Evaluation of postoperative complications and length of hospital stay in patients with and without drain placement
Design
This is a phase II, randomized, controlled clinical trial involving 70 patients. Participants are allocated to study groups using a simple randomization method.
Settings and conduct
This study is conducted on patients undergoing superficial parotidectomy at this hospital, and postoperative complications are monitored during the follow-up period.
Participants/Inclusion and exclusion criteria
Participants include patients diagnosed with benign parotid neoplasm who candidates for superficial parotidectomy.
Exclusion criteria consist of patients with malignant parotid tumors and those with underlying coagulation disorders.
Intervention groups
The intervention group consists of patients who undergoing superficial parotidectomy without drain placement, whereas the control group consists of patients who undergoing superficial parotidectomy with drain placement.
Main outcome variables
The primary outcome is the rate of postoperative surgical site complications (hematoma, seroma, and infection) within the first 60 days post-surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260511069350N1
Registration date:2026-05-25, 1405/03/04
Registration timing:registered_while_recruiting
Last update:2026-05-25, 1405/03/04
Update count:0
Registration date
2026-05-25, 1405/03/04
Registrant information
Name
Rezvan Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 2768 4226
Email address
salimi.re@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-21, 1405/02/31
Expected recruitment end date
2027-05-21, 1406/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Superficial parotidectomy with or without the use of a post-operative drain: A Randomized, Open-label, Phase II Clinical Trial
Public title
Superficial parotidectomy with or without the use of a post-operative drain: A Randomized, Open-label, Phase II Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with benign salivary gland tumors located in the superficial lobe of the parotid gland
Exclusion criteria:
malignant tumor
Hemostatic disorders
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was performed using a random numbers table to allocate participants to the intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Comparison of the incidence of postoperative complications after superficial parotidectomy for benign parotid neoplasms with versus without drain placement.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The incidence rate of postoperative hematoma
Timepoint
within a 2‑month postoperative period
Method of measurement
The diagnostic criterion is clinical assessment, and ultrasound will be used if necessary.
Secondary outcomes
1
Description
Postoperative seroma formation rate.
Timepoint
within a 2‑month postoperative period
Method of measurement
The diagnostic criterion is clinical assessment, and ultrasound will be used if necessary.
Intervention groups
1
Description
Intervention group: Patients undergoing superficial parotidectomy without drain placement.
Category
Treatment - Surgery
2
Description
Control group: Patients undergoing superficial parotidectomy with drain placement.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information related to the primary outcome and study results.
When the data will become available and for how long
Data access will commence 6 months after publication of the results.
To whom data/document is available
Access will be restricted to researchers affiliated with academic and scientific institutions.
Under which criteria data/document could be used
Data may be used for non-commercial academic research, including secondary analyses and meta-analyses, under a data use agreement ensuring confidentiality and proper citation of the original trial.
From where data/document is obtainable
rezvansalimi805@gmail.com
What processes are involved for a request to access data/document
The request for data use must be submitted in writing, accompanied by a brief research proposal and an analysis plan, to the principal investigator. Following scientific and ethical review and approval, and upon signing a data use agreement, de-identified data will be made available to the applicant within the scope of that agreement.