Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy

NCT03528057 | Withdrawn FDA Device

• 1 other identifier: STU00206993
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate whether Hemostatic Agents (HA) make a significant clinical difference in patient outcomes when used for Robotic-Assisted Laparoscopic Partial Nephrectomy (RALPN). The result of this trial will determine whether HAs are necessary for use during RALPN or if they can be omitted from the surgical tools available during this procedure. This study has a direct clinical implication on a patient's outcomes following RALPN, specifically whether patients will have better, worse, or unchanged outcomes with RALPN if HAs are used.

Conditions

Robotic-Assisted Laparoscopic Partial Nephrectomy; Hemostatic Agents; Renal Malignant Tumor

Keywords

Kidney

Outcome Measures

Primary Outcomes (1)

• Absolute change in hemoglobin

  This will be measured as the difference between the hemoglobin obtained postoperatively (measured at approximately 4 am in the morning after surgery) and the hemoglobin obtained preoperatively in the holding area on the day of surgery.

  Morning after surgery

Secondary Outcomes (7)

• Total number of major bleeding complications

  30 days following surgery

• Safety monitoring parameters

  30 days following surgery

• Operating room parameters

  Total duration of surgery

• Operating room parameters

  Total duration of surgery

• Operating room parameters

  Total duration of surgery

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Patients undergoing RALPN with the use of HAs by a surgeon.

Device: Hemostat

Group 2

NO INTERVENTION

Patients undergoing RALPN without the use of HAs by a surgeon

Interventions

Hemostat DEVICE

Hemostatic agents, if used at all during surgery, will be applied laparoscopically into the tumor bed to stop bleeding. The type of hemostat will be decided by the surgeon according to the anatomy of the tumor bed.

Also known as: Surgicel Nu-Knit, FLOSEAL Hemostatic Matrix

Group 1

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 years and older.
• Patients must have a solid or cystic renal mass suspicious for malignancy by imaging with ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
• Patients must be initially scheduled RALPN as opposed to radical nephrectomy or other techniques for partial nephrectomy such as open surgery or pure laparoscopy without robot assistance.
• Patients with bilateral kidneys or a solitary kidney, so long as these are native kidneys as opposed to a transplanted kidney.
• Patients can have the common single renal artery and single renal vein, or they can have common variants such as two renal arteries and/or two renal veins.

You may not qualify if:

• Patients on hemodialysis.
• Patients who have had a renal transplantation.
• Patients on therapeutic anticoagulation prior to surgery (example anticoagulants include: aspirin 325 mg daily, clopidogrel, warfarin, fondaparinux, dabigatran, and rivaroxaban). However, patients who take aspirin 81 mg daily as their daily regimen will be included.
• Patients with bleeding disorders (example: hemophilia) and other documented coagulopathy (example: chronic liver disease) with international normalized ratio (INR) \> 1.0 at baseline.
• Patients who have had a prior surgical procedure, aside from percutaneous renal biopsy, on the kidney in the current operation.
• Patients with over 100 mL of estimated blood loss (calculated by anesthesia team using the suction canisters) prior to clamping of the renal hilum will be excluded.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Robert Nadler, MD

  Professor of Urology, Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The surgical team and the patient will be blinded as to which arm the patient will be assigned both at the time of recruitment in the clinic and at the start of surgery. The patient and surgeon will both be blinded at the start of the surgery (RALPN). The surgeon will be informed intra-operatively during the renorrhaphy portion of the procedure as to which arm the patient will be assigned, at which point he will be un-blinded. Following completion of the entire surgery, the patient will also be informed as to which arm he/she was randomized upon request.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Department of Urology

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 17, 2018
• Study Start: April 18, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

US (1)