NCT06998030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

29 days

First QC Date

May 13, 2025

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Complication Rate

    The proportion of patients experiencing any postoperative complication (including but not limited to pulmonary complications, infections, or other adverse events) within 30 days after surgery, as assessed by clinical records and standardized criteria (e.g., Clavien-Dindo classification)

    within 30 days after surgery

Secondary Outcomes (5)

  • Length of Hospital Stay

    postoperative first 30 days

  • Postoperative Intensive Care Unit (ICU) Admission

    immediately after the surgery

  • Length of ICU Stay

    30 days after surgery

  • 30-day Postoperative Mortality

    within 30 days after surgery

  • Incidence of Specific Postoperative Pulmonary Complications

    30 days after surgery

Study Arms (2)

Group 1 (<3.5 g/dL, hypoalbuminemia)

Participants with preoperative serum albumin levels less than 3.5 g/dL. This group represents geriatric cancer surgery patients who are considered to have hypoalbuminemia, indicating poor nutritional and/or inflammatory status prior to surgery.

Group 2 (≥3.5 g/dL, normal)

Participants with preoperative serum albumin levels equal to or greater than 3.5 g/dL. This group represents geriatric cancer surgery patients with normal preoperative albumin levels, reflecting adequate nutritional and inflammatory status prior to surgery.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 36455266BACKGROUND
  • 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.

    PMID: 27765612BACKGROUND
  • 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.

    PMID: 30908744BACKGROUND
  • 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.

    PMID: 33568020BACKGROUND

MeSH Terms

Conditions

NeoplasmsHypoalbuminemiaPostoperative ComplicationsMalnutrition

Condition Hierarchy (Ancestors)

HypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Mustafa Kemal SAHIN

    MUSTAFA KEMAL SAHİN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 31, 2025

Study Start

April 1, 2025

Primary Completion

April 30, 2025

Study Completion

May 10, 2025

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations