Negative versus neutral drainage systems in patients following head and neck surgery- A randomised control study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Immediate postoperative quality of life in neutral and negative suction groups
Study Overview
Brief Summary
Surgical drains are now a routine part of postoperative management in major head and neck surgeries. Based on their mechanism of action, drains are broadly classified into negative pressure (active suction) systems and neutral pressure (passive or gravity-based) systems. While negative suction drains are considered effective in reducing fluid collections, minimising dead space, and possibly decreasing infection risk, their application in complex oral cancer surgeries—where tissue integrity is delicate and direct communication with the aero-digestive tract is common—remains debatable. In surgeries involving communication between the oral cavity and neck, or where only thin tissue layers separate compartments, negative pressure drains may pose risks such as tissue compression, microvascular compromise, and suture line dehiscence. Our study aims to address this gap by comparing postoperative hospital course and outcomes in two groups of patients managed with either negative or neutral drainage systems
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Adult patients with age 18 to 60 years 2 Patients with oral and oropharyngeal malignancies anticipated to have neck communication during resection 3 Parents willing to sign informed consent.
Exclusion Criteria
- •1 Patients with early stage malignancies where oral and oropharyngeal parts will not be communicated with neck 2 Patients with other site malignancies 3 Prior radio or chemotherapy.
Outcomes
Primary Outcomes
Immediate postoperative quality of life in neutral and negative suction groups
Time Frame: drain output will be measured on day 1, 2, 3, 4, 5, 6, 7 and 8 postoperatively
Secondary Outcomes
- Postoperative complications in the negative & neutral suction groups.(will be seen on postoperative day 1, day 8 & day 14)
Investigators
Hitesh Verma
All India Institute of Medical Sciences, New Delhi
