To Assess the Impact of theERAS Consensus on Patients With Endoscopic Pituitary Tumor Surgery

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Postoperative Complications; Pituitary Tumor; Enhanced Recovery After Surgery

Treatments: Device: TIB Olfactory Test Device; Behavioral: BDI-II(Beck Depression Inventory-II); Diagnostic Test: Apfel Score for Postoperative nausea and vomiting; Behavioral: Quality of Recovery-40(QoR-40); Behavioral: World Health Organization Quality of Life questionnaire (WHOQOL-BREF); Behavioral: ERAS Patient Satisfaction Questionnaire(ERAS-PSQ); Behavioral: Short Form-36; Diagnostic Test: Malnutrition Universal Screening Tool; Diagnostic Test: The American Society of Anesthesiologists (ASA) Physical Status Classification

Study type: Observational

Funder types: Other

Identifiers

NCT06221020

202300876B0A3

Details and patient eligibility

About

The goal of this observational study is to evaluate the effectiveness and impact of Enhanced Recovery After Surgery (ERAS) on patients with pituitary gland tumors.

Full description

The goal of this observational study is to evaluate the effectiveness and impact of Enhanced Recovery After Surgery (ERAS) on patients with pituitary gland tumors. This study is particularly significant as ERAS has been a prominent focus in international medical treatment, emphasizing improved patient recovery and safety. The main questions it aims to answer are:

How does ERAS affect the effectiveness and prognosis of patients with pituitary gland tumors? Which specific inspection and evaluation items within the ERAS protocol genuinely assist patients? Participants in this study will undergo various ERAS protocols, including pre-operative to post-operative rehabilitation measures, pain management, surgical techniques, and early resumption of eating and activities. This comprehensive approach is designed to reduce complications, shorten hospital stays, and speed up patient recovery.

Additionally, this study will conduct a thorough statistical analysis to determine which aspects of the ERAS protocol are most beneficial. By comparing the outcomes of patients undergoing the ERAS protocol with those who do not, researchers aim to understand better the balance between ERAS and the Choosing Wisely initiative, which advocates for reducing unnecessary medical interventions.

This research is crucial in advancing medical knowledge and practice, particularly in managing pituitary gland tumors, and contributes to the broader goals of enhancing medical quality and patient safety.

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of pituitary tumors
• To sign a written informed consent form

Exclusion criteria

• Diagnosed with other malignant tumors
• Severe infections, such as osteomyelitis, acute inflammation at the affected site, or open wounds at the treatment area
• Pregnant women
• Coagulation disorders or those taking anticoagulant medication
• Other central nervous system disorders, alcohol addiction, other addictive drugs, or mental illness that may affect clinical assessment
• Deemed unsuitable for surgical treatment or unable to comply with clinical evaluation upon assessment

Trial design

70 participants in 2 patient groups

Patients with ERAS

Description:

In the experimental group (Patients with ERAS), participants will undergo an assessment of the Enhanced Recovery After Surgery (ERAS) consensus items. The experimental group will complete all the items on the ERAS forms as far as possible. All groups will undergo our routine preoperative evaluation for pituitary tumor surgery, such as cardiopulmonary function, hormone testing, vision and visual field examination, etc. The care during hospitalization and surgery will be the same as previously for patients with pituitary tumors, and the post-discharge outpatient follow-up will also be the same as for patients who have undergone pituitary tumor surgery.

Treatment:

Device: TIB Olfactory Test Device

Diagnostic Test: Malnutrition Universal Screening Tool

Diagnostic Test: The American Society of Anesthesiologists (ASA) Physical Status Classification

Behavioral: ERAS Patient Satisfaction Questionnaire(ERAS-PSQ)

Behavioral: Short Form-36

Behavioral: World Health Organization Quality of Life questionnaire (WHOQOL-BREF)

Diagnostic Test: Apfel Score for Postoperative nausea and vomiting

Behavioral: Quality of Recovery-40(QoR-40)

Behavioral: BDI-II(Beck Depression Inventory-II)

Patients with Regular

Description:

In the control group (Patients with Regular), participants will only complete the routine items as before. All groups will undergo our routine preoperative evaluation for pituitary tumor surgery, such as cardiopulmonary function, hormone testing, vision and visual field examination, etc. The care during hospitalization and surgery will be the same as previously for patients with pituitary tumors, and the post-discharge outpatient follow-up will also be the same as for patients who have undergone pituitary tumor surgery.

Treatment:

Device: TIB Olfactory Test Device

Diagnostic Test: Malnutrition Universal Screening Tool

Diagnostic Test: The American Society of Anesthesiologists (ASA) Physical Status Classification

Behavioral: ERAS Patient Satisfaction Questionnaire(ERAS-PSQ)

Behavioral: Short Form-36

Behavioral: World Health Organization Quality of Life questionnaire (WHOQOL-BREF)

Diagnostic Test: Apfel Score for Postoperative nausea and vomiting

Behavioral: Quality of Recovery-40(QoR-40)

Behavioral: BDI-II(Beck Depression Inventory-II)