Clinical trials

The goal of this observational study is to learn whether injecting a numbing medicine (levobupivacaine, a local anesthetic) into the surgical wound at the end of a cesarean delivery improves pain control in women who also receive spinal morphine. Spinal morphine is the standard pain treatment for cesarean delivery. The main questions it aims to answer are: Do women who receive wound infiltration with levobupivacaine report less pain at 24 hours, 48 hours, and 7 days after surgery than women who do not? Do they have a better quality of recovery, measured with the ObsQoR-10 questionnaire? Do they walk for the first time sooner, and do they need less additional ("rescue") pain medicine in the first 24 hours? Researchers will compare two groups of women having a scheduled cesarean delivery under spinal anesthesia at Fundación Santa Fe de Bogotá (Bogotá, Colombia). In the first group, the surgeon routinely infiltrates the wound with levobupivacaine when closing. In the second group, the surgeon does not. The study team does not decide which women receive the medicine; this depends only on each surgeon's usual practice. All participants receive the same standard hospital pain treatment: spinal morphine, acetaminophen, and anti-inflammatory medicines. Participants will: Receive their usual cesarean care, with no extra procedures because of the study. Answer short online questionnaires sent by WhatsApp or email at 24 hours, 48 hours, and 7 days after surgery. They will rate their pain on a 0-10 scale at each time point and their recovery with the ObsQoR-10 questionnaire at 24 hours. Receive a phone call on day 7 reminding them to complete the last questionnaire. Allow the research team to collect information from their medical record, such as the time to first walk and the use of rescue pain medicine. The study plans to include 336 women over about 10 months.

Perioperative chemotherapy with the FLOT regimen (5-fluorouracil, leucovorin, oxaliplatin and docetaxel) is a standard treatment for resectable gastric and gastroesophageal junction adenocarcinoma. However, real-world studies have reported lower pathological complete response rates than the pivotal trials, and Colombian evidence is limited, coming mainly from surgical series focused on operative outcomes. This descriptive retrospective study will review the medical records of adults with stage I to III gastric or gastroesophageal junction adenocarcinoma who started perioperative FLOT at Fundación Santa Fe de Bogotá (Bogotá, Colombia) between January 1, 2021 and December 31, 2025 (approximately 90 patients). It will describe pathological response (tumor regression grade by the Mandard system and pathological complete response), grade 3-4 toxicity, dose modifications, treatment adherence and completion, recurrence and overall survival. The investigators will not assign or modify any treatment, and no hypothesis testing will be performed.

Metastatic gastric cancer has a poor prognosis, and the cumulative toxicity of first-line platinum and fluoropyrimidine chemotherapy limits how long treatment can be continued. Maintenance therapy, in which patients whose disease is at least stable after induction chemotherapy continue on a less toxic regimen, is increasingly used, most often with fluoropyrimidines (capecitabine, 5-fluorouracil or S-1) and, in selected molecular subgroups, with immunotherapy or targeted therapy. Evidence on the outcomes of these strategies in Latin American patients is scarce. This multicenter retrospective study will review the medical records of adults with metastatic gastric cancer treated between 2013 and 2023 at four high-complexity cancer centers in Bogotá, Colombia, who received maintenance therapy after achieving at least stable disease with induction chemotherapy. The study will describe the demographic, clinical, pathological and molecular characteristics of these patients and estimate overall survival, progression-free survival, treatment response, toxicity and mortality. The investigators will not assign or modify any treatment.

Breast cancer is the most common cancer in women worldwide. Its molecular classification, based on hormone receptors (estrogen and progesterone), HER2 and Ki-67, defines subtypes with different prognoses and treatments. In Colombia, there is limited information that integrates the clinical, treatment, sociodemographic and contextual characteristics of each subtype, and limited data on the direct medical costs of breast cancer care. This retrospective cohort study will review the medical records of women 18 years or older with biopsy-confirmed breast cancer and a documented molecular subtype who were treated at Fundación Santa Fe de Bogotá (Bogotá, Colombia) between January 1, 2014 and December 31, 2024. It will describe each molecular subtype (luminal A, luminal B HER2-negative, luminal B HER2-positive, HER2-enriched, triple-negative and HER2-low) and evaluate the association of clinical, molecular and treatment characteristics with overall survival, progression-free survival, recurrence, treatment response and grade 3-4 adverse events. It will also explore the impact of the COVID-19 pandemic and health insurance regimen on outcomes, and estimate direct medical costs of breast cancer care by clinical stage and phase of care. The investigators will not assign or modify any treatment.

This observational study will evaluate the long-term effectiveness, safety, and patient satisfaction associated with sacral neuromodulation using the InterStim™ system in adults treated for lower urinary tract dysfunction at Fundación Santa Fe de Bogotá. The study will include patients who underwent definitive InterStim implantation between January 2010 and June 2026 for conditions including overactive bladder, urgency urinary incontinence, non-obstructive acontractile detrusor, or non-obstructive urinary retention. Clinical information before implantation, details of the procedure, complications, reinterventions, device replacements, and explantations will be obtained retrospectively from medical records. Patients who can be contacted will also complete a single telephone follow-up assessment to evaluate current urinary symptoms, perceived improvement, satisfaction with treatment, catheter use, and current device status. The study aims to describe the long-term effectiveness and safety of InterStim therapy in a Colombian population, including changes in urinary incontinence, patient-reported improvement and satisfaction, complications, therapeutic failure, and device survival.

PCSK9 inhibitors, including evolocumab and alirocumab, are lipid-lowering therapies used in patients with hyperlipidemia and atherosclerotic cardiovascular disease. This retrospective observational study aims to describe changes in low-density lipoprotein cholesterol (LDL-C) levels following the use of PCSK9 inhibitors in adult patients with hyperlipidemia and/or atherosclerotic cardiovascular disease treated at Fundación Santa Fe de Bogotá between 2018 and 2024. The study will also describe patients' clinical characteristics, treatment effectiveness, safety, adherence, and barriers to treatment access. Data will be obtained from medical records, cardiology records, and telephone interviews when needed to complete missing information.

Malignant bowel obstruction is a frequent complication of advanced cancer, particularly of abdominal and pelvic origin, and most affected patients experience pain. Opioids are the mainstay of analgesic treatment, but some patients have pain that does not respond adequately or cannot tolerate further opioid dose increases. Lidocaine infusions are sometimes used as an adjuvant pain treatment in this setting, but specific evidence is limited to case reports and small series. This retrospective cohort study will review the medical records of adults with cancer and malignant bowel obstruction who received lidocaine infusions for pain as part of routine palliative care at Hospital Universitario Fundación Santa Fe de Bogotá (Bogotá, Colombia) between 2015 and 2025. The study will describe patient characteristics and lidocaine regimens, and will evaluate changes in pain intensity and opioid requirements before and after the start of the infusion, the proportion of patients with a clinically meaningful pain reduction, adverse events, treatment discontinuation due to toxicity, and hospital outcomes. The investigators will not assign or modify any treatment.

Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic therapy (HT), whose effectiveness-among other factors-depends on adequate pain management. Considering the prevalence of allodynia in this group of patients, routine nursing procedures can become sources of additional stress and pain. Music therapy is used in this population to promote self-regulation and relaxation, and may therefore help reduce pain levels after routine nursing procedures. Research question: What is the effect of an entrainment-based live music therapy intervention on pain levels in newborns with hypoxic-ischemic encephalopathy undergoing hypothermic therapy after routine nursing procedures? Methodology: A randomized, crossover pilot and feasibility study. Participants will be 22 newborns admitted to the Neonatal Intensive Care Unit (NICU) of the University Hospital Fundación Santa Fe de Bogotá. Participants will receive standard care plus a 15-minute live music therapy session after a routine nursing procedure, or standard care alone. The primary outcome is the Premature Infant Pain Profile-Revised (PIPP-R) scale, which will be assessed through video recordings. Secondary outcomes are vital signs, heart rate variability, and electroencephalography (EEG) recordings. Expected outcomes: Through this study, the aim is to improve the comfort and well-being of patients with HIE during TH. In addition, the safety and feasibility of music therapy in this population will be evaluated, seeking to contribute to current knowledge about the mechanisms of music therapy.

Background: Healthcare professionals in emergency departments frequently experience stressful situations that could jeopardize their mental health, sense of purpose, and ability to empathize with patients, families, and colleagues. Research question: What is the impact of a short music therapy program on the intra- and interpersonal factors of humanized care among emergency nursing staff at the University Hospital Fundación Santa Fe de Bogotá (FSFB)? Methodology: This research is a mixed-methods pilot and feasibility study. For the quantitative component, we will apply the HUMAS (Healthcare Professional Humanization Scale) and ProQOL (Professional Quality of Life) measure at the start and at the end of the music therapy program. For the qualitative component, focus group interviews will be conducted and analyzed via thematic analysis. Discussion: This study seeks to support the nursing staff of the FSFB emergency department through an interactive, creative, and participatory music therapy self-care program focused on one of the most important pillars of the institution: the humanization of care.

To assess the association between early multimodal therapy and the duration of invasive mechanical ventilation in the Intensive Care Unit at Fundación Santa Fe de Bogotá.

Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group