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NCT Number: NCT06221020

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Malnutrition Universal Screening Tool

Diagnostic Test

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.

TIB Olfactory Test Device

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.

Apfel Score for Postoperative nausea and vomiting

Diagnostic Test

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

Diagnostic Test

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.

Short Form-36

Behavioral

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)

Behavioral

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)

Behavioral

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)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Surgical complications

    Time frame: three months after operation

    any complications associated with this operation

  2. Postoperative pain assessment

    Time frame: During the hospitalization period, up to 24 weeks

    describe postoperative Visual analogue scale (VAS) for pain assessment; the minimum value is 0 (no pain) and maximum value is 10 (most pain)

  3. Postoperative vomiting assessment

    Time frame: During the postoperative period, up to 7 days

    describe postoperative vomiting status; 0=no; 1=mild, 2=moderate, 3=severe

  4. Postoperative nausea assessment

    Time frame: During the postoperative period, up to 7 days

    describe postoperative nausea status; 0=no; 1=mild, 2=moderate, 3=severe

  5. Reoperation during hospitalization

    Time frame: During the hospitalization period, the time from the first surgery to the reoperation is related to this surgical procedure, assessment up to 12 weeks.

    Reoperation during hospitalization related to this surgery.

  6. Length of hospital stay

    Time frame: The duration from the day of admission to the day of discharge, which is associated with this surgical procedure, assessment up to 12 weeks.

    days of hospitalization related to this surgery.

  7. Readmission within 30 days

    Time frame: within 30 days related to this surgery.

    Readmission within 30 days related to this surgery.

Secondary outcomes

  1. Psychological stress- BDI-II

    Time frame: through study completion, an average of 1 year

    using Beck Depression Inventory-II, assessment of Psychological stress before and after surgery

  2. Psychological stress- QoR-40

    Time frame: through study completion, an average of 1 year

    using Quality of Recovery-40, assessment of Psychological stress before and after surgery

  3. Quality of life: Short Form-36

    Time frame: through study completion, an average of 1 year

    assessment of Quality of life before and after surgery

  4. Quality of life: WHOQOL-BREF

    Time frame: through study completion, an average of 1 year

    assessment of Quality of life before and after surgery

  5. ERAS Patient Satisfaction Questionnaire

    Time frame: through study completion, an average of 1 year

    assessment of Patient Satisfaction for this study

Study contacts

Contact information is provided by the study sponsor or research team.

Hung-Chen Wang, MD, PhD

CONTACT

[email protected]

+886-975056287

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2024
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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