11605-020-04544-3. Epub 2020 Mar 3.
- Results publication: PubMed 32860108Knaapen M, van Amstel P, van Amstel T, The SML, Bakx R, van Heurn ELWE, Gorter RR. Outcomes after appendectomy in children with acute appendicitis treated at a tertiary paediatric centre: results from a retrospective cohort study. Langenbecks Arch Surg. 2021 Feb;406(1):163-169. doi: 10.1007/s00423-020-01976-y. Epub 2020 Aug 28.
- Results publication: PubMed 32767147Martinez-Perez A, Paya-Llorente C, Santarrufina-Martinez S, Sebastian-Tomas JC, Martinez-Lopez E, de'Angelis N. Predictors for prolonged length of stay after laparoscopic appendectomy for complicated acute appendicitis in adults. Surg Endosc. 2021 Jul;35(7):3628-3635. doi: 10.1007/s00464-020-07841-9. Epub 2020 Aug 7.
- Results publication: PubMed 30464677Howell EC, Dubina ED, Lee SL. Perforation risk in pediatric appendicitis: assessment and management. Pediatric Health Med Ther. 2018 Oct 26;9:135-145. doi: 10.2147/PHMT.S155302. eCollection 2018.
- Results publication: PubMed 32426092Zavras N, Vaos G. Management of complicated acute appendicitis in children: Still an existing controversy. World J Gastrointest Surg. 2020 Apr 27;12(4):129-137. doi: 10.4240/wjgs.v12.i4.129.
- Results publication: PubMed 30112745Zani A, Hall NJ, Rahman A, Morini F, Pini Prato A, Friedmacher F, Koivusalo A, van Heurn E, Pierro A. European Paediatric Surgeons' Association Survey on the Management of Pediatric Appendicitis. Eur J Pediatr Surg. 2019 Feb;29(1):53-61. doi: 10.1055/s-0038-1668139. Epub 2018 Aug 15.
- 17\. Malaekah H, Makhdoom F, Almedbal H and Aggarwal R. Acute Appendicitis Pathways: A Systemic Review. Surgical Science, 2021; 12: 143-159.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not required
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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.
Gabriela Ambriz, MD study director
UMAE Pediatric Hospital CMNO IMSS
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery therapeutic protocol and Conventional management in people with Enhanced Recovery After Surgery and Appendicitis, run by Instituto Mexicano del Seguro Social.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Calderón, MD (6673152519, anabe_calderon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalary stay (time frame: 120 days). The study lists 2 primary outcomes in all. 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 NCT05511194, which also lists 34 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 22 Aug 2022.