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Clinical Trials/NCT06221020
NCT06221020
Recruiting
N/A

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

Chang Gung Memorial Hospital1 site in 1 country70 target enrollmentDecember 12, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Enhanced Recovery After Surgery
Sponsor
Chang Gung Memorial Hospital
Enrollment
70
Locations
1
Primary Endpoint
Postoperative pain assessment
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2023
End Date
November 30, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

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

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.

Surgical complications

Time Frame: three months after operation

any complications associated with this operation

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

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.

Readmission within 30 days

Time Frame: within 30 days related to this surgery.

Readmission within 30 days related to this surgery.

Secondary Outcomes

  • Psychological stress- QoR-40(through study completion, an average of 1 year)
  • Quality of life: WHOQOL-BREF(through study completion, an average of 1 year)
  • Psychological stress- BDI-II(through study completion, an average of 1 year)
  • Quality of life: Short Form-36(through study completion, an average of 1 year)
  • ERAS Patient Satisfaction Questionnaire(through study completion, an average of 1 year)

Study Sites (1)

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