Determining the Effect of Education Given to Patients Undergoing Outpatient Anal Fistula Surgery

NCT07323160 | Not Yet Recruiting

• 1 other identifier: MSKU Ethics Committe No:250098
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is emphasized that discharge education should shift from traditional healthcare provider-centered, one-way education to patient-centered education based on patient-care provider interaction to ensure patients' active participation in their own care, adherence to the recommended treatment plan, and maintenance of surgical success after outpatient anal fistula surgery. In this context, it is suggested that an effective education method such as teach-back can be used in clinical settings to teach patients complex health information and facilitate their understanding of discharge education. While studies exist in the literature evaluating the impact of health literacy after general surgery, no studies have been found specifically evaluating health literacy and discharge education for anal fistula surgery. Furthermore, it is emphasized that further research is needed to improve the quality of postoperative care after anal fistula surgery and to better understand the factors contributing to unplanned hospital returns. Based on this need, this study is a randomized controlled trial with a pretest and posttest approach aimed at determining the effect of teach-back-based discharge education on hospital readmission and patient satisfaction in outpatient anal fistula surgery patients. The study sample was calculated as a total of 68 people, 34 in each group, based on a power analysis performed with the GPower 3.1. 9.7 program, using a type 1 error of 0.05, a type 2 error of 0.20, and an effect size of 0.70 to determine the difference in measurements between the groups. Considering the possible attrition in the study, the sample size was increased by 10%, and a total of 76 people, 38 in each group, were planned to be included in the study. Following Ethics Committee approval and institutional permissions, the study data will be collected using the Individual Identification Form, Health Literacy Scale, Anal Fistula Surgery Discharge Education Knowledge Test, Discharge Satisfaction Scale, and Post-Discharge Follow-up Form, from patients scheduled for and undergoing outpatient anal fistula surgery at Muğla Training and Research Hospital between November 15, 2025, and January 30, 2027. The research will be conducted in three phases: the development of the education brochure and knowledge test, and the preoperative and postoperative phases. The "Anal Fistula Surgery Discharge Education Knowledge Test" was developed to assess patients' knowledge of anal fistula and its care. The "Anal Fistula Surgery Discharge Education Patient Booklet" was developed by the researchers using literature review and consultation with a General Surgery Specialist specializing in anal fistulas to provide specific training on anal fistula surgery and postoperative care. These were then sent to specialists for expert opinion. All patients presenting to the General Surgery Outpatient Clinic for anal fistula surgery who meet the inclusion criteria will be interviewed face-to-face before surgery to be informed about the study. Patients who agree to participate will be asked to sign a consent form. Because outpatient surgeries involve admission and discharge within 24 hours, and patients arrive at the Proctology Unit on the day of surgery, all patients will be summoned to the General Surgery Outpatient Clinic the day before surgery and will complete the "Individual Identification Form," "Health Literacy Scale," and "Anal Fistula Surgery Discharge Education Knowledge Test." Patients will be assigned to the intervention (discharge education via teach-back) and control groups using a block randomization table based on their order of admission to the Proctology Unit for the surgical procedure. Patients in the intervention group will receive discharge education via teach-back using the "Anal Fistula Surgery Discharge Education Patient Booklet." Education will continue until the patient accurately recounts the information to the principal investigator and is confident that the patient has understood the instruction correctly. The control group will receive standard patient education in the clinic and will not receive any intervention. Postoperatively, all patients in both groups will complete the "Anal Fistula Surgery Discharge Education Knowledge Test" post-test and the Discharge Education Satisfaction Scale before being discharged from the unit. Patients in both groups will be contacted weekly for 30 days to monitor their progress. Because the study will provide training, blinding of the assessments will not be possible.

Conditions

Anal Fistula; Patient Discharge Education; Outpatient Anal Surgery

Keywords

Anal fistula, Day surgery, Discharge teaching, Patient satisfaction, Readmission

Outcome Measures

Primary Outcomes (2)

• Effect of teach-back discharge education on postoperative readmission and patient satisfaction

  The rate of hospital readmissions within the follow-up period and the mean patient satisfaction scores will be compared between the teach-back discharge education group and the routine discharge education group to evaluate the effect of the intervention.

  Within 30 days after surgery

• Discharge Education Satisfaction Scale

  Discharge Education Satisfaction Scale (TEMÖ): It was developed by Meşe and Köşgeroğlu in 2018 to determine the satisfaction of patients or their relatives who underwent surgical intervention with discharge education. The scale items include 21 items related to the discharge process, home care, medication, pain, infection, exercise, and postoperative follow-up. The minimum score that can be obtained from the scale is 21, and the maximum score is 105. TEMÖ is a 5-point Likert-type scale, and the scale items are scored as "completely satisfied" (5), "satisfied" (4), "partially satisfied" (3), "not satisfied" (2), and "not satisfied at all" (1). The scale has no cut-off point, and higher scores indicate higher satisfaction with discharge education. The Cronbach's alpha coefficient was 0.91 in the original scale, and total item correlation scores were found to range between 0.42 and 0.64 (Meşe, 2018). Permission was obtained from Sevinç Meşe for the use of the scale in the study.

  within 30 days after surgery

Study Arms (2)

Teach-back discharge education

EXPERIMENTAL

Participants receive discharge education using the teach-back method.

Behavioral: Teach-back discharge education

Routine discharge education

NO INTERVENTION

Participants receive routine discharge education.

Interventions

Teach-back discharge education BEHAVIORAL

For the Experimental Group: Intervention Name: Teach-back discharge education Intervention Type: Behavioral Description: Discharge education provided using the teach-back method. For the Control Group: Intervention Name: Routine discharge education Intervention Type: Behavioral Description: Standard discharge education provided without teach-back.

Teach-back discharge education

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a day surgery planned, Being admitted to the Proctology Unit for anal fistula surgery, Being undergoing elective anal fistula surgery for the first time, Being planned to have a surgical procedure performed with local anesthesia, Being over 18 years of age, Being able to read and understand Turkish, Being able to read and understand the research instructions, Being literate, Agreeing to participate in the research.

You may not qualify if:

• Having surgery planned with general anesthesia, Requiring general anesthesia during the surgical procedure, Being hospitalized for more than 24 hours, Having a recurrent anal fistula, Having another anorectal disease besides the anal fistula, such as advanced Crohn's disease or colorectal cancer, Having complications within 24 hours of surgery and rescheduling surgery, Having visual, auditory, or cognitive problems, Having agreed to participate in the study but wishing to withdraw during follow-up.

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

MeSH Terms

Conditions

Rectal Fistula; Patient Satisfaction

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Cemile Yaşar, Nurse

CONTACT

+905530954397; cemileyasar720@gmail.com

Gülşah Köse, Associate professor

CONTACT

+905333829280; gulsahkose@mu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: surgical Nurse

Model Details: Two parallel groups: teach-back discharge education vs. routine discharge education.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 7, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share