NCT07618949

Brief Summary

Protocols are being developed and implemented to ensure the best possible recovery process for patients undergoing transsphenoidal surgery, and their impact on patient outcomes is being evaluated. In studies where perioperative protocols-including patient education (verbal and written instruction on dehydration, hyponatremia, adrenal insufficiency, CSF leakage, meningitis, and the signs and symptoms of visual or other neurological disorders)-are implemented, it has been reported that patients' length of hospital stay is reduced, the rate of patients experiencing hyponatremia has decreased, and readmissions have declined (Sanchez-Garavito et al., 2024; Sarris et al., 2021). However, since these studies included protocols covering the entire surgical process-not just patient education-it is difficult to determine whether changes in patient outcomes stem from patient education or from alterations in other parameters within the protocol. Therefore, in the clinic where this study will be conducted, the effect of patient education on postoperative patient outcomes will be examined by developing an educational material that standardizes patient education, without making any changes to the surgical or pharmacological processes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Sep 2027

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 24, 2026

Last Update Submit

May 24, 2026

Conditions

Keywords

Pituitary tumortranssphenoidal surgeryPatient education

Outcome Measures

Primary Outcomes (1)

  • The total time from admission to discharge for patients who received standardized patient education in transsphenoidal pituitary surgery

    "From the registration phase through to the end of the 52-week training program"

Secondary Outcomes (1)

  • Complication rates (meningitis, hyponatremia, CSF leak) and rates of unplanned readmission among patients who received standardized training in transsphenoidal pituitary surgery during their hospital stay.

    From the registration phase through to the end of the 52-week training program

Study Arms (2)

Education group

ACTIVE COMPARATOR

The standardized educational material to be used with the training group was developed by the researchers through a literature review and includes evidence-based recommendations that patients should follow after pituitary surgery. The educational material and the sources used to create it are included in the appendix. Before providing education to patients in the intervention group, nurses and resident physicians working in neurosurgery will receive in-person training on the rationale and details of the material. Patients will be included in the education program starting from their preoperative hospital admission; the content of the educational material will be explained by a nurse, and a visual copy will be provided to both the patient and their caregiver. Additionally, the material will be posted in a clearly visible location in the patient's room.

Other: Standardized Pituitary Training

Control group

NO INTERVENTION

The control group for this study will consist of former patients who underwent pituitary surgery at the Neurosurgery Clinic prior to the start of this scientific study. Routine post-operative care at the clinic following pituitary surgery is as follows: patients who have undergone pituitary surgery are provided with information about the surgical process by the attending physician prior to surgery, and their voluntary written consent is obtained. After surgery, the physician, resident, and nurse provide verbal instructions to the patient regarding constipation and precautions related to the nose; however, no standardized written educational materials are used.

Interventions

The standardized educational material to be used with the training group was developed by the researchers through a literature review and includes evidence-based recommendations that patients should follow after pituitary surgery. The educational material and the sources used to create it are included in the appendix. Before providing education to patients in the intervention group, nurses and resident physicians working in neurosurgery will receive in-person training on the rationale and details of the material. Patients will be included in the education program starting from their preoperative hospital admission; the content of the educational material will be explained by a nurse, and a visual copy will be provided to both the patient and their caregiver. Additionally, the material will be posted in a clearly visible location in the patient's room.

Education group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted for elective surgery due to a pituitary tumor.
  • Has not previously undergone surgery for the same medical condition.
  • Has voluntarily agreed to participate in the study.
  • Has no missing medical data.
  • Can speak Turkish or understand what is being explained.
  • Patients aged 18 and older.

You may not qualify if:

  • Emergency surgery will be performed.
  • Revision surgery will be performed.
  • Those who voluntarily decline to participate in the study.
  • Those with incomplete medical data.
  • Those who cannot speak or understand Turkish.
  • Patients under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Central Study Contacts

AKİF BULUT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Due to the ethics committee's decision regarding the conduct of the study, the data will not be publicly disclosed. However, the data will be shared if a reasonable justification is provided.