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A Prospective, Randomized, Multicenter Non-Inferiority Trial Evaluating the Safety of Parotidectomy Without Active Surgical Drainage (Svenska Nationella Parotisstudien)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study The purpose of this study is to find out if it is safe to perform surgery on the parotid gland (the large salivary gland in front of the ear) without using a wound drain. A wound drain is a small plastic tube used to remove excess fluid from the surgical site after the operation. Currently, using a drain is the standard practice in Sweden, which often means patients must stay in hospital overnight. Researchers want to see if skipping the drain is just as safe and if it could allow more patients to return home on the same day as their surgery. What happens during the study Participants in this study will be randomly assigned to one of two groups during their surgery: Group 1: Will receive the standard treatment with a wound drain. Group 2: Will have the surgery performed without a wound drain. Apart from the use of a drain, all participants will receive the same surgical care. After the operation, researchers will monitor the healing process. Participants will be asked to fill out questionnaires about their health and any symptoms at one week and six months after their surgery. The goal of the study The main goal is to compare the safety of the two methods. Researchers will look at whether there is any difference in the number of complications, such as fluid build-up (seroma), bleeding, or infections, between those who had a drain and those who did not. The study also aims to evaluate if avoiding a drain improves the patient's quality of life and if it is a more cost-effective approach for the healthcare system.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients scheduled to undergo partial or superficial parotidectomy without concurrent soft tissue surgery, in cases where a wound drain is traditionally used (extirpation of single adjacent lymph nodes is acceptable).

• ASA physical status class 1-3.

• Aged 18 years or older.

• The patient understands the participant information and is able to make an informed choice.

Locations
Other Locations
Sweden
Karolinska university hospital
RECRUITING
Stockholm
NÄL
RECRUITING
Trollhättan
Uppsala University Hospital, Department of Otorhinolaryngology
RECRUITING
Uppsala
Contact Information
Primary
Karl Sandström, MD, PhD
karl.sandstrom@akademiska.se
+46 76 113 29 52
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2032-12
Participants
Target number of participants: 600
Treatments
Experimental: Drainless Group (Intervention)
Participants in this group will undergo partial or superficial parotidectomy without the placement of a postoperative active wound drain. The surgical site is closed according to the standard technique, but the suction drain is omitted.
Active_comparator: Standard Drain Group (Control)
Participants in this group will undergo partial or superficial parotidectomy with the placement of a postoperative active wound drain, according to current standard clinical routine in Sweden.
Related Therapeutic Areas
Sponsors
Collaborators: Västra Götalandsregionen, Uppsala University, Göteborg University
Leads: Uppsala University Hospital

This content was sourced from clinicaltrials.gov

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