Neoplasms

All Conditions

Symptoms and General Pathology

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Adenoma

Neoplasm Metastasis

Syndrome

Cushing Syndrome

Pheochromocytoma

Hyperplasia

Adrenocortical Adenoma

Adrenocortical Carcinoma

Adrenal Gland Neoplasms

Adrenal Gland Diseases

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Adrenal Cortex Neoplasms

Adrenal Cortex Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adrenocortical Hyperfunction

Endocrine System Diseases

Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Genetic Diseases, Inborn

Metabolism, Inborn Errors

Steroid Metabolism, Inborn Errors

Metabolic Diseases

Gonadal Disorders

Adenocarcinoma

Endocrine Gland Neoplasms

Cushing's Syndrome

Adenoma of the Adrenal Gland

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Hyperadrenalism

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

MUDr. Igor Hartmann Ph.D.

Natalia Wiesner

Igor Hartmqnn, MD, PhD

Natalia Wiesner, MD

Igor Hartmann, MD, PhD

The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are:

1. to find the superiority of one the the surgical method mentioned above
2. to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.

Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy

Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study

Initial examination by a urologist and indication for the surgery.

Sampling of biological material: Hemoglobin g/l

Measuring the blood loss in milliliters (ml).

Record the need for conversion to open surgery.

The consumption of special surgical instruments.

Perioperatively, the length of stay in the ICU in days.

Perioperatively, total hospitalization time in days

Perioperatively, blood loss from the drain in mililiters (ml).

Perioperatively, time to remove the abdominal drain in days.

Perioperatively, need for blood substitutes.

Perioperatively, number of forced surgical revisions.

Perioperatively, consumption of analgesics during the hospitalization.

First postoperative visit (14th to 20th postoperative day), sampling of biological material: Hemoglobin g/l

First postoperative visit (14th to 20th postoperative day)- an analysis of perioperative and early postoperative complications according to the Dindo Clavien classification

First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.

Second postoperative visit (85th to 100th postoperative day)- an analysis of late postoperative complications according to the Dindo Clavien classification.

Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions

University Hospital Ostrava

Tomas Bata Hospital, Czech Republic

General University Hospital, Prague

University Hospital Hradec Kralove

University Hospital Olomouc

Head of the urological clinic, MUDr. Igor Hartmann Ph.D.

Behaviors and Mental Disorders

Prostatic Neoplasms

Urinary Incontinence

Enuresis

Urination Disorders

Urologic Diseases

Lower Urinary Tract Symptoms

Urological Manifestations

Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System

Retzius sparing radical prostatectomy da Vinci Surgical System

Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique

Retzius sparing radical prostatectomy

Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique

Vattikuti Urology Institute radical prostatectomy

The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.

da Vinci Surgical System

Mani Menon, MD

To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.

Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.

Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery

The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial

MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function

SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of \>=22 is normal and \>=17 is considered mild ED

Patients without biochemical evidence of disease recurrence (i.e. postop PSA \>=0.2 ng/mL)

International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)

Henry Ford Health System

Director, Vattikuti Urology Institute

Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System

Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique

da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.

Control Arm

Retzius sparing radical prostatectomy da Vinci Surgical System

Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique

da Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.

Treatment Arm

Total

Age, Continuous

Sex: Female, Male

preoperative prostate specific antigen level

International Prostatic Symptom Score (IPSS) objectively assesses urinary symptoms. It ranges from 0 to 35, with higher scores indicating worse urinary symptoms

preoperative IPSS score

SHIM (Sexual Health Inventory for Men) objectively asses sexual function. It ranges from 0-25, with higher scores indicating better sexual function.

preoperative SHIM score

NCCN (National Comprehensive Cancer Network) risk categorizes prostate cancer based on their likelihood of disease progression, recurrence and outcomes, into low, intermediate, high and very high risk groups. It uses clinical information (i.e information available PRIOR to surgery) for this (i.e PSA, biopsy gleason score and clinical T stage)

NCCN clinical risk

Deepansh Dalela, MD

Urinary Continence Recovery

Number of Participants With Urinary Continence Recovery

Number of Participants With Peri and Postoperative Complications

Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)

Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)

Post-operative Urinary Function and Urinary Function-related Quality of Life

Number of Patients Who Regained Urinary Continence Postoperatively

The numbers in this analyses are different from the primary analyses as some patients were lost to follow up (by one year)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy	NCT06050057	Adrenal Tumor Adrenal Disease Adrenal Mass Adrenalectomy; ... Adrenal Hyperpl... Adrenal Gland M... Adrenal Cortex ... Pheochromocytom... Cushing Syndrom... Conn Adenoma Adrenocortical ... Adrenocortical ... Adrenocortical ...		18 Years -	University Hospital Olomouc
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery	NCT02352103	Urinary Inconti...	Retzius sparing... Vattikuti Urolo... da Vinci Surgic...	40 Years - 75 Years	Henry Ford Health System

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