Major SurgerySURGCOMNCT07621198
Postoperative Complications in Major Surgery
An observational study of Major Surgery, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
Trial summary
The primary objective of this study is to develop and validate a multivariable risk prediction model for 30-day major postoperative complications and mortality in patients undergoing major surgery across participating international centers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Surgery
- What is being tested?
- Patients with postoperative complications
- How many people
- 364 participants
- Where
- 1 siteColombia
- Study dates
- 1 Aug 2026to 30 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients included in the study are those with a major operative procedure during a window opportunity of 7 days.
Who may be able to join
- Major surgery
- Adult or pediatric patients
- Emergency or elective surgery
- Ambulatory or hospitalized patients
Who cannot join
- Patients derived to other institution
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Hospital Departamental de Villavicencio
Villavicencio, Meta Department, 50001
Norton Perez-Gutiérrez, MD, 3112517471, norton.perez@hotmail.com
Emma I Rodriguez-Darabos, MSc, 3112517538, emmaisa1@hotmail.com
About this study
Official title: Prediction of Postoperative Complications in Major Surgery: A Prospective, Multicenter, Cohort Study in Low- and Middle-income Settings
The primary objective of this study is to develop and validate a multivariable risk prediction model for 30-day major postoperative complications and mortality in patients undergoing major surgery across participating international centers. Despite advancements in perioperative care, surgical complications remain a leading cause of global morbidity and preventable death, particularly in resource-limited or low- and middle-income country (LMIC) settings.
This study utilizes a prospective, multicenter, international cohort design. Data will be collected on patient-level risk factors (e.g., age, frailty, comorbidities), hospital-level infrastructure (e.g., nurse-to-patient ratios, rescue capacity), and perioperative safety processes (e.g., adherence to the WHO Surgical Safety Checklist). Patients will be followed prospectively for up to 30 days post-surgery. The collected data will be used to construct robust predictive models to identify individual patient risk and uncover actionable system-level factors to optimize surgical safety globally.
Read the detailed description
Background and Rationale: Postoperative complications impose a substantial clinical and economic burden worldwide. While extensive research has focused on patient-derived clinical risks, fewer prospective international studies have mathematically integrated hospital structural capabilities and perioperative safety processes into multi-level predictive frameworks. This protocol describes an international, prospective, multicenter cohort study designed to build and validate a predictive model for adverse surgical outcomes. Study Design and Population: This is a multicenter, prospective cohort study. Participating centers will recruit consecutive adult or pediatric patients undergoing major elective or emergency non-cardiac surgery. Major surgery is defined internationally as any procedure requiring general or neuraxial anesthesia with an anticipated duration > 90 minutes, estimated blood loss > 500 mL, or requiring routine postoperative intensive care admission. Patients undergoing minor procedures or those unable to provide informed consent will be excluded. Data Collection and Covariates: Standardized electronic case report forms (eCRFs) will be used to collect data across three main tiers: 1. Patient-level Predictors: Demographics, insurance coverage, American Society of Anesthesiologists (ASA) physical status, Charlson Comorbidity Index, and frailty (measured via the Modified Frailty Index, mFI-5). 2. Procedure: code of surgery. 3. Type of surgery: Emergency/elective surgery, Ambulatory/hospitalized, severity, specialty. Outcomes and Follow-up: All participants will be systematically tracked during their inpatient stay, with mandatory clinical follow-up at postoperative day 30 (via medical record review). Primary Outcome: Composite incidence of major 30-day postoperative complications, graded according to the Clavien-Dindo classification (Grade > III, indicating complications requiring surgical, endoscopic, or radiological intervention, life-threatening complications, or death). Secondary Outcomes: 30-day all-cause mortality, individual complication rates (surgical site infections, major bleeding, thromboembolic events, organ failure), hospital length of stay, and "Failure to Rescue" rates (proportion of patients who die after developing a major complication). Statistical Analysis and Predictive Modeling: Sample size calculations are based on the Events Per Variable (EPV) criterion, ensuring a minimum of 15-20 events per candidate predictor in the multivariable model to prevent overfitting. Multilevel multivariable logistic regression and mixed-effects Cox proportional hazards models will be constructed, treating the hospital/country of origin as a random effect to account for institutional clustering. Model performance will be rigorously evaluated. Discriminatory capacity will be assessed using the area under the receiver operating characteristic curve (AUROC). Calibration will be assessed via calibration curves (observed vs. predicted risk). Sensitivity analyses will compare traditional regression models. Reporting will adhere strictly to TRIPOD and STROBE guidelines.
- Conditions
- Major Surgery
- Being tested
- Patients with postoperative complications
- Keywords
- Major Surgery, Operative Procedures, Developing Countries, Patient Safety, Surgery Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with postoperative complicationsOther
Patients with observed complications (Clavien-Dindo >3)
| Study group | Role | What they receive |
|---|---|---|
| Complications | Patients with postoperative complications Receives: Other: Patients with postoperative complications | |
| No complications | Patients with no postoperative complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined complications
Postoperative complications by Clavien-Dindo classification > 3
Measured: 30 days
Secondary outcomes (2)
Mortality
Patients with postoperative mortality before discharge or within 30 days.
Measured: 30 days
Surgical site infection
Surgical site infection according to clinical charts
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Major 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez-Gutiérrez, MD, Principal investigator, Hospital Departamental de Villavicencio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621198
- Sponsor's protocol ID
- GRIVI_2026_01_QX_COMPLIC
- Acronym
- SURGCOM
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient information involved.
Publications
Duclos A, Frits ML, Iannaccone C, Lipsitz SR, Cooper Z, Weissman JS, Bates DW. Safety of inpatient care in surgical settings: cohort study. BMJ. 2024 Nov 13;387:e080480. doi: 10.1136/bmj-2024-080480.
PubMed 39537329Blitzkow ACB, Freitas ACT, Coelho JCU, Campos ACL, Costa MARD, Buffara-Junior VA, Matias JEF. CRITICAL VIEW OF SAFETY: A PROSPECTIVE SURGICAL AND PHOTOGRAPHIC ANALYSIS IN LAPAROSCOPIC CHOLECYSTECTOMY - DOES IT HELP TO PREVENT IATROGENIC LESIONS? Arq Bras Cir Dig. 2024 Oct 25;37:e1827. doi: 10.1590/0102-6720202400034e1827. eCollection 2024.
PubMed 39475862Valli C, Schafer WLA, Baneres J, Groene O, Arnal-Velasco D, Leite A, Sunol R, Ballester M, Gibert Guilera M, Wagner C, Calsbeek H, Emond Y, J Heideveld-Chevalking A, Kristensen K, Huibertina Davida van Tuyl L, Polluste K, Weynants C, Garel P, Sousa P, Talving P, Marx D, Zaludek A, Romero E, Rodriguez A, Orrego C; SAFEST consortium. Improving quality and patient safety in surgical care through standardisation and harmonisation of perioperative care (SAFEST project): A research protocol for a mixed methods study. PLoS One. 2024 Jun 13;19(6):e0304159. doi: 10.1371/journal.pone.0304159. eCollection 2024.
PubMed 38870215Allaudeen N, Schalch E, Neff M, Poppler K, Vashi AA. Patient Safety Indicators at an Academic Veterans Affairs Hospital: Addressing Dual Goals of Clinical Care and Validity. Jt Comm J Qual Patient Saf. 2024 Sep;50(9):638-644. doi: 10.1016/j.jcjq.2024.04.010. Epub 2024 Apr 27.
PubMed 38821745Grygorian A, Montano D, Shojaa M, Ferencak M, Schmitz N. Digital Health Interventions and Patient Safety in Abdominal Surgery: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Apr 1;7(4):e248555. doi: 10.1001/jamanetworkopen.2024.8555.
PubMed 38669018Ruiz-Lopez PM, Fuente-Bartolome M, Perez-Zapata AI, Rodriguez-Cuellar E, Martin-Arriscado-Arroba C, Nogueras MG, Segurola CL, Sanchez AT; colaboradores del Grupo de Trabajo. Analysis of adverse events in general surgery. Multicenter study. Cir Esp (Engl Ed). 2024 Feb;102(2):76-83. doi: 10.1016/j.cireng.2023.07.006. Epub 2023 Nov 14.
PubMed 37967648Nepogodiev D, Picciochi M, Ademuyiwa A, Adisa A, Agbeko AE, Aguilera ML, Agyei F, Alexander P, Henry J, Anyomih TTK, Aregawi AB, Atun R, Biccard B, Chalwe M, Chu K, Coomarasamy A, Crawford R, Darzi A, Davies J, Gathuya Z, George C, Ghaffar A, Ghosh D, Glasbey JC, Haque PD, Harrison EM, Hesse A, Allen Ingabire JC, Kamarajah SK, Karekezi C, Kruger D, Lapitan MC, Latif A, Lawani I, Ledda V, Li E, Linder C, Makasa E, Martin J, Maswime S, Mathai S, Meara JG, Mudede-Moffat F, Ntirenganya F, Park KB, Phelan LN, Pramesh CS, Ramos-De la Medina A, Raykar N, Rivello R, Roslani AC, Roy N, Samad L, Shrime M, Sobhy S, Sullivan R, Tabiri S, Tangi V, Tissingh E, Weiser TG, Williams O, Bhangu A. Surgical health policy 2025-35: strengthening essential services for tomorrow's needs. Lancet. 2025 Aug 23;406(10505):860-880. doi: 10.1016/S0140-6736(25)00985-7. Epub 2025 Jul 14.
PubMed 40675172Gonzalez CM, Freire JOP, de Cerqueira CMDS, Paes GO. Predictive model of surgical infection to enhance patient safety: A retrospective cohort study. Rev Esc Enferm USP. 2025 Dec 1;59:e20250207. doi: 10.1590/1980-220X-REEUSP-2025-0207en. eCollection 2025.
PubMed 41329850Moumne OA, Carter GC, Devereaux TJ, Kieffer MC, Campbell HD, Kaiser JE. The perioperative education time-out and its impact on patient safety outcomes. BMC Med Educ. 2025 Oct 27;25(1):1500. doi: 10.1186/s12909-025-08107-5.
PubMed 41146132Peseski AM, Vail CJ, Kuchibhatla M, Hauser J, Bae J, Shannon RP, Sangvai D, Ortel TL, Wahidi MM. Multimodal quality improvement project on reducing hospital perioperative thromboembolic events (Patient Safety Indicator-12). BMJ Open Qual. 2025 Apr 3;14(2):e002937. doi: 10.1136/bmjoq-2024-002937.
PubMed 40185488Finsterwald M, Kita Z, Dell-Kuster S, Burri-Winkler K, Auderset A, Winkens J, Burkhart CS, van Vegten A, Clack L. Systematic recording and discussion of intraoperative adverse events using ClassIntra: results of a qualitative context analysis before implementation. Int J Qual Health Care. 2025 Apr 11;37(1):mzaf023. doi: 10.1093/intqhc/mzaf023.
PubMed 40085070Rossi N, Cortina-Borja M, Golinelli L, Bersani F, Geraci M. The association between surgical complications and compliance to the World Health Organization Surgical Safety Checklist: A retrospective analysis of hospital records. J Eval Clin Pract. 2025 Apr;31(3):e14208. doi: 10.1111/jep.14208. Epub 2024 Oct 18.
PubMed 39420800Sears S, Mitchell D, Sammarco A, Sheyn D. Relationship between patient safety indicator events and hospital location for inpatient hysterectomy. Minerva Obstet Gynecol. 2025 Apr;77(2):67-74. doi: 10.23736/S2724-606X.24.05431-9. Epub 2024 Mar 21.
PubMed 38512347Martin SV, Reed B, Fallico N. Patient Safety and Suitability for Primary Cleft Lip Repair as Day Case Surgery - A Systematic Review and Meta-Analysis. Cleft Palate Craniofac J. 2025 Jan;62(1):97-107. doi: 10.1177/10556656231199643. Epub 2023 Sep 5.
PubMed 37670486Diskin B, Hopkins MA. Surgery in Low-Income and Middle-Income Countries. Surg Clin North Am. 2025 Dec;105(6):1021-1024. doi: 10.1016/j.suc.2025.07.003. Epub 2025 Sep 4.
PubMed 41167864
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Complications in Major Surgery: A Prospective, Multicenter, Cohort Study in Low- and Middle-income Settings
- ClinicalTrials.gov ID
- NCT07621198
- Acronym / sponsor ID
- SURGCOM / GRIVI_2026_01_QX_COMPLIC
- Conditions
- Major Surgery
- Keywords
- Major Surgery, Operative Procedures, Developing Countries, Patient Safety, Surgery Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 2 Jun 2026 (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 primary objective of this study is to develop and validate a multivariable risk prediction model for 30-day major postoperative complications and mortality in patients undergoing major surgery across participating international centers. Despite advancements in perioperative care, surgical complications remain a leading cause of global morbidity and preventable death, particularly in resource-limited or low- and middle-income country (LMIC) settings.
This study utilizes a prospective, multicenter, international cohort design. Data will be collected on patient-level risk factors (e.g., age, frailty, comorbidities), hospital-level infrastructure (e.g., nurse-to-patient ratios, rescue capacity), and perioperative safety processes (e.g., adherence to the WHO Surgical Safety Checklist). Patients will be followed prospectively for up to 30 days post-surgery. The collected data will be used to construct robust predictive models to identify individual patient risk and uncover actionable system-level factors to optimize surgical safety globally.
Detailed description
Background and Rationale: Postoperative complications impose a substantial clinical and economic burden worldwide. While extensive research has focused on patient-derived clinical risks, fewer prospective international studies have mathematically integrated hospital structural capabilities and perioperative safety processes into multi-level predictive frameworks. This protocol describes an international, prospective, multicenter cohort study designed to build and validate a predictive model for adverse surgical outcomes. Study Design and Population: This is a multicenter, prospective cohort study. Participating centers will recruit consecutive adult or pediatric patients undergoing major elective or emergency non-cardiac surgery. Major surgery is defined internationally as any procedure requiring general or neuraxial anesthesia with an anticipated duration > 90 minutes, estimated blood loss > 500 mL, or requiring routine postoperative intensive care admission. Patients undergoing minor procedures or those unable to provide informed consent will be excluded. Data Collection and Covariates: Standardized electronic case report forms (eCRFs) will be used to collect data across three main tiers: 1. Patient-level Predictors: Demographics, insurance coverage, American Society of Anesthesiologists (ASA) physical status, Charlson Comorbidity Index, and frailty (measured via the Modified Frailty Index, mFI-5). 2. Procedure: code of surgery. 3. Type of surgery: Emergency/elective surgery, Ambulatory/hospitalized, severity, specialty. Outcomes and Follow-up: All participants will be systematically tracked during their inpatient stay, with mandatory clinical follow-up at postoperative day 30 (via medical record review). Primary Outcome: Composite incidence of major 30-day postoperative complications, graded according to the Clavien-Dindo classification (Grade > III, indicating complications requiring surgical, endoscopic, or radiological intervention, life-threatening complications, or death). Secondary Outcomes: 30-day all-cause mortality, individual complication rates (surgical site infections, major bleeding, thromboembolic events, organ failure), hospital length of stay, and "Failure to Rescue" rates (proportion of patients who die after developing a major complication). Statistical Analysis and Predictive Modeling: Sample size calculations are based on the Events Per Variable (EPV) criterion, ensuring a minimum of 15-20 events per candidate predictor in the multivariable model to prevent overfitting. Multilevel multivariable logistic regression and mixed-effects Cox proportional hazards models will be constructed, treating the hospital/country of origin as a random effect to account for institutional clustering. Model performance will be rigorously evaluated. Discriminatory capacity will be assessed using the area under the receiver operating characteristic curve (AUROC). Calibration will be assessed via calibration curves (observed vs. predicted risk). Sensitivity analyses will compare traditional regression models. Reporting will adhere strictly to TRIPOD and STROBE guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complications | – | Other: Patients with postoperative complicationsPatients with postoperative complications |
| No complications | – | –Patients with no postoperative complications |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients included in the study are those with a major operative procedure during a window opportunity of 7 days.
Key inclusion criteria (4 listed)
- Major surgery
- Adult or pediatric patients
- Emergency or elective surgery
- Ambulatory or hospitalized patients
Key exclusion criteria (1 listed)
- Patients derived to other institution
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 |
|---|---|---|
| Patients with postoperative complicationsPatients with observed complications (Clavien-Dindo >3) | Other | Complications |
Primary outcome
Combined complications
Time frame: 30 days
Postoperative complications by Clavien-Dindo classification > 3
2 secondary outcomes
Mortality
Time frame: 30 days
Surgical site infection
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Results publication: PubMed 39537329Duclos A, Frits ML, Iannaccone C, Lipsitz SR, Cooper Z, Weissman JS, Bates DW. Safety of inpatient care in surgical settings: cohort study. BMJ. 2024 Nov 13;387:e080480. doi: 10.1136/bmj-2024-080480.
- Results publication: PubMed 39475862Blitzkow ACB, Freitas ACT, Coelho JCU, Campos ACL, Costa MARD, Buffara-Junior VA, Matias JEF. CRITICAL VIEW OF SAFETY: A PROSPECTIVE SURGICAL AND PHOTOGRAPHIC ANALYSIS IN LAPAROSCOPIC CHOLECYSTECTOMY - DOES IT HELP TO PREVENT IATROGENIC LESIONS? Arq Bras Cir Dig. 2024 Oct 25;37:e1827. doi: 10.1590/0102-6720202400034e1827. eCollection 2024.
- Results publication: PubMed 38870215Valli C, Schafer WLA, Baneres J, Groene O, Arnal-Velasco D, Leite A, Sunol R, Ballester M, Gibert Guilera M, Wagner C, Calsbeek H, Emond Y, J Heideveld-Chevalking A, Kristensen K, Huibertina Davida van Tuyl L, Polluste K, Weynants C, Garel P, Sousa P, Talving P, Marx D, Zaludek A, Romero E, Rodriguez A, Orrego C; SAFEST consortium. Improving quality and patient safety in surgical care through standardisation and harmonisation of perioperative care (SAFEST project): A research protocol for a mixed methods study. PLoS One. 2024 Jun 13;19(6):e0304159. doi: 10.1371/journal.pone.0304159. eCollection 2024.
- Results publication: PubMed 38821745Allaudeen N, Schalch E, Neff M, Poppler K, Vashi AA. Patient Safety Indicators at an Academic Veterans Affairs Hospital: Addressing Dual Goals of Clinical Care and Validity. Jt Comm J Qual Patient Saf. 2024 Sep;50(9):638-644. doi: 10.1016/j.jcjq.2024.04.010. Epub 2024 Apr 27.
- Results publication: PubMed 38669018Grygorian A, Montano D, Shojaa M, Ferencak M, Schmitz N. Digital Health Interventions and Patient Safety in Abdominal Surgery: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Apr 1;7(4):e248555. doi: 10.1001/jamanetworkopen.2024.8555.
- Results publication: PubMed 37967648Ruiz-Lopez PM, Fuente-Bartolome M, Perez-Zapata AI, Rodriguez-Cuellar E, Martin-Arriscado-Arroba C, Nogueras MG, Segurola CL, Sanchez AT; colaboradores del Grupo de Trabajo. Analysis of adverse events in general surgery. Multicenter study. Cir Esp (Engl Ed). 2024 Feb;102(2):76-83. doi: 10.1016/j.cireng.2023.07.006. Epub 2023 Nov 14.
- Results publication: PubMed 40675172Nepogodiev D, Picciochi M, Ademuyiwa A, Adisa A, Agbeko AE, Aguilera ML, Agyei F, Alexander P, Henry J, Anyomih TTK, Aregawi AB, Atun R, Biccard B, Chalwe M, Chu K, Coomarasamy A, Crawford R, Darzi A, Davies J, Gathuya Z, George C, Ghaffar A, Ghosh D, Glasbey JC, Haque PD, Harrison EM, Hesse A, Allen Ingabire JC, Kamarajah SK, Karekezi C, Kruger D, Lapitan MC, Latif A, Lawani I, Ledda V, Li E, Linder C, Makasa E, Martin J, Maswime S, Mathai S, Meara JG, Mudede-Moffat F, Ntirenganya F, Park KB, Phelan LN, Pramesh CS, Ramos-De la Medina A, Raykar N, Rivello R, Roslani AC, Roy N, Samad L, Shrime M, Sobhy S, Sullivan R, Tabiri S, Tangi V, Tissingh E, Weiser TG, Williams O, Bhangu A. Surgical health policy 2025-35: strengthening essential services for tomorrow's needs. Lancet. 2025 Aug 23;406(10505):860-880. doi: 10.1016/S0140-6736(25)00985-7. Epub 2025 Jul 14.
- Results publication: PubMed 41329850Gonzalez CM, Freire JOP, de Cerqueira CMDS, Paes GO. Predictive model of surgical infection to enhance patient safety: A retrospective cohort study. Rev Esc Enferm USP. 2025 Dec 1;59:e20250207. doi: 10.1590/1980-220X-REEUSP-2025-0207en. eCollection 2025.
- Results publication: PubMed 41146132Moumne OA, Carter GC, Devereaux TJ, Kieffer MC, Campbell HD, Kaiser JE. The perioperative education time-out and its impact on patient safety outcomes. BMC Med Educ. 2025 Oct 27;25(1):1500. doi: 10.1186/s12909-025-08107-5.
- Results publication: PubMed 40185488Peseski AM, Vail CJ, Kuchibhatla M, Hauser J, Bae J, Shannon RP, Sangvai D, Ortel TL, Wahidi MM. Multimodal quality improvement project on reducing hospital perioperative thromboembolic events (Patient Safety Indicator-12). BMJ Open Qual. 2025 Apr 3;14(2):e002937. doi: 10.1136/bmjoq-2024-002937.
- Results publication: PubMed 40085070Finsterwald M, Kita Z, Dell-Kuster S, Burri-Winkler K, Auderset A, Winkens J, Burkhart CS, van Vegten A, Clack L. Systematic recording and discussion of intraoperative adverse events using ClassIntra: results of a qualitative context analysis before implementation. Int J Qual Health Care. 2025 Apr 11;37(1):mzaf023. doi: 10.1093/intqhc/mzaf023.
- Results publication: PubMed 39420800Rossi N, Cortina-Borja M, Golinelli L, Bersani F, Geraci M. The association between surgical complications and compliance to the World Health Organization Surgical Safety Checklist: A retrospective analysis of hospital records. J Eval Clin Pract. 2025 Apr;31(3):e14208. doi: 10.1111/jep.14208. Epub 2024 Oct 18.
- Individual participant dataSharing planned: No. Patient information involved.
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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.
Norton Perez-Gutiérrez, MD principal investigator
Hospital Departamental de Villavicencio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Surgery, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
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 1 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: opening soon, as of the sponsor's last update on 2 Jun 2026. 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 Colombia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norton Perez-Gutiérrez, MD (+573112517471, norton.perez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined complications (time frame: 30 days). 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 NCT07621198, which also lists 17 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 2 Jun 2026.