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

Postoperative Complications Clinical Trial

Official title:

To Assess the Impact of the Enhanced Recovery After Surgery (ERAS) Consensus on the Effectiveness and Prognosis of Patients With Endoscopic Pituitary Tumor Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221020
• Other study ID #: 202300876B0A3
• Status: Recruiting
• Start date: December 12, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: December 2023
• Source: Chang Gung Memorial Hospital
• Contact: Hung-Chen Wang, MD, PhD
• Phone: +886-975056287
• Email: m82whc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor
• Postoperative Complications

Intervention

Diagnostic Test:
• Malnutrition Universal Screening Tool
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.

Device:
• TIB Olfactory Test Device
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.

Diagnostic Test:
• Apfel Score for Postoperative nausea and vomiting
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% - 21% - 39% - 61% - 79%
• The American Society of Anesthesiologists (ASA) Physical Status Classification
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.

Behavioral:
• Short Form-36
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.
• World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
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.
• BDI-II(Beck Depression Inventory-II)
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.
• ERAS Patient Satisfaction Questionnaire(ERAS-PSQ)
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.
• Quality of Recovery-40(QoR-40)
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical complications	any complications associated with this operation	three months after operation
Primary	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
Primary	Postoperative vomiting assessment	describe postoperative vomiting status; 0=no; 1=mild, 2=moderate, 3=severe	During the postoperative period, up to 7 days
Primary	Postoperative nausea assessment	describe postoperative nausea status; 0=no; 1=mild, 2=moderate, 3=severe	During the postoperative period, up to 7 days
Primary	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.
Primary	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.
Primary	Readmission within 30 days	Readmission within 30 days related to this surgery.	within 30 days related to this surgery.
Secondary	Psychological stress- BDI-II	using Beck Depression Inventory-II, assessment of Psychological stress before and after surgery	through study completion, an average of 1 year
Secondary	Psychological stress- QoR-40	using Quality of Recovery-40, assessment of Psychological stress before and after surgery	through study completion, an average of 1 year
Secondary	Quality of life: Short Form-36	assessment of Quality of life before and after surgery	through study completion, an average of 1 year
Secondary	Quality of life: WHOQOL-BREF	assessment of Quality of life before and after surgery	through study completion, an average of 1 year
Secondary	ERAS Patient Satisfaction Questionnaire	assessment of Patient Satisfaction for this study	through study completion, an average of 1 year