Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial (RIPC-HNC)

Aarhus University Hospital Skejby

Status: Completed

Conditions: Head and Neck Neoplasms

Treatments: Procedure: Sham; Procedure: Remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02548377

RIPC-HNC

Details and patient eligibility

About

The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the risk of complications in patients undergoing resection of head and neck cancer and immediate reconstruction with autologous free tissue transfer.

Remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet.

Blood samples will be taken during the operation and postoperatively to evaluate the effects of remote ischemic preconditioning. These blood samples will be analyzed for clotting properties and markers of inflammation.

Furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography.

Effects on surgical complication rates will be obtained by clinical follow-up and patient chart review.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically verified or clinically suspected malignant tumor in the oral cavity, maxillae, mandible, pharynx, larynx, and/or esophagus.
• Will undergo tumor resection and immediate free flap reconstruction at Aarhus University Hospital, Denmark.
• The reconstruction is planned with a single free flap.

Exclusion criteria

• Arterial and/or venous thromboembolism within the last three months.
• The reconstruction is planned with more than one free flap.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Remote ischemic preconditioning

Experimental group

Description:

Four 5-minute cycles of upper extremity ischemia, each separated by five minutes of reperfusion. The treatment will be carried out with a tourniquet inflated to 200 mmHg during general anaesthesia prior to flap ischemia and transfer.

Treatment:

Procedure: Remote ischemic preconditioning

Sham

Sham Comparator group

Description:

The tourniquet will be attached to the patient's upper extremity but never inflated.

Treatment:

Procedure: Sham