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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 20 to 75 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Enhanced Recovery After Surgery, Pituitary Tumor, Postoperative Complications

Being tested

Malnutrition Universal Screening Tool, TIB Olfactory Test Device, Apfel Score for Postoperative nausea and vomiting, The American Society of Anesthesiologists (ASA) Physical Status Classification, Short Form-36

Keywords

Enhanced Recovery After Surgery, Pituitary tumor, Anesthesia Safety, Postoperative Complications

Medical subject headings

Pituitary Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Malnutrition Universal Screening ToolDiagnostic 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 DeviceDevice

  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 vomitingDiagnostic 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%

  1. - 21%
  2. - 39%
  3. - 61%
  4. - 79%

• The American Society of Anesthesiologists (ASA) Physical Status ClassificationDiagnostic 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-36Behavioural

  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)Behavioural

  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)Behavioural

  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)Behavioural

  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)Behavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Surgical complications

   any complications associated with this operation

   Measured: three months after operation

2. 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)

   Measured: During the hospitalization period, up to 24 weeks

3. Postoperative vomiting assessment

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

   Measured: During the postoperative period, up to 7 days

4. Postoperative nausea assessment

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

   Measured: During the postoperative period, up to 7 days

5. Reoperation during hospitalization

   Reoperation during hospitalization related to this surgery.

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

6. Length of hospital stay

   days of hospitalization related to this surgery.

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

7. Readmission within 30 days

   Readmission within 30 days related to this surgery.

   Measured: within 30 days related to this surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Jan 2024
2. Study start12 Dec 2023
3. Primary completion30 Nov 2026 (estimated)
4. Study completion30 Nov 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.