Nervous System Diseases

Heart and Blood Diseases

All Conditions

Neoplasms

Stroke

Head and Neck Neoplasms

Cardiotonic Agents

All Drugs and Chemicals

Central Nervous System Depressants

Other Dietary Supplements

Dobutamine

Benzocaine

Tannic Acid

In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.

Standard fluid therapy

In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.

Conservative fluid therapy

Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Investigators will compare the effect of goal-directed fluid therapy using stroke volume variation on recovery in patients undergoing free flap reconstruction after head and neck cancer resection.

Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection

Yonsei University

Symptoms and General Pathology

Thrombosis

Ischemia

Reperfusion Injury

Coagulants

Anesthetics

Hemostatics

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.

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

Remote ischemic preconditioning

Sham

Anne-Mette Hvas, M.D., Ph.D.

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.

Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial

Aarhus University Hospital Skejby

M.D.

Hematoma

Embolism

Embolism and Thrombosis

Vascular Diseases

Hemorrhage

No intervention, this is an observational study

Free Flap surgery

Ying-Chi Lin, Ph.D.

This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022.

Patient information are collected from the electronic medical records retrospectively:

Head and Neck cancer diagnosis: The International Classification of Diseases, Tenth Revision (ICD-10), which included C00-C14, C31, C32, C73, C75.0, C75.4 and C41.1.

The cancer stage, alcohol use, betel nut, and smoking, and baseline comorbidities.

Surgical characteristics including flap history, ablation time, reconstruction time, donor sites, recipient sites, neck dissection, flap size, anastomosis, artery types, vein types, intraoperative sealants used, and intravenous calcium channel blocker nicardipine to control hypertension after surgery.

Adverse Events for Free Flap Surgery in Head and Neck Cancer

Prescription Pattern and Adverse Events of Postoperative Antithrombotic Regimes for Free Flap Surgery in Head and Neck Cancer

Flap necrosis with a need for a new flap or other surgical procedures.

Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung Medical University

Director, Master Degree Program in Toxicology

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Reconstruction with an acellular porcine dermal collagen implant (biological mesh).

Reconstruction with a gluteus maximus myocutaneous flap.

Reconstruction of floor of lesser pelvis with an acellular porcine dermal collagen implant (biological mesh) after extended excision of rectum including levator muscles in advanced low rectal cancer.

Reconstruction with an acellular porcine dermal collagen implant (biological mesh)

Reconstruction of floor of lesser pelvis with an gluteus maximus myocutaneous flap after extended excision of rectum including levator muscles in advanced low rectal cancer.

Reconstruction with a gluteus maximus myocutaneous flap

Markku M Haapamäki, MD, PhD

Jörgen Rutegård, MD, PhD

The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are:

* a technique using a gluteus maximus myocutaneous flap or
* a technique using an acellular porcine collagen implant (biological mesh)

The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap.

The study is interventional, randomized and by definition a comparative effectiveness research project.

Extended abdominoperineal excision (EAPE) of the rectum is the potentially curative operation for rectal carcinomas too low for primary anastomosis, especially if the levator and sphincter musculature is infiltrated. This enlarged operation, when the levator musculature is excised en bloc with the rectum, creates a large defect. Primary closure is often not possible, and reconstruction with prosthetic material or a myocutaneous flap is necessary to avoid a perineal hernia. Implantation of a collagen sheet (biological mesh) has shown preliminary good results and on the other hand, the use of a gluteus myocutaneous flap is routine in many clinics. There is a lack of scientific evidence to prove which method is better for the reconstruction of the lesser pelvic floor.

The current study aims to compare the two reconstruction techniques.

Centres that treat locally advanced rectal cancers with the extended abdominoperineal excision of rectum (EAPE)\[Holm et al 2007\] can participate provided that:

1. the operative technique is standardized according to the study protocol
2. the centre/unit has resources for examinations of participants by a physiotherapist or a nurse
3. the centre/unit has one investigator in charge of the study locally
4. the centre/unit has an operative volume that enables at least 6 patients to be included/randomised during the anticipated three year study phase for inclusions

Centres that do not operate the rectal cancers included in this study can participate by arranging the preoperative examination and physical tests as well as follow-up of patients that are referred to other centres for the operation. In these cases the operating centre cares for the randomisation, operation and start of postoperative rehabilitation while the study follow-up and final rehabilitation can be completed at the patients' primary referral hospital. The primary referral hospital needs a site investigator in charge of study patients just like centres that do the operations.

Patients with primary or recurrent cancers of rectal origin can be included but individual patients can be included only once. Concomitant therapies are allowed and preoperative or postoperative radiation therapy and/or chemotherapy may be given or not according to local multidisciplinary team (MDT) decisions.

Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer

Nordic Extended Abdominoperineal Excision (NEAPE) Study, a RCT Comparing a Porcine Acellular Dermal Collagen Implant (Biological Mesh) With a Gluteus Maximus Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer

Timed-Stands test is a combined measure of physical performance depending on at least muscle strength, balance, tenderness of gluteal skin and muscles and co-ordination of motion.

The Southampton Wound Assessment Scale is a validated measure of wound healing after surgery.

The Dindo-Clavien classification of surgical complications is a validated instrument.

Proportion of patients with the wound healing defect of all patients in the particular study arm

Ability to sit is graded with a scale in three degrees.

A standard visual analogue scale (VAS) from 0-100 mm is used.

EQ-5D and EORTC are validated quality of life instruments

Quality adjusted life year (QALY) is calculated using an quality of life utility index at repeated time points. The utility index is adjusted for the relevant background population.

Local recurrence of rectal cancer detected by clinical or radiological investigation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection	NCT02003066	General Anesthe...	Standard fluid ... Conservative fl...	20 Years - 80 Years	Yonsei University
Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial	NCT02548377	Head and Neck N...	Remote ischemic... Sham	18 Years -	Aarhus University Hospital Skejby
Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection	NCT02003066	General Anesthe...	Standard fluid ... Conservative fl...	20 Years - 80 Years	Yonsei University
Adverse Events for Free Flap Surgery in Head and Neck Cancer	NCT06371365	Surgical Flaps Flap Failure Ri... Hematoma Risk F... Thrombosis Risk...	Free Flap surge...	20 Years -	Kaohsiung Medical University
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer	NCT01347697	Rectal Cancer Defect of Floor...	Reconstruction ... Reconstruction ...	18 Years -	Umeå University

Spots Global Cancer Trial Database for surgical flaps