Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Coagulants

All Drugs and Chemicals

Hemostatics

In the Floseal group, the sites of bleeding were covered with Floseal under direct vision with a laparoscopic applicator and ovarian cortex was closed on itself and waited for 2 minutes for Floseal to act. Then, subsequently bleeding sites were reexamined with irrigation.

In the bipolar group, hemostasis of the ovarian parenchyma was achieved with selective minimal (20-30 watt current) bipolar coagulation without excessive coagulation of surgical defect to avoid damaging the ovary.

Floseal

Bipolar coagulation

Taejong Song, M.D

Laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of the ovarian wound ground using bipolar coagulation. However, the hemostasis with bipolar coagulation could result in the damage of ovarian reserve and decrease the response of the ovaries to hormonal stimulation for assisted reproductive technologies. The possible mechanism may contribute to thermal destruction of ovarian follicles by excessive use of bipolar coagulation for hemostasis purposes.

To avoid additional ovarian tissue damage by conventional bipolar coagulation being potentially important ovarian reproductive function, hemostasis using various topical hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. Among them, FloSeal (Baxter Healthcare Corporation, Deerfield, IL, USA) is a hemostatic matrix sealant composed of a gelatin-based matrix and thrombin solution. On coming into contact with blood after application at a bleeding site, the gelatin particles swell and tamponade bleeding. The bulk of the gelatin matrix-thrombin composite has the effect of slowing blood flow and providing exposure to a high thrombin concentration, thus hastening clot formation. Therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where there is superficially pervasive focus of bleeding.

Ovarian reserve is defined as the functional potential of the ovary, which reflects the number and quality of antral follicles left in the ovary, and is correlated with the response to ovarian stimulation using exogenous gonadotropin. Serum anti-Müllerian hormone (AMH) has been accepted as the most reliable and easily measurable marker for postoperative assessment of ovarian reserve.

The investigators conducted a multicenter, large-scale, randomized controlled trial to investigate whether hemostasis by Floseal was superior to that by bipolar coagulation in preserving ovarian reserve by assessing serial AMH levels in patients undergoing laparoscopic ovarian cystectomy for benign ovarian cysts.

Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix

Additional Benefit of Hemostatic Sealant in Preserving Ovarian Reserve During Laparoscopic Ovarian Cystectomy: a Randomized Controlled Trial

The primary outcome of the study was the impact on ovarian reserve determined by serum AMH levels after the applications of two hemostatic techniques for ovarian wound bleeding.

CHA University

Professor

Blood and Lymph Conditions

Lymphocele

Lymphatic Diseases

application of floseal to one side of pelvis after pelvic lymphadenectomy

counter-site of pelvis; no intervention after pelvic lymphadenectomy

application of floseal on intervention arm

Yun Hwan Kim, Dr

Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.

Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.

A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.

The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.

The investigators designed prospective randomized controlled study as a pilot study.

The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.

Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer

Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study

Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.

lymphedema symptoms and sign at post-operative 3 and 6 month

Baxter Healthcare Corporation

Ewha Womans University Mokdong Hospital

Assistant Professor

Wounds and Injuries

Digestive System Diseases

Hemorrhage

Hyperthermia

Fever

Carcinoma

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Pharmaceutical Solutions

Thrombin

Routine use of Floseal during cytoreductive and HIPEC surgery

FloSeal not used during CRS and HIPEC procedure

FloSeal

Pierre Dubé

Introduction

Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. It is considered a high risk procedure and post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to control the bleeding will be necessary. Major causes of bleeding are : radical resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.

To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of these is the liberal use of FloSeal, but there is no data in this particular field of interest. Over the last 18 months, the investigators have started to use FloSeal in all their cases with large PC and they have observed a dramatic reduction in the rate of reoperation for bleeding and probably secondarily, in the use of blood products, but this has not been measured.

Hypothesis

FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.

Primary objective

To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC procedure in the treatment of PC.

Secondary objectives

* To evaluate if the use of FloSeal can reduce operative blood loss.
* To evaluate if the use of FloSeal can reduce the need of blood products after CRS and HIPEC procedure.
* To evaluate if the use of FloSeal can have an impact on other common surgical complications (which can be indirectly bleeding related).
* To evaluate if the use of FloSeal can have an impact on length of hospital stay.

FloSeal in CRS and HIPEC

Can FloSeal Reduce the Risk of Intra-abdominal Bleeding After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Performed for the Treatment of Peritoneal Carcinomatosis ?

packed red blood cells, fresh frozen plasma, platelets, specific coagulation factors and cryoprecipitates

According to the Dindo-Clavien postoperative complications classification

Hospital discharge is defined in our study as medical discharge

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix	NCT01857466	Ovarian Cysts	Floseal Bipolar coagula...	18 Years - 45 Years	CHA University
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer	NCT01974193	Gynecologic Can...	Floseal	20 Years - 80 Years	Ewha Womans University Mokdong Hospital
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer	NCT01974193	Gynecologic Can...	Floseal	20 Years - 80 Years	Ewha Womans University Mokdong Hospital
FloSeal in CRS and HIPEC	NCT01957852	Peritoneal Carc...	FloSeal	18 Years -	Maisonneuve-Rosemont Hospital

Spots Global Cancer Trial Database for floseal

Every month we try and update this database with for floseal 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 floseal

Every month we try and update this database with for floseal 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 floseal 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.