Heart and Blood Diseases

All Conditions

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Hypotension

Head and Neck Neoplasms

Mouth Neoplasms

Vascular Diseases

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Cardiotonic Agents

Vasodilator Agents

Epinephrine

Norepinephrine

Dobutamine

Racepinephrine

Epinephryl borate

Sympathomimetics

Dopexamine

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Protective Agents

Dopamine

Dopamine Agonists

Dopamine Agents

Epinephrine, Norepinephrine, Dobutamine, Dopexamine

0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg

Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg

Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg

Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg

Stephen R Watt-Smith, FDSRCS, MD

Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.

The optimal sympathomimetic drug to support blood pressure without adverse vasoconstriction of free flap circulation remains unknown. This study examined the effects of four agents (epinephrine, norepinephrine, dobutamine and dopexamine) on free flaps following resection of head and neck cancer.

Twenty five patients were recruited to the study. Each patient received an infusion of the four drugs in a random order with an intervening washout period between drugs, at four infusion rates. Continuous free flap skin blood flow monitoring was performed using laser Doppler velocimetry, with a second sensor on normal skin acting as a control. Global cardiovascular variables were monitored using the LiDCO Rapid pulse contour analysis system.

Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery

An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study

Oxford University Hospitals NHS Trust

Mr SR Watt-Smith

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Hemorrhage

Blood Loss, Surgical

Intraoperative Complications

Coagulants

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA

Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline

Experimental group will receive TXA intraoperatively (15mg/kg IV, once at beginning of case then re dose at 4hrs if operation goes longer) at the time of their surgery.

Tranexamic acid

Control group will receive same volume equivalent of saline intravenously at the time of their surgery.

Placebo

Rachel Park, MD

Rachel H Park, MD

John Stranix, MD

Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with ERAS protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as DVT/PE.

Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial

Post-op day 1 Hemoglobin - Pre-op Hemogobin

Thromboembolic event, hematoma, seroma, flap compromise/ failure

University of Virginia

Assistant Professor of Plastics Surgery

robotic-assisted or endoscopic assisted mastectomies

A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022. Patients will be grouped based on how the mastectomy was performed, via minimally invasive or conventional approach. Demographic data, flap profile, vessel anastomosis and post-operative complication will be retrospectively reviewed. Data collection includes patient demographics, previous breast surgical history, breast cancer history and adjuvant therapy, surgical details and postoperative events.

Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy

Six Steps for a Successful Aesthetic Free Flap Reconstruction Shaping After Minimally Invasive Mastectomy

If the free flap transferred is successfully survived

Chang Gung Memorial Hospital

Associate Professor

Retrospective group of patients who have not received venous augmentation during their operation.

Retrospective group of patients who have received venous augmentation during their operation.

Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol

Prospective group operated according to the Sahlgrenska recovery protocol.

Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein

Venous augmentation

Pre-, peri-, and post-operative care as described in the ERAS protocol

Traditional ERAS (enhanced recovery after surgery) protocol

Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol

Sahlgrenska recovery protocol

Traditional deep inferior epigastric artery perforator flap (DIEP)

No venous augmentation

Emma Hansson, MD, PhD

Emma Hansson, PhD

Women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. However, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than some other methods, such as implant-based techniques. The main objectives of the present study are to investigate if pre- peri- and postoperative protocols can be safely modified, so the operation demands less resources, while maintaining a low complication rate and a high patient satisfaction.

Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)

Any re-operations performed for any cause during the first 7 days after the operation

Number of days the patient stays in the hospital after the operation

Measured with BREAST-Q reconstruction. The patient scores different items om a scale and a sum score of 0-100 is calculated for each domain. A higher score indicates a higher satisfaction/quality of life.

Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.

Health economical analysis of direct and indirect cost related to the different protocols

Vastra Gotaland Region

This group will continue to receive the routine standard of care during their treatment journey.

In addition to the standard of care, this group will complete an audiovisual digital education module during their postoperative stay in hospital.

Multimedia education provided to the intervention group via a digital tablet

Digital Education Group

Eitan Prisman, MD, FRCSC

Head and neck cancer is a disease that has a particular propensity for treatment-related morbidity. It is hypothesized that patients who are more involved in their care in hospital and who are actively provided with more treatment-related education may report increased satisfaction and have improved overall outcomes. The investigators aim to determine whether delivery of patient-centred education in a multimedia format via a digital platform has an impact on overall satisfaction and perceived quality of medical care.

Digital Patient Education Platform in Head and Neck Cancer

Post-Operative Patient-Centred Care Education Administration in Head and Neck Cancer Patients - A Digital Platform

Measured via a 5-point Likert scale from a survey collected on discharge day

University of British Columbia

Breast Diseases

Skin Diseases

Superficial Inferior Epigastric Artery Clamped; Vein Unclamped

Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are clamped

Both Superficial Inferior Artery and Vein Clamped

Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are unclamped

Superficial Inferior Epigastric Vessels both unclamped

Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is unclamped and the Vein is clamped

SIE Artery Unclamped, Vein Clamped

Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is clamped and the Vein is unclamped

SIE Artery clamped, Vein unclamped

Adam Gilmour, MBChB, MRCS (Ed)

The purpose of this study is to determine in-vivo the effects the contralateral superficial inferior epigastric vascular system has on the perfusion of Zone IV of deep inferior epigastric perforator flaps.

* Breast cancer is the commonest cancer to affect women in the UK. Current guidelines state that; disease permitting, all females due to undergo mastectomy for breast cancer should be offered reconstruction. Autologous free tissue transfer using abdominal tissue remains an excellent option for breast reconstruction due the readily available fatty tissue and the low donor site morbidity. In recent years the trend has been to base the abdominal tissue on perforating vessels rather than to routinely harvest muscle along with the flap; thus further potentially reducing donor site morbidity. Abdominal tissue based upon the Deep Inferior Epigastric Perforator (DIEP) system is a well recognised option in breast reconstruction.
* This procedure involves harvesting the lower abdominal tissue basing its blood supply on one of the Deep Inferior Epigastric Perforating Arteries and concomitant veins. These are branches of the External iliac artery which perforate through the rectus muscle or the intertendinous intersections.
* A large volume of tissue can be harvested based on a single perforator.
* Hartrampf divided the abdominal tissues into distinct perfusion zones I-IV based upon their location to the perforating artery. Zone I overlies the perforating vessel, Zone II is across the midline adjacent to perforating vessel. Zone III is on the ipsilateral periphery to the perforating vessel and Zone IV is on the furthest periphery on the contralateral side from the perforator. Over the years this has undergone debate and many have advocated that zones II-III (according to Hartrampfs original classification) should be switched. However everyone remains clear on the term Zone IV. Zone IV is classically the area of the flap which receives least perfusion/drainage from the perforating vessels and as such is most liable to undergo congestion and tissue ischaemia leading to fat/skin necrosis. As such many surgeons routinely excise zone IV from the DIEP flap prior to transfer to the chest defect. This obviously leads to a reduction in the volume of tissue available for reconstruction.
* Classically most problems with zone IV / flap perfusion tend to be related to venous congestion.
* Many surgeons advocate the use of the superficial inferior epigastric vein as a "lifeboat" vessel in salvaging a congested DIEP and have published their results in doing so.
* There are however no in-vivo studies showing the full contribution of the superficial vascular system in flaps based primarily upon the Deep Inferior Epigastric Perforating Vessels. A recent study using preoperative CTs has shown that there are "macrovascular-shunts" between the deep arterial system and the superficial venous system but the implications of this have yet to be established.
* Fluoroscopy using indocyanine green is an established method at looking at tissue perfusion in free flaps.
* Laser Doppler imaging is another well described technique for the monitoring / assessment of tissue perfusion in plastic surgery operations.
* By further understanding the perfusion of the DIEP flaps the investigators hope to improve flap survivability and also the volume of flap which can be used.
* Patients due to undergo breast reconstruction with a free DIEP flap by the senior researcher/surgeon will be identified.
* On the day of their operation the DIEP flap will be raised as normal on one of the DIEP arteries from either side. The superficial vascular system will be dissected free on the contralateral side.
* The flap will then be scanned with Laser Doppler Imaging and then the SPY scanner (indocyanine green angiography coupled with fluoroscopy)
* This will take place in a randomized fashion as follows
* Superficial Inferior Epigastric Artery Clamped; Vein Unclamped
* Superficial Inferior Epigastric Artery Unclamped; Vein Clamped
* Both Artery and Vein Clamped
* Both Artery And Vein Unclamped
* There will be a 5minute pause between each intervention to allow perfusion to stabilize. Previous research (awaiting publication) within our department has shown that this is the necessary amount of time to allow stabilization.
* The scanning period will be carried out during the natural rest break of the operating surgeon and as such will not add significantly to the length of the procedure.
* Once the scanning process is finished the operation will then proceed as standard with DIEP flap being disconnected from the abdomen and reconnected in the chest to reconstruct the breast.

Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps

The Potential Role of the Superficial Inferior Epigastric Vascular System in the Perfusion of Zone IV of Deep Inferior Epigastric Perforator (DIEP) Flaps

Tissue Perfusion to Zone IV will be assessed intra-operatively using Laser Doppler Imaging and angiography whilst various components of the Contralateral Superficial Inferior Epigastic Artery / Vein are clamped/unclamped.

Canniesburn Research Trust

NHS Greater Glasgow and Clyde

Principal Investigator - Clinical Laser Research Fellow

Behaviors and Mental Disorders

Quality of Life

Complement System Proteins

Patients with resensitized free flap by neurorrhaphy

Patients without resensitized free flap by neurorrhaphy.

During the surgery, the flap is removed from its donor site, placed on the recipient site (instead of carcinological excision) and its survival is ensured by arterial and venous anastomosis (to the artery and facial vein or to the external carotid artery and thyro-linguofacial veinous trunk).

We then propose a reconstruction complement: nerve anastomosis (neurorrhaphy) to the lingual nerve for the antebrachioradial and anterolateral thigh flaps, and to the lower alveolar nerve for the fibular bone flaps. This supplement is performed during microsurgical time by a suture for the patient in group 1.

neurorrhaphy

Patrick LACARIN

Arnaud DEPEYRE

Isabelle BARTHELEMY

Nicolas SAROUL

Nathalie PHAM DANG

Amaury CHEVALEYRE

Charles IRTHUM

Marielle LONGEAC

The surgical procedure consists in removing a tumor of the oral cavity and then repairing the oral defect by the use of a free flap. A free flap is tissue composed of skin and aponeurosis taken from the thigh or forearm, or tissue composed of bone taken from the leg to fill in tissue loss. This tissue is vascularized by a vein and an artery that are removed with the flap to ensure its survival. Investigator would also like to harvest the nerve involved in the sensitivity of the skin flap to suture it to a nerve which will be located near the reconstructed area, and this to enhance sensitivity of the reconstructed oral cavity. Thanks to this, investigator also wish to highlight that this resensitization would improve the patient's quality of life particularly regarding his major oral functions (swallowing, phonation, sensation of cold and hot felt, chewing).

Investigator therefore seek to demonstrate that suturing the nerve will give to the patient the ability back to feel tactile and thermal sensations This is the purpose of the study.

Investigator will compare patients in whom the nervous suture will be performed and patients in whom it will not. If a significant difference in oral sensitivity is noted between these 2 groups, investigator can support our thesis: suturing the flap nerve increases its ability to regain sensitivity.

All patients are first diagnosed in consultation and presented at a carcinologic multidisciplinary consultation during which an individually adapted treatment is proposed (according to the French "Plan Cancer"). If it consists in a surgery with reconstruction using free flap technique at the same time, Investigator then propose to the patient to integrate our study. The possibility to participate to this study is therefore proposed to the patient on the same day that the plan of treatment is presented. The patient has a period of reflection, minimal time necessary to mature his reflection and make their choice with their loved ones and decide if they agree to participate to the study. His answer is required the day before the surgery. This represents a reflection period of two weeks on average. If he accepts it, computer software (RedCap®) will determine at random if the surgical team will perform a nervous suture or not. As a result, two groups patients are then created: one with nervous suture and one with no nervous suture. By comparing these two groups, investigator hope to demonstrate that there will be more patients with a flap sensitive in the "with nerve suture" group than in the "without nerve suture" group.

Investigator will then collect data from tests and questionnaires allowing us to judge the resensitization of the flap during follow-up consultations at 3, 6 months then at 1 year postoperatively in parallel follow-up consultations. That is to say that the patient therefore comes for a consultation as part of his cancer follow up and investigator take advantage of this time to carry out tests and questionnaires. This adds about 20 minutes of consultation time.

A preoperative evaluation will be done before the surgery corresponding to the basal state calibration. During these consultations, investigator perform two tests and investigator will provide 2 quality of life questionnaires to fill out:

* The two-discriminating points test: two points are applied on the flap at different distances and the patient must indicate if he feels one or two points.
* The hot/cold test: hot water and cold water are applied on the flap separately, and the patient should indicate if he feels the temperature differences.
* The QLQ-C30 and EOTRC H\&N 35 questionnaires: several questions concerning the quality of life are asked to the patient who must answer them as honestly as possible.

After collecting all this information, investigator can compare the sensitivity of free flaps with or without nerve suture.

In parallel, investigator will also evaluate the economic impact and cost that this can represent by comparing the operating and hospitalization times of patients in each group. Investigator believe that the operating time is not increased nor the length of hospitalization and therefore that there is no additional cost.

Comparison of primary and secondary outcomes measures between group 1 (resensitization by neurorrhaphy) and group 2 patients (No resensitization by neurorrhaphy).

Patients randomly included in the groups according to a randomization software (RedCap)

Evaluation of the Interest of the Neurorrhaphy in Resensitizing Free Flaps

Evaluation of the Interest of the Neurorrhaphy in the Resensitisation of Free Flaps in Maxillofacial Reconstructive Surgery. Randomized Prospective Study.

It is a method of discriminating evaluation of epicritic sensitivity validated by the scientific literature

Thermoalgic resensitization measured by Hot test

Thermoalgic resensitization measured by cold test

The QLQ-C30 is a are self-administered questionnaire and validated by the European Organisation for Research and Treatment of Cancer assessing overall health status of patients. The QLQ-C30 focuses on patients' overall quality of life and disease experience

The EORTC H\&N 35 questionnaires are self-administered and validated by the European Organisation for Research and Treatment of Cancer assessing overall health status of patients. The EORTC H\&N 35 focuses on mouth sensations and major oral functions such as chewing, phonation or swallowing

The VHI is a self-assessment scale (established by Jacobson et al., 1997) adapted in French that provides a psychometric inventory of vocal disability that can be used for a wide variety of conditions (Woisard et al., 2004). The higher the score is, the greater the feeling of disability. The VHI is rated on 120 points. For each question, the scale used is a Likert analog scale, a frequency variable rated from 0 to 4 (0=never; 1=almost never; 2=sometimes; 3=almost always; 4=always). Its three subscales are each composed of 30 assertions

The DHI is a French self-administered questionnaire on the quality of life specific to swallowing. It was written and validated in 2006 by Woisard and Puech, based on the Voice Handicap Index (VHI) model (Crestani, Moerman et al.), (Woisard \& Lepage, 2010). It consists of three domains, each containing ten items:

The investigators collect the operating time and hospitalisation time for each patient to demonstrate that our operating technique does not generate any additional costs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery	NCT01418118	Oral Cancer Head and Neck C... Free Flap Hypotension	Epinephrine Norepinephrine Dobutamine Dopexamine	17 Years -	Oxford University Hospitals NHS Trust
Role of TXA in Patients Undergoing Breast Free Flap Reconstruction	NCT06428682	Breast Cancer Blood Loss, Sur...	Tranexamic acid Placebo	18 Years -	University of Virginia
Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy	NCT05943873	Breast Reconstr... Breast Cancer		-	Chang Gung Memorial Hospital
Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)	NCT05363189	Breast Reconstr... Breast Cancer	Venous augmenta... Traditional ERA... Sahlgrenska rec... No venous augme...	18 Years - 100 Years	Vastra Gotaland Region
Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)	NCT05363189	Breast Reconstr... Breast Cancer	Venous augmenta... Traditional ERA... Sahlgrenska rec... No venous augme...	18 Years - 100 Years	Vastra Gotaland Region
Digital Patient Education Platform in Head and Neck Cancer	NCT05211778	Head and Neck C...	Digital Educati...	19 Years -	University of British Columbia
Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps	NCT01464970	Breast Cancer	Both Superficia... Superficial Inf... SIE Artery Uncl... SIE Artery clam...	18 Years - 70 Years	NHS Greater Glasgow and Clyde
Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps	NCT01464970	Breast Cancer	Both Superficia... Superficial Inf... SIE Artery Uncl... SIE Artery clam...	18 Years - 70 Years	NHS Greater Glasgow and Clyde
Evaluation of the Interest of the Neurorrhaphy in Resensitizing Free Flaps	NCT03677349	Reconstructive ...	neurorrhaphy	18 Years -	University Hospital, Clermont-Ferrand

Spots Global Cancer Trial Database for free flap

Every month we try and update this database with for free flap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for free flap

Every month we try and update this database with for free flap cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for free flap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.