RIPC During Free Flap With Preoperative Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2024-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

NCT06798922

Oral Cavity Carcinoma Flap Radiotherapy, Adjuvant +1 more

RECRUITING PHASE3

Retrospective Study on the Prediction of Radiation-induced Brain Injury in Patients With Nasopharyngeal Carcinoma

NCT06244394

Nasopharyngeal Carcinoma Radiation-Induced Temporal Lobe Injury

COMPLETED

Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications

NCT02785692

Sarcoma

TERMINATED

Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery

NCT06812052

Retroperitoneal Sarcoma

RECRUITING PHASE1

Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma

NCT03768856

Head and Neck Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Reperfusion Injury Other Reconstructive Surgery Radiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RIPC

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.

Group Type EXPERIMENTAL

remote ischemic preconditioning (RIPC)

Intervention Type OTHER

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

Sham-RIPC

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.

Group Type SHAM_COMPARATOR

Sham-RIPC

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

remote ischemic preconditioning (RIPC)

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

Intervention Type OTHER

Sham-RIPC

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult head and neck cancer patients undergoing free flap reconstructive surgery with preoperative radiotherapy

Exclusion Criteria

* Radiotherapy within 4 weeks
* Body mass index \< 18 kg/m\^2 or \> 35 kg/m\^2
* Presence of AV fistula at the arm, any reason to protect arms
* Presence of vascular abnormality or discomfort at arms
* Peripheral vascular disease, peripheral neuropathy, or coagulopathy
* Uncontrolled diabetes mellitus
* Preoperative use of beta-blockers
* Refuse to enrol

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No