To Assess the Impact of theERAS Consensus on Patients With Endoscopic Pituitary Tumor Surgery
To Assess the Impact of the Enhanced Recovery After Surgery (ERAS) Consensus on the Effectiveness and Prognosis of Patients With Endoscopic Pituitary Tumor Surgery
1 other identifier
observational
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2023
CompletedStudy Start
First participant enrolled
December 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedJanuary 24, 2024
December 1, 2023
12 months
December 4, 2023
January 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Surgical complications
any complications associated with this operation
three months after operation
Postoperative pain assessment
describe postoperative Visual analogue scale (VAS) for pain assessment; the minimum value is 0 (no pain) and maximum value is 10 (most pain)
During the hospitalization period, up to 24 weeks
Postoperative vomiting assessment
describe postoperative vomiting status; 0=no; 1=mild, 2=moderate, 3=severe
During the postoperative period, up to 7 days
Postoperative nausea assessment
describe postoperative nausea status; 0=no; 1=mild, 2=moderate, 3=severe
During the postoperative period, up to 7 days
Reoperation during hospitalization
Reoperation during hospitalization related to this surgery.
During the hospitalization period, the time from the first surgery to the reoperation is related to this surgical procedure, assessment up to 12 weeks.
Length of hospital stay
days of hospitalization related to this surgery.
The duration from the day of admission to the day of discharge, which is associated with this surgical procedure, assessment up to 12 weeks.
Readmission within 30 days
Readmission within 30 days related to this surgery.
within 30 days related to this surgery.
Secondary Outcomes (5)
Psychological stress- BDI-II
through study completion, an average of 1 year
Psychological stress- QoR-40
through study completion, an average of 1 year
Quality of life: Short Form-36
through study completion, an average of 1 year
Quality of life: WHOQOL-BREF
through study completion, an average of 1 year
ERAS Patient Satisfaction Questionnaire
through study completion, an average of 1 year
Study Arms (2)
Patients with ERAS
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.
Patients with Regular
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.
Interventions
The Malnutrition Universal Screening Tool (MUST) is a commonly used tool for assessing the nutritional status of adult patients. It is designed to identify early whether a patient is at risk of malnutrition or is already malnourished, enabling timely intervention and treatment. MUST includes three main assessment criteria: Body Mass Index (BMI): Degree of Weight Loss: This assesses the patient's weight change over the past three months, with grading based on the extent of weight loss. Effect of Illness on Dietary Intake: This evaluates the impact of illness on the patient's dietary intake, with grading based on the reduction in dietary intake. By combining the grades from these three assessment indicators, a final MUST score is obtained to determine the patient's nutritional status and level of risk. Based on the MUST score, patients can be categorized as low risk, medium risk, or high risk for malnutrition.
Olfactory testing is conducted on patients undergoing pituitary tumor surgery via nasal endoscopy using the TIB Olfactory Test Device (TIBSIT). This testing aims to compare olfactory (sense of smell) outcomes before and after the surgery. The olfactory tests are performed preoperatively and then again at the 3-month postoperative mark to assess any changes or impacts on the sense of smell due to the surgery.
Nausea and Vomiting Risk Scale: Apfel Score Risk Factors: Female; Smoking habit; History of postoperative nausea and vomiting or motion sickness; Use of opioid painkillers post-surgery (Each risk factor scores 1 point; minimum score is 0; maximum score is 4) Score Probability of Postoperative Nausea and Vomiting 0 - 10% 1. \- 21% 2. \- 39% 3. \- 61% 4. \- 79%
ASA I: A normal, healthy patient with no systemic disease. ASA II: A patient with mild systemic disease. ASA III: A patient with severe systemic disease that limits activity but is not incapacitating. ASA IV: A patient with severe systemic disease that is a constant threat to life. ASA V: A moribund patient not expected to survive without the operation. This project involves collecting data from adult patients aged 20 to 75 years old who are classified as ASA I to III grade.
The Short Form-36 (SF-36) is a widely used health assessment tool, extensively applied in both research and clinical practice. It is a concise yet comprehensive questionnaire designed to evaluate individuals' health status and quality of life. The SF-36 covers eight different dimensions of health, including physical functioning, bodily pain, general health, vitality, social functioning, emotional health, mental health, and health change. Each dimension is assessed through a series of questions that address aspects such as an individual's capabilities in daily life, symptoms, and emotional states. The SF-36 allows healthcare professionals and researchers to gain insights into a person's health and quality of life across these varied aspects. Additionally, SF-36 has undergone extensive testing and validation, proving to have good reliability and validity.
The World Health Organization Quality of Life questionnaire (WHOQOL-BREF) is a health-related quality of life assessment tool developed by the World Health Organization (WHO). It is designed to evaluate an individual's satisfaction with their life and overall health status. The WHOQOL-BREF is a condensed version of the original WHOQOL-100 questionnaire, intended to reduce the time required to complete it and enhance its applicability.
The BDI-II consists of 21 questions that assess the degree of depression by asking respondents about various depressive symptoms they have experienced. These symptoms include sadness, insomnia or oversleeping, changes in appetite, self-blame, self-disdain, loss of interest in daily activities, and more. Each question has four possible response options, allowing respondents to choose the answer that best fits their feelings. Scoring on the BDI-II ranges from 0 to 63, with higher scores indicating more severe depression. Based on the scores, the severity of a respondent's depression can be classified into different levels, ranging from mild to severe. The purpose of using this scale is to help healthcare professionals assess a patient's depressive symptoms, monitor changes in condition, and evaluate the effectiveness of treatments.
The ERAS Patient Satisfaction Questionnaire (ERAS-PSQ) is a satisfaction survey specifically designed for patients who have undergone treatment following the Enhanced Recovery After Surgery (ERAS) protocols. This questionnaire aims to evaluate the patients' satisfaction and experience with the ERAS approach. Typically, it includes questions about various aspects of their treatment and care, such as pain management, the recovery process, the quality of nursing care, and communication with the medical team. The ERAS-PSQ is an important tool for assessing how well the ERAS protocols are received by patients and for identifying areas for improvement in patient care within the ERAS framework.
The Quality of Recovery-40 (QoR-40) is a widely used questionnaire designed to assess the quality of recovery after surgery. It comprises 40 questions that cover both physical and psychological aspects of a patient's recovery, such as pain, nausea, anxiety, dietary habits, and social functioning. The QoR-40 provides a comprehensive view of a patient's postoperative recovery, encompassing a range of factors crucial to understanding the effectiveness of surgical procedures and the overall patient experience during the recovery phase. This tool is instrumental in evaluating and improving post-surgical care and patient outcomes.
Eligibility Criteria
Pituitary tumors, primarily benign growths, develop in the pituitary gland situated in the sellar region. This gland plays a pivotal role in regulating vital body functions including growth, metabolism, and various hormonal functions. As these tumors enlarge, they may press on adjacent areas and impair the gland's functions, leading to symptoms like headaches, vision issues, and hormonal imbalances. The principal treatment for pituitary tumors is surgery, aiming to excise the tumor from the brain's base. This procedure alleviates pressure on the pituitary gland and nearby structures, aiming to reinstate the gland's normal functionality.
You may qualify if:
- Clinical diagnosis of pituitary tumors
- To sign a written informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 807, Taiwan
Biospecimen
pituitary tumor
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hung-Chen Wang, MD, PhD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2023
First Posted
January 24, 2024
Study Start
December 12, 2023
Primary Completion
November 30, 2024
Study Completion
November 30, 2025
Last Updated
January 24, 2024
Record last verified: 2023-12