Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery

NCT07620184 | Recruiting

• 1 other identifier: 2025-07555-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Parotid Neoplasms; Post-operative Complications; Seroma as Procedural Complication

Keywords

Parotidectomy; Surgical drainage; Wound drains; Postoperative complications; Seroma; Hematoma; Randomised controlled trial; Non-inferiority; Salivary gland surgery; Quality of life

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of early postoperative complications requiring intervention

  The primary outcome is the number of participants experiencing at least one early complication, defined as a salivary fistula, haematoma, seroma/sialocele, or surgical site infection that requires invasive or medical treatment (e.g., aspiration, re-operation, or antibiotics).

  From the day of surgery up to 7 weeks postoperatively.

Secondary Outcomes (6)

• Requirement for inpatient hospital care after the day of surgery.

  From the first postoperative day up to 6 months

• Postoperative facial nerve function.

  Baseline (preoperative), at discharge, at 7 weeks, and at 6 months

• Incidence of Frey's syndrome

  6 months postoperatively.

• Health-related quality of life (EQ-5D-5L)

  7 weeks, and 6 months postoperatively

• Postoperative length of stay

  Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.

Study Arms (2)

Drainless Group (Intervention)

EXPERIMENTAL

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.

Procedure: Omission of active wound drain

Standard Drain Group (Control)

ACTIVE COMPARATOR

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.

Procedure: Active wound drainage (Standard of Care)

Interventions

Active wound drainage (Standard of Care) PROCEDURE

An active suction drain is placed in the surgical bed before wound closure, which is the current established clinical practice for parotidectomy in Sweden.

Standard Drain Group (Control)

Omission of active wound drain PROCEDURE

The surgical procedure is performed without the insertion of an active suction drain. All other aspects of the surgical care and postoperative monitoring follow standard protocols.

Drainless Group (Intervention)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Previous parotid surgery on the same side
• Tumour with parapharyngeal extension.
• Ongoing or planned perioperative treatment with tranexamic acid.
• Ongoing treatment with anticoagulants (NOAC, Warfarin) at the time of surgery. NOAC must be discontinued at least 24 hours before surgery.
• Ongoing treatment with low molecular weight heparin in doses higher than: Fragmin 5000 IU/day, Clexane 40 mg/day, or Innohep 4500 IU/day.Ongoing treatment for malignancy.Known coagulation disorder.
• Platelet count \<150 x 10⁹
• PK-INR \>1.2.
• Hb \<120 g/L.
• APTT \>42s.
• Preoperative impaired facial nerve function on the affected side (Sunnybrook Facial Grading System score \<90).
• Supplementary postoperative treatment such as radiotherapy or extended surgery.

Sponsors & Collaborators

• Uppsala University: collaborator
• Uppsala University Hospital: lead
• Västra Götalandsregionen: collaborator
• Göteborg University: collaborator

Study Sites (3)

Karolinska university hospital

Stockholm, Sweden

RECRUITING

NÄL

Trollhättan, Sweden

RECRUITING

Uppsala University Hospital, Department of Otorhinolaryngology

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Parotid Neoplasms; Postoperative Complications; Seroma; Hematoma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Hemorrhage

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Karl Sandström, MD, PhD

CONTACT

+46 76 113 29 52; karl.sandstrom@akademiska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associated professor

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 2, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)