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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 canal wall down tympanomastoidectomy in adults

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015080815496N14
Enrollment
200
Registered
2016-07-21
Start date
2011-03-21
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

Tympanomastoidectomy. Chronic tubotympanic suppurative otitis media,Chronic atticoantral suppurative otitis media,Other chronic suppurative otitis media,Suppurative otitis media, unspecified

Interventions

Intervention 1: Intervention group: Patients underwent canal wall down tympanomastoidectomy and discharge within 8 hours after surgery (day-case discharge). Intervention 2: Control group: Patients und
Treatment - Surgery
Intervention group: Patients underwent canal wall down tympanomastoidectomy and discharge within 8 hours after surgery (day-case discharge).
Control group: Patients underwent canal wall down tympanomastoidectomy and discharge routinely, 24 hours after surgery.

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: patients more than 18 years old who have indication of canal wall down tympanomastoidectomy; availability to telephone or cell phone; patients dwell inside shiraz; availability of personal car; care of patients by their family at home; sign of consent form; low anesthesia risk (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%. Exclusion criteria: 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 acetaminophen; revision surgery; Smoker patients; Patients with preoperative mixed hearing loss; Patients with contra-lateral ear disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Postoperative nausea and vomiting (PONV). Timepoint: every 4 hours for 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: within 24 hours postoperatively ( 2, 4, 8, 16 & 24 Hours after operation). Method of measurement: Visual Analog Scale (VAS).

Secondary

MeasureTime frame
Tympanic membrane graft success rate. Timepoint: 6 months after operation. Method of measurement: Observation by surgeon.;Hearing threshold. Timepoint: before operation - 6 months after operation. Method of measurement: pure tone audiometry.

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