Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Coagulants

All Drugs and Chemicals

Hemostatics

Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon

Hemostatic Agent

Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon

No Hemostatic Agent

Arieh Shalhav, MD

Scott Eggener, MD

The purpose of this study is to evaluate the necessity of using hemostatic agents as a tool when performing robotic partial nephrectomy in the treatment of kidney cancer. This project asks whether patients who undergo robotic partial nephrectomy without the surgeon using hemostatic agents during the procedure will have the same, fewer, or more complications than when patients undergo this same surgery with the surgeon using hemostatic agents during the procedure.

Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy

The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively and the hemoglobin obtained preoperatively.

Major complications are blood loss requiring transfusion of packed red blood cells, reoperation and endovascular ablation

Safety monitoring parameters including stroke, death, cardiac arrest, myocardial infarction and urine leak

Operating room parameters including number of sutures used during renorrhaphy and capsular closure, duration of renorrhaphy and patients in group 2 with no hemostatic agents who required HA at the surgeons discretion

Total length of all inpatient hospital stay over 30 days measured in days

University of Chicago

Symptoms and General Pathology

Gland and Hormone Related Diseases

Endometriosis

Cysts

Ovarian Cysts

Genital Diseases, Female

Genital Diseases

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Thrombin

Fibrin Tissue Adhesive

During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding.

During operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted.

During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)

Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy

During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

suturing with barbed sutures during laparoscopic ovarian cystectomy

Hyunji Lim, MD

Hee seung Kim, MD/PhD

Ga Won Yim, MD/PhD

Chae Hyeong Lee, MD/PhD

Hee Seung Kim, MD/PhD

This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.

In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.

Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.

Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function

A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma

Reduction rate of AMH level in serum 12 weeks after surgery

Reduction rate of AMH level in serum 48 weeks after surgery

Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control

Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes

The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle

whether patients are transfused during admission period

any adverse events during admission period

time from anesthesia start to delivery of patient to recovery room

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy	NCT04120805	Kidney Cancer	Hemostatic Agen... No Hemostatic A...	18 Years -	University of Chicago
Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function	NCT04643106	Benign Ovarian ...	Hemostatic agen... suturing with b...	19 Years - 45 Years	Seoul National University Hospital

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