Neoplasms

All Conditions

Symptoms and General Pathology

Head and Neck Neoplasms

Ischemia

Intervention is remote ischemic preconditioning (RIPC) consists of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) and subsequent 5-min reperfusion applied to upper arm.

Intervention is Sham-RIPC (ischemia pressure \< 10 mmHg) applied to upper arm.

remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm

remote ischemic preconditioning (RIPC)

ischemia pressure less than 10 mmHg (sham-RIPC)

sham-RIPC

Youn Joung Cho, MD, PhD

Remote ischemic preconditioning (RIPC) has been revealed organ-protective effect in many previous clinical settings including coronary intervention or cardiovascular surgery. However its protective role during free flap reconstructive surgery in head and neck cancer patients has not yet been elucidated. The purpose of the current study is to evaluate the effect of RIPC on tissue oxygen saturation and skin temperature of the flap, as well as its organ-protective effect using Langendorff isolated heart ischemia-reperfusion model.

Patients undergoing free flap reconstructive surgery for head and neck cancer will be randomized to either remote ischemic preconditioning (RIPC) group or control group. On the day of surgery, after induction of anesthesia, RIPC, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) followed by 5-min reperfusion at upper arm, or sham-RIPC (pressure \< 10 mmHg) will be induced in the RIPC or control group, respectively. Before completion of surgery, RIPC or sham-RIPC will be repeated. Tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1.

As a sub-study, blood samples will be obtained before and after RIPC/sham-RIPC. From them, plasma dialysate will be prepared to use for Langendorff isolated heart model. Myocardial infarct size of Langendorff rat heart will be compared between the groups to evaluate organ protective effect of RIPC during free flap reconstuctive surgery.

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients: a Randomized Controlled Trial

Seoul National University Hospital

Clinical assistant professor

Heart and Blood Diseases

Reperfusion Injury

Vascular Diseases

Postoperative Complications

Remote ischemic preconditioning (RIPC) consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the RIPC group.

Sham-RIPC consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the Sham-RIPC group.

RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.

Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion.

Sham-RIPC

Youn Joung Cho, MD

Remote ischemic preconditioning (RIPC) has shown organ-protective effects in many clinical settings including patients with ischemic heart disease. However its protective role in head and neck cancer patients with preoperative radiotherapy undergoing free flap reconstructive surgery has not yet been evaluated. The purpose of the current study is to evaluate the effect of RIPC on tissue oxygen saturation and skin temperature of the flap.

Patients undergoing free flap reconstructive surgery for head and neck cancer with preoperative radiotherapy will be randomized to either remote ischemic preconditioning (RIPC) group or control group. On the day of surgery, after induction of anesthesia, RIPC, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) followed by 5-min reperfusion at the upper arm, or sham-RIPC (pressure \< 10 mmHg) will be induced in the RIPC or control group, respectively. Before completion of surgery, RIPC or sham-RIPC will be repeated. Tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1.

RIPC During Free Flap With Preoperative Radiotherapy

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy

skin temperature of the flap and the adjacent tissue

Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017

Patients who underwent ALT free flap reconstruction after head and neck cancer surgery.

ALT flap reconstruction

Patients who underwent AMT free flap reconstruction after head and neck cancer surgery.

AMT flap reconstruction

This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer reconstruction.

To compare the results of the AMT and ALT flaps, this study aimed to compare their outcomes in head and neck cancer reconstruction under the condition of attenuating baseline patient and operative characteristics with the selection of propensity score-matched patient cohorts.

Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer

Comparison of the Outcome of Choosing Free Anterolateral Thigh or Free Posterolateral Thigh Flap for Reconstruction in Patients With Head and Neck Cancer

The primary free flap outcome was determined as its survival or failure.

The second outcome was the associated complications (fistula, hematoma, partial necrosis, and wound infection).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction	NCT03474952	Remote Ischemic...	remote ischemic... sham-RIPC	20 Years -	Seoul National University Hospital
RIPC During Free Flap With Preoperative Radiotherapy	NCT03535623	Ischemic Reperf... Other Reconstru... Radiotherapy	remote ischemic... Sham-RIPC	20 Years -	Seoul National University Hospital
Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer	NCT04002713	Reconstructive ... Head and Neck C...	ALT flap recons... AMT flap recons...	20 Years - 100 Years	Chang Gung Memorial Hospital
Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer	NCT04002713	Reconstructive ... Head and Neck C...	ALT flap recons... AMT flap recons...	20 Years - 100 Years	Chang Gung Memorial Hospital

Spots Global Cancer Trial Database for free flap reconstruction