Clinical trial NCT06221020: To Assess the Impact of theERAS Consensus on Patients With Endoscopic Pituitary Tumor Surgery
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Enhanced Recovery After Surgery
Pituitary Tumor
Postoperative Complications
Keywords: Enhanced Recovery After Surgery
Pituitary tumor
Anesthesia Safety
Postoperative Complications
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Surgical complications
timeFrame: three months after operation
measure: Postoperative pain assessment
timeFrame: During the hospitalization period, up to 24 weeks
measure: Postoperative vomiting assessment
timeFrame: During the postoperative period, up to 7 days
measure: Postoperative nausea assessment
timeFrame: During the postoperative period, up to 7 days
measure: Reoperation during hospitalization
timeFrame: During the hospitalization period, the time from the first surgery to the reoperation is related to this surgical procedure, assessment up to 12 weeks.
measure: Length of hospital stay
timeFrame: The duration from the day of admission to the day of discharge, which is associated with this surgical procedure, assessment up to 12 weeks.
measure: Readmission within 30 days
timeFrame: within 30 days related to this surgery.
Secondary outcomes:
measure: Psychological stress- BDI-II
timeFrame: through study completion, an average of 1 year
measure: Psychological stress- QoR-40
timeFrame: through study completion, an average of 1 year
measure: Quality of life: Short Form-36
timeFrame: through study completion, an average of 1 year
measure: Quality of life: WHOQOL-BREF
timeFrame: through study completion, an average of 1 year
measure: ERAS Patient Satisfaction Questionnaire
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hung-Chen Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: