Pituitary AdenomaNCT07618949
Standardized Patient Education in Pituitary Surgery
A study testing Standardized Pituitary Training in people with Pituitary Adenoma, run by Uludag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Standardized Pituitary Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Standardized Patient Education on Patient Outcomes in Transsphenoidal Pituitary Surgery
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.
- Conditions
- Pituitary Adenoma
- Being tested
- Standardized Pituitary Training
- Keywords
- Pituitary tumor, transsphenoidal surgery, Patient education
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Pituitary TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total time from admission to discharge for patients who received standardized patient education in transsphenoidal pituitary surgery
Measured: "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.
Measured: From the registration phase through to the end of the 52-week training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AKİF BULUT, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618949
- Sponsor's protocol ID
- 2026-8/11
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Standardized Patient Education on Patient Outcomes in Transsphenoidal Pituitary Surgery
- ClinicalTrials.gov ID
- NCT07618949
- Acronym / sponsor ID
- 2026-8/11
- Conditions
- Pituitary Adenoma
- Keywords
- Pituitary tumor, transsphenoidal surgery, Patient education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education group | Active comparator | Other: Standardized Pituitary TrainingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Pituitary TrainingThe 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 | Education group |
Primary outcome
The total time from admission to discharge for patients who received standardized patient education in transsphenoidal pituitary surgery
Time frame: "From the registration phase through to the end of the 52-week training program"
1 secondary outcome
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.
Time frame: From the registration phase through to the end of the 52-week training program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Pituitary Training in people with Pituitary Adenoma, run by Uludag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AKİF BULUT, PhD (+905468722872, akifblt23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total time from admission to discharge for patients who received standardized patient education in transsphenoidal pituitary surgery (time frame: "From the registration phase through to the end of the 52-week training program"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.