Neoplasms

All Conditions

Head and Neck Neoplasms

surveys, evaluative tests for leg function

Alexander Langerman, MD

Anterolateral thigh (ALT) free flap tissue transfer is a commonly used method of head and neck reconstruction after head and neck cancer removal. The procedure involves removing some muscle, skin, and tissue from the thigh, and this may affect leg function. The purpose of this study is to determine the impact of ALT on ambulation and activities of daily living (ADLs)

The ALT flap may be harvested as a subcutaneous, fasciocutaneous, musculocutaneous, or adipofascial flap. At our institution, three surgeons commonly use this method of free tissue transfer to reconstruct such defects. In our experience, patients following harvest of ALT flap have impairments in lower extremity function that result in decreased independence with transfers, gait and ability to independently perform ADLs. Consequently, these patients receive Physical and Occupational Therapy following surgery and a number of patients go on to receive therapy in a rehabilitation facility and/or as an outpatient. A number of studies have examined donor site morbidity and lower extremity function following ALT flap harvest. These studies, however, are heterogeneous and primarily use patient reported and non-standardized scales as outcome measures. Additionally, there is a paucity of literature related to Physical Therapy and Occupational Therapy outcomes and intervention with this patient population, despite frequent referral of these patients for post-surgical therapy.

This investigation will utilize the Lower Extremity Functional Scale, the Functional Independence Measure, dynamometry, video analysis of a single leg squat and walking speed in an effort to better assess the affect of ALT harvesting on patients' functional capacity post operatively. These tests are valid and reliable measures commonly utilized in Physical Rehabilitation.

Leg Function and ADL After ALT Reconstruction for Head and Neck Cancer

Does Harvesting an Anterolateral Thigh (ALT) Flap Impact Lower Extremity Function and Activities of Daily Living (ADL) in Patients Undergoing Reconstructive Surgery for Head and Neck Cancer

The Lower Extremity Functional Scale (LEFS) is a validated self-report measure designed to assess the functional capabilities of patients with any lower extremity related musculoskeletal condition. Subjects will be assessed for a change from pre- to post-operative

Standing on one leg and walking, specifically duration of standing on one leg in minutes and distance walked up to 100 ft. Subjects will be assessed from pre-to-postoperative to determine the decline in leg function.

The Functional Independence Measure (FIM) will assess subject ability to perform activities of daily living such as bathing, lower body dressing, toileting, bed to chair transfer, toilet transfer, walking on level and stairs, social interaction, problem solving and memory. We will assess the change from pre- to post-operative

Dynamometry will be performed in seated position to determine a change in muscle strength from pre- to post-operative

University of Chicago

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Ischemia

Application of CGM for 6 days following free flap reconstruction in conjunction with clinical monitoring

Continuous Glucose Monitor

Edward Liu, MD

Ronen Avram, MD

Jiayi Hu, MD

Achilleas Thoma, MD

Matthew McRae, MD

A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival. In this study, the investigators aim to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.

Background:

Breast reconstruction involving microvascular free tissue transfer is a major, labour-intensive operation that provides numerous benefits for patients' psychosocial function and well-being.

Flap failure, though rare, is a devastating complication and leads to serious morbidities. It can occur in the first 24-72 hours after the operation. However, if ischemia is detected earlier, the chances for operative salvage are better. Unfortunately, the current monitoring process remains mostly subjective.

A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival.

Purpose:

The overall objective of this clinical pilot study is to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.

Methods:

In this pilot cohort study, the investigators aim to prospectively include 30 free flaps in total from 10-20 patients undergoing DIEP-based breast reconstruction by one surgeon at Juravinski Hospital. Patients will be recruited at the pre-operative consultation. The transcutaneous sensor of the CGM device will be inserted into the subcutaneous layer of the flap upon completion of surgery, while an additional sensor will be placed on the patient's thigh as control. These devices are blinded and will start recording the flap's interstitial glucose levels. The patient will be admitted and the flap will be assessed clinically as per protocol. On-call residents will be given a data collection sheet to document the exact time they were alerted about a flap, the clinical finding, and the subsequent decision made. Once an endpoint has been reached for a flap, the CGM sensor will be removed and its data extracted.

Data Analysis:

The timing of occurrence of low interstitial glucose levels and rapid glucose level decline will be analyzed with the timing of clinical concerns raised about the flap. The systemic glucose level will be used as a control for the flap glucose level. The investigators aim to analyze the temporal correlation between interstitial glucose measurements and clinical findings of the flap's vascular status (eg. vessel occlusion, ischemia). Statistical analysis will be done with assistance by a biostatistician.

Detection of Flap Ischemia Using Interstitial Glucose Monitor

Postoperative Monitoring of Tissue Perfusion in Microvascular Free Flaps Using Continuous Interstitial Glucose Monitoring Device: A Pilot Study

Thoma, Achilleas

Jiayi Hu

Matthew McRae

Hamilton Health Sciences Corporation

Associate Professor

Participants in whom superficial temporal vessels were used as the recipient vessels.

Participants in whom cervical vessels were used as the recipient vessels.

Free tissue flaps harvesting and microanastomosis were performed by the same surgeon and in a similar way in both group. Postoperative course, and complications were recorded and analyzed.

Recipient vessel selected for microanastomosis

Bruno A Sousa, MD

The goal of this clinical trial is to compare the postoperative outcomes based on superficial temporal versus cervical recipient vessels for midface and scalp advanced oncologic defects using free tissue flap for reconstruction.

The main question it aims to answer is:

• Which recipient vessel is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect.

Participants will be undergo resection of advanced malignant tumors of the midface and scalp with subsequent oncological reconstruction using free tissue flap.

Researchers will compare two groups where those in whom superficial temporal vessels will be used as the recipient vessels (group A) and those in whom cervical vessels will be used as the recipient vessels (group B) to see if there is a recipient vessel who is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect.

Advanced oncologic defects of the midface and scalp are a significant challenge to the reconstructive head neck surgeon, who must consider the need for midfacial projection, rehabilitation, and function restoration. Free flaps reconstruction in the midface and scalp region are the gold standard for advanced cases. There is no consensus in the literature on which recipient vessel is most suitable for performing microanastomosis using free flaps for advanced midface and scalp oncologic defect. The aim of this clinical trial is prospectively compare the results of microvascular flap reconstruction of midface and scalp advanced oncologic defects using superficial temporal versus cervical as recipient vessels. This is a parallel trial with permuted block randomization of patients who will be undergone a midface and scalp oncologic reconstruction with free tissue flap. Two groups will be analyzed: those in whom superficial temporal vessels will be used as the recipient vessels (group A) and those in whom cervical vessels will be used as the recipient vessels (group B). Allocation ratio will de 1:1 participants. Patient gender and age, cause and localization of the defect, flap choice for reconstruction, recipient vessels, intraoperative outcome, postoperative course, and complications were recorded and analyzed. Considering that this is a disease with rare staging, the calculated sample size was 26, but it will be increased by 30% (total of 34 participants who will be selected) since the death rate of these patients ranges from 8-25% A Fisher's exact test will be used to compare outcomes between the 2 groups.

Parallel group trial design with allocation ratio of 1:1 and permuted block randomization

The care provider knows the surgical intervention and the randomized participant doesn´t know the recipient vessel performed

Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp

Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp: Prospective Randomized Study

Adequate perfusion of the free tissue flap was assessed using Doppler flowmetry, flap bleeding time after puncture, color, texture and turgor. Both venous and arterial thrombosis were evaluated by these methods in order to detect whether there was any evidence of low or absence of vascular perfusion of the flap.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Leg Function and ADL After ALT Reconstruction for Head and Neck Cancer	NCT02332161	Free Tissue Fla... Head and Neck N...	surveys, evalua...	18 Years -	University of Chicago
Detection of Flap Ischemia Using Interstitial Glucose Monitor	NCT02604069	Free Tissue Fla...	Continuous Gluc...	-	Hamilton Health Sciences Corporation
Detection of Flap Ischemia Using Interstitial Glucose Monitor	NCT02604069	Free Tissue Fla...	Continuous Gluc...	-	Hamilton Health Sciences Corporation
Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp	NCT05749120	Head Neck Neopl...	Recipient vesse...	14 Years -	Instituto Nacional de Cancer, Brazil
Detection of Flap Ischemia Using Interstitial Glucose Monitor	NCT02604069	Free Tissue Fla...	Continuous Gluc...	-	Hamilton Health Sciences Corporation

Spots Global Cancer Trial Database for free tissue flaps