Neoplasms

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Carcinoma

Hyperthermia

Carcinoma, Transitional Cell

Intraoperative Complications

Fever

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy.

Participants in the control group will receive radical cystectomy alone.

Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy

hyperthermic intravesical perfusion

Huaqi Yin

Huaqi Yin, MD.

To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety.

The participants will be divided into two groups (the experimental group and control group). Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Participants in the control group will receive radical cystectomy alone.

After follow-up, the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety will be evaluated.

The participants will be divided into two groups (the experimental group and control group). Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Participants in the control group will receive radical cystectomy alone.

The participants will be randomly (1:1) divided into the experimental and control groups.

Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma

The Effect of Hyperthermic Intravesical Perfusion on the Risk of Intraoperative Implantation of Muscle-invasive Bladder Urothelial Carcinoma and Its Safety Analysis

The rate of intraoperative tumor cell dissemination will be evaluated by lavage cytology of operating field

Disease progression was defined as recurrence or metastasis

Henan Cancer Hospital

Digestive System Diseases

Recurrence

Postoperative Complications

Disease Progression

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients undergo robot-assisted resections.

Patients undergo laparoscopic resections.

Arm I: Robot-assisted resection using da vinci system.

Robot-assisted resection

Arm II: Traditional laparoscopic resection.

Laparoscopic resection

Jianmin Xu, Ph.D., M.D.

The purpose of this study is to evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.

Laparoscopic surgery as the treatment for colon cancer has been widely recognized. But its use for rectal cancer is still controversial. Previous trials have shown that although the long-term survival outcomes were similar, laparoscopic surgery did not reach the non-inferiority in terms of local tumor radical resection, compared with open surgery. Robotic techniques are considered to improve the quality of surgery with three-dimensional vision, stable camera platform and flexible robotic arms. Meta-analyses have shown that compared with laparoscopic surgery, robotic surgery could improve surgical quality in terms of open conversion, circumferential resection margin, postoperative complications, postoperative recovery, and quality of life, with similar long-term survival. However, these evidences mainly came from retrospective studies and small-scale randomized controlled trials with low quality. There still needs high-quality clinical trials to confirm the advantages of robotic surgery for rectal cancer.

Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer

Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial

The proportion of patients with any cancer recurrence in the pelvic or perineal area

The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor

The proportion of patients with any complications occurred within 30 days after surgery

Time from surgery to any recurrence, metastases or death

Time from making skin incision to suturing the incision during the surgery

The proportion of patients with the use of a laparotomy incision for any part of the TME procedure or lymph nodes dissection during the surgery

Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.

The proximal/distal resection margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.

The number of lymph node found from the surgical specimen

The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.

This section is assessed using a self-rating scale "International prostate symptom score" (IPSS).

This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).

This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).

Fudan University

Head of Colorectal Surgery

Heart and Blood Diseases

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Thrombosis

Hemorrhage

Head and Neck Neoplasms

Hemostatic Disorders

Blood Coagulation Disorders

Vitamin K Deficiency

Hypokalemia

Potassium Deficiency

Embolism

Embolism and Thrombosis

Vascular Diseases

Hematologic Diseases

Hemorrhagic Disorders

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Micronutrients

All Drugs and Chemicals

Coagulants

Vitamins

Vitamin K

Menadione

Menaquinone

Naphthoquinone

Phylloquinone

Patients undergoing head and neck microvascular free flap surgery at Skåne University Hospital, Lund, Sweden.

Caroline U Nilsson, MD, PhD

For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap.

Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery.

The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.

Microvascular reconstructive free flap surgery is an important part of the recommended treatment for extensive head and neck tumors. However, the procedure includes risks of perioperative coagulation related complications, such as bleeding, but also thrombosis in the flap blood vessels. In about 10% of cases this requires reoperation, but, in spite of intense efforts, about 5% of all patients suffer from flap failure, i.e. necrosis of the free flap. This results in significant suffering for the patients who must undergo further surgery and oftentimes considerable prolonged hospital stay etc. This in turn leads to increased health care costs. There are several indications that tendency towards thrombosis can increase the risk of flap failure.

Previous studies have indicated that increased levels of fibrinogen and inherited thrombophilia, such as APC resistance, are associated with thrombotic free flap complications, but more conventional coagulation parameters, such as PK/INR and aPTT have not shown the same connection. Low fibrinogen levels have also been associated with bleeding complications.

Most patients undergoing the above mentioned surgery receive anticoagulant therapy. However, there is no international consensus on any specific pharmacological regime. Many different prophylactic therapies are used, including low molecular weight heparin, dextran and acetylsalicylic acid. Still coagulation-related complications are difficult to prevent.

Defective coagulation apparently seems to be associated with bleeding and thrombotic perioperative complications. It would therefore be desirable to increase the knowledge about factors influencing the development of these complications, and the patients at risk for them. ROTEM, rotational thromboelastometry, is a viscoelastic essay that provides a more global view of the hemostatic potential in whole blood, and it is also one of few more advanced assays that can be analyzed around the clock in many Swedish hospitals.

The aim of this project is to study perioperative coagulation and vitamin K status, and thereby further on hopefully be able to prevent, and improve the treatment of, bleeding and thrombosis related complications in patients undergoing head and neck microvascular free flap surgery.

Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery

Perioperative changes in ROTEM MCF (EXTEM). Baseline values measured at start of surgery (day 0), thereafter repeated measurements are made until day 6. Power calculation is based on an expected change in ROTEM MCF (EXTEM) from day 0 to postoperative day 2 (based on Lison et al, Blood Coagul Fibrinolysis. 2011.).

Perioperative changes in ROTEM Clotting Time (CT, s). Baseline values measured at start of surgery (day 0), thereafter repeated measurements are made until day 6.

Perioperative changes in ROTEM Clot Formation Time (CFT, s).

Perioperative changes in ROTEM alpha angle (°).

Perioperative changes in ROTEM Lysis Index 60 (LI60, %).

Perioperative changes in ROTEM Maximum Clot Firmness (mm).

Perioperative changes in prothrombin time (INR).

Perioperative changes in activated partial thromboplastin time (APTT, s).

Perioperative changes in thrombocyte levels (number/L).

Perioperative changes in thrombin generation; lag time (s).

Perioperative changes in thrombin generation; peak thrombin (nM).

Perioperative changes in thrombin generation; area under the curve (AUC).

Perioperative changes in protein C (kIU/L).

Perioperative changes in protein S (kIU/L).

Perioperative changes in fibrinogen (g/L).

Perioperative changes in antithrombin (kIU/L).

Perioperative changes in plasmin-antiplasmin complex, PAP (μg/L).

Perioperative changes in the vitamin K-dependent protein Gas6 (ng/mL).

Perioperative changes in the vitamin K-dependent protein dp-uc-MGP (pM/L).

Perioperative changes in the vitamin K-dependent protein Axl-receptor (pg/mL).

Perioperative changes in the vitamin K-dependent protein PIVKA-II (mAU/mL).

Connection between perioperative complications (thrombotic \[arterial/venous\] or bleeding) in the surgical site and abnormal levels of coagulation parameters mentioned above.

Perioperative changes in ROTEM INTEM Maximum Clot Firmness (MCF, mm).

Perioperative changes in ROTEM INTEM Clotting Time (CT, s).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma	NCT05276167	High-Risk, Non-... Perfusion; Comp... Intraoperative ...	hyperthermic in...	18 Years - 75 Years	Henan Cancer Hospital
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer	NCT02817126	Rectal Carcinom...	Robot-assisted ... Laparoscopic re...	18 Years - 80 Years	Fudan University
Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery	NCT04517461	Head and Neck C... Intraoperative ... Coagulation Dis... Vitamin K Defic... Thrombosis Anticoagulants ... Head and Neck P...		18 Years -	Region Skane

Spots Global Cancer Trial Database for intraoperative complications