Clinical trial NCT06988696: The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery
Official title: The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Tumor
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effect of perioperative use of heated socks on the prevention of hypothermia and its impact on vital signs in patients undergoing bladder tumor surgery. It is anticipated that the data obtained from the study will provide evidence that the use of perioperative heated socks can help prevent hypothermia and positively influence vital signs in patients undergoing bladder tumor surgery.

Detailed description: Bladder cancer accounts for 2-3% of all malignant tumors and constitutes 6-8% of all malignancies in men and 2-3% in women. Globally, it ranks as the seventh most common cancer in men and the seventeenth in women. Bladder cancer is a significant cause of morbidity and mortality worldwide, with approximately 350,000 new cases and 150,000 deaths annually. At the time of initial diagnosis, around 75% of patients with bladder tumors are diagnosed with non-muscle-invasive bladder cancer. Of those with muscle-invasive bladder cancer, 20% are cases that have progressed from lower-stage disease. If left untreated, approximately 85% of patients with muscle-invasive bladder cancer will die from the disease . For invasive bladder tumors, the gold standard treatment is radical cystectomy. Radical cystectomy combined with pelvic lymph node dissection provides the best disease-specific survival in patients with invasive bladder tumors . Following radical cystectomy, the average 10-year disease-free survival rate is approximately 50-66%.

During the surgical process, heat loss may occur due to the evaporation of cold solutions or through perspiration. Additional factors contributing to heat loss include the patient's exposure to the operating room environment without clothing, radiation exposure, and conduction due to contact with cold materials or the stretcher. Furthermore, preoperative hypothermia, fasting, and fluid deprivation; exposure of large body surface areas during surgery; use of volatile solutions for skin preparation; evaporation of cold solutions; perspiration; major open cavity surgical interventions; administration of cold IV fluids; prolonged surgical duration and exposure to anesthesia; intraoperative blood loss; peripheral vasodilation; anesthetic drugs; absence of clothing in the operating room; radiation; contact with cold materials or the stretcher; and impaired normal thermoregulation are all factors that may contribute to hypothermia.

Eligibility criteria: Inclusion Criteria:

* The duration of surgical intervention is between 2 and 4 hours,
* Ability to read, write, understand and communicate in Turkish,
* Voluntary participation in the study,
* Does not require follow-up in intensive care before or after surgery,
* Dementia, alzheimer etc. absence of disease affecting cognitive functions,
* Absence of a disease that may affect thermoregulation due to systemic effects such as chronic obstructive pulmonary disease (COPD), cancer, intracranial benign/malignant tumor, epilepsy, multiple sclerosis, Parkinson's disease, and thyroid-related diseases,
* Absence of drug use that may affect thermoregulation,
* It is not uncomfortable to wear heat socks during application.

Exclusion Criteria:

* Mental retardation and the presence of any psychiatric disorder,
* Being addicted to alcohol and drugs,
* Dementia, alzheimer etc. have a disease that affects cognitive functions,
* Having drug use that may affect thermoregulation,
* Discomfort from wearing heat socks during application,
* Having any disease that affects tissue perfusion,
* Presence of any peripheral arterial and venous disease,
* The need for intensive care before or after surgery

Primary outcomes:
measure: The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery:A Randomized Controlled Trial
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Seval Ulubay
state: Atakum/Samsun
Study officials:
affiliation: SAMSUN GAZI STATE HOSPITAL
name: SEVAL ULUBAY, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauronen SL, Kalliomaki ML, Aho AJ, Kalliovalkama J, Riikonen JM, Makinen MT, Leppikangas HM, Yli-Hankala AM. Thermal suit in preventing unintentional intraoperative hypothermia during general anaesthesia: a randomized controlled trial. Acta Anaesthesiol Scand. 2017 Oct;61(9):1133-1141. doi: 10.1111/aas.12945. Epub 2017 Jul 25.