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Comparison of Hearing results after repair of ear drum in ambulatory versus overnight admission in adults

Comparison of hearing results in day case versus overnight admission tympanoplasty in adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015070715496N10
Enrollment
200
Registered
2015-09-17
Start date
2013-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tympanoplasty. Perforation of tympanic membrane

Interventions

Intervention 1: Day case Tympanoplasty surgery in intervention group. day-case surgery in this study means discharge the patients within 8 hours after surgery. Intervention 2: Routin Tympanoplasty s
Treatment - Surgery
Day case Tympanoplasty surgery in intervention group. day-case surgery in this study means discharge the patients within 8 hours after surgery.
Routin Tympanoplasty surgery in control group

Sponsors

Vice Chancellor for Research, Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria for day-case surgery group: all patients more than 18 years old who have indication of tympanoplasty; availability to telephone or cellphone; patients dwell inside Shiraz; availability of personal car; care of patients by their family at home; sign of consent form; low anesthesia risk score (score=1); having discharge criteria included: The patients who are awake and alert with stable vital signs, Cases who are mobile, could tolerate fluids; educated patients or their family (high school or more than high school; tympanic perforation =50 % Inclusion criteria for overnight admission group: all patients more than 18 years old who have indication of tympanoplasty; tympanic perforation =50 % Exclusion criteria for day-case surgery group: pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder, immune system deficiency and chronic liver or renal disease.; do not have someone for care of patients at home.; patients dwell outside shiraz; intraoperative complications such as iathrogenic facial nerve truma, iathrogenic displacement of stapes, labirynthin fistula, dural tearing and CSF leakage.; Patient with recurrent emesis, vertigo and uncontrolled pain, not relieved by oral acetaminophen; revision tympanoplasty; Smoker patients; Patients with preoperative mixed hearing loss; Patients with contra-lateral ear disease.; presence of cholestatoma ; presence of tympanosclelerotic plaque in middle ear; presence of granulation tissue in middle ear Exclusion criteria for overnight admission group: pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder, immune system deficiency and chronic liver or renal disease; Smoker patients; Patients with revision surgery; Patients with preoperative mixed hearing loss; Patients with contra-lateral ear disease; presence of cholestatoma; presence of tympanosclelerotic plaque in middle ear; presence of granulation tissue in middle ear

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hearing threshold. Timepoint: before operation - 6 months after operation. Method of measurement: pure tone audiometry.;Postoperative nausea and vomiting (PONV). Timepoint: 24 hours postoperatively. Method of measurement: Observation by trained nurse staff in overnight admission group - selfreport by payients in day-case group.;Postoperative pain. Timepoint: 24 hours postoperatively. Method of measurement: Visual Analog Scale (VAS).;Tympanic membarane graft succsess rate. Timepoint: 6 months after operation. Method of measurement: Observation by surgeon.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSareh Roosta

Center for Development of Clinical Studies, Vice Chancellery of Research and Technology, Shiraz Univ

Roosta.Sareh@gmail.com+98 71 3612 5323

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026