Standardized Patient Education in Pituitary Surgery
ConditionPituitary Adenoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUludag University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Emergency surgery will be performed.
Revision surgery will be performed.
Those who voluntarily decline to participate in the study.
Those with incomplete medical data.
Trial design
Design model
Parallel
Treatments tested in this trial
Standardized Pituitary Training
Other interventionThe 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Education groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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"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.
Time frame
From the registration phase through to the end of the 52-week training programLocations
Sponsors and contacts
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Uludag University
Lead sponsor
Bursa City Hospital
Sponsor institution
Source ClinicalTrials.gov
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