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

Recruiting

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

• Registration Number: NCT06221020
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study Start: 2023-12-12
• Study First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative pain assessment	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)
Postoperative vomiting assessment	During the postoperative period, up to 7 days	describe postoperative vomiting status; 0=no; 1=mild, 2=moderate, 3=severe
Length of hospital stay	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.
Surgical complications	three months after operation	any complications associated with this operation
Postoperative nausea assessment	During the postoperative period, up to 7 days	describe postoperative nausea status; 0=no; 1=mild, 2=moderate, 3=severe
Reoperation during hospitalization	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.
Readmission within 30 days	within 30 days related to this surgery.	Readmission within 30 days related to this surgery.

Secondary Outcome Measures

Name	Time	Method
ERAS Patient Satisfaction Questionnaire	through study completion, an average of 1 year	assessment of Patient Satisfaction for this study
Psychological stress- QoR-40	through study completion, an average of 1 year	using Quality of Recovery-40, assessment of Psychological stress before and after surgery
Quality of life: WHOQOL-BREF	through study completion, an average of 1 year	assessment of Quality of life before and after surgery
Psychological stress- BDI-II	through study completion, an average of 1 year	using Beck Depression Inventory-II, assessment of Psychological stress before and after surgery
Quality of life: Short Form-36	through study completion, an average of 1 year	assessment of Quality of life before and after surgery

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan