Clinical trial NCT06998030: Silent Threat: Impact of Preoperative Albumin Levels on Outcomes in Geriatric Cancer Surgery
Official title: Silent Threat: How Do Preoperative Albumin Levels Affect Outcomes in Geriatric Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Aged
Hypoalbuminemia
Postoperative Complications
Malnutrition
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 330
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include geriatric patients aged 65 years and older who underwent elective cancer surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. All participants must have a documented preoperative serum albumin level. Patients with emergency or palliative surgery, active infection or inflammatory disease, or missing/incomplete medical records will be excluded. The study population represents a real-world cohort of elderly cancer patients at increased risk for postoperative complications due to age-related physiological changes and comorbidities.

Brief summary: This retrospective, single-center study aims to evaluate the impact of preoperative albumin levels on postoperative outcomes in geriatric patients (aged 65 and above) undergoing cancer surgery. The study will compare postoperative complication rates, length of hospital stay, and intensive care needs between patients with hypoalbuminemia and those with normal albumin levels.

Detailed description: Malnutrition is a significant risk factor for postoperative complications in elderly cancer patients. Preoperative serum albumin is a key biomarker reflecting nutritional and inflammatory status. This study will retrospectively review the medical records of 330 geriatric patients (≥65 years) who underwent cancer surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Patients will be grouped according to preoperative albumin levels: Group 1 (\<3.5 g/dL, hypoalbuminemia) and Group 2 (≥3.5 g/dL, normal). The primary aim is to compare postoperative complication rates, length of hospital stay, and intensive care requirements between these groups. The findings are expected to clarify the prognostic value of albumin and support individualized perioperative management in geriatric cancer surgery.

Eligibility criteria: Inclusion Criteria:

* Age 65 years or older
* Diagnosed with cancer and underwent cancer surgery
* Preoperative albumin level recorded before surgery

Exclusion Criteria:

* Preoperative sepsis, severe infection, or active inflammatory disease
* Emergency or palliative surgery
* Missing preoperative albumin value
* Incomplete medical records or follow-up data

Primary outcomes:
measure: Postoperative Complication Rate
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: postoperative first 30 days
measure: Postoperative Intensive Care Unit (ICU) Admission
timeFrame: immediately after the surgery
measure: Length of ICU Stay
timeFrame: 30 days after surgery
measure: 30-day Postoperative Mortality
timeFrame: within 30 days after surgery
measure: Incidence of Specific Postoperative Pulmonary Complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
state: Yenimahalle
Study officials:
affiliation: MUSTAFA KEMAL SAHİN
name: Mustafa Kemal SAHIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song S, Qiu P, Wang H, Zhang D, Qi Q, Feng L. Low preoperative serum prealbumin levels and risk of postoperative complications after transsphenoidal surgery in nonfunctioning pituitary adenoma. Neurosurg Focus. 2022 Dec;53(6):E6. doi: 10.3171/2022.9.FOCUS22211.
citation: Caras RJ, Lustik MB, Kern SQ, McMann LP, Sterbis JR. Preoperative Albumin Is Predictive of Early Postoperative Morbidity and Mortality in Common Urologic Oncologic Surgeries. Clin Genitourin Cancer. 2017 Apr;15(2):e255-e262. doi: 10.1016/j.clgc.2016.09.008. Epub 2016 Sep 23.
citation: Loftus TJ, Brown MP, Slish JH, Rosenthal MD. Serum Levels of Prealbumin and Albumin for Preoperative Risk Stratification. Nutr Clin Pract. 2019 Jun;34(3):340-348. doi: 10.1002/ncp.10271. Epub 2019 Mar 25.
citation: Heise D, Bednarsch J, Kroh A, Schipper S, Eickhoff R, Lang S, Neumann U, Ulmer F. Operative Time, Age, and Serum Albumin Predict Surgical Morbidity After Laparoscopic Liver Surgery. Surg Innov. 2021 Dec;28(6):714-722. doi: 10.1177/1553350621991223. Epub 2021 Feb 10.