Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Adrenal Gland Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Endocrine System Diseases

Renal Cell Carcinoma

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

patients underwent to laparoscopic renal and adrenal surgery with intraoperative complications

patients underwent to laparoscopic renal and adrenal surgery with no complication during surgical procedure

type of treatment for patients underwent to laparoscopic surgery for renal and adrenal diseases with intraoperative complications

laparoscopic surgery for renal and adrenal diseases

Giuseppe Di Buono, Medicine

Antonino Agrusa, Medicine

the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.

Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS)

Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study

evaluation of intraoperative complication and their resolution

Fundacio Puigvert

University of Palermo

full professor of surgery

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Carcinoma

Adenoma

Neoplasm Metastasis

Syndrome

Cushing Syndrome

Pheochromocytoma

Hyperplasia

Adrenocortical Adenoma

Adrenocortical Carcinoma

Adrenal Gland Neoplasms

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

Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

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

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.

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Liver Extracts

Pancrelipase

Pancreatin

Cola

patient had posterior retroperitoneoscopic adrenalectomy

patient had Transperitoneal laparoscopic adrenalectomy

Patient is in prone, half Jack-knife position, and hips and knees are fixed in 75-90°. A 15 mm trocar incision just below the tip 12th rib. Prepare a small retroperitoneal space with finger and insert two 5 mm trocars about 5 cm lateral and medial to the first trocar with digital guidance. Medial trocar will be inserted upward. Lateral one will be lateral and below the 11th rib. Dissect inferior to diaphragm and retraction of the kidney downward. Mobilize the adrenal gland. At right side, start medial and caudally. Control the adrenl arteries crossing the IVC posteriorly. Prepare adrenal vein posterolaterally. Control between two clips. Continue gland dissection laterally and cranially. At left side, prepare the adrenal vein between the gland and diaphragm medial to the upper pole of the kidney. Dissect medial, lateral and cranially. Retrieve the mass through middle incision. Insert a drain and close skin incisions (Walz M. K., 2005).

Posterior retroperitoneoscopic adrenalectomy

On right side, patient is on supine position. Put a trocar at umbilicus for the camera. Put 4 trocars 1-2 cm subcostal from subxiphoid (10-12 mm) for liver retractor, to far lateral (5 mm) and two 10 mm trocars inbetween. Retract liver, incise the retroperitoneum, and identify right adrenal gland between upper pole of the kidney and IVC. Dissect gland from the kidney than laterally and posteriorly from the diaphragm. Expose, apply clips to, and divide the adrenal vein. On left side, patient is on lateral decubitus. Put a trocar at umbilicus for the camera, 4 trocars 1-2 cm subcostal from the midline to the far most lateral possible (the last is 5 mm the rest are 10 mm). Mobilize colon flexure and expose the kidney. Separate kidney from the pancreas and spleen. Mobilize the tumor, starting by posterior surface, superior border then from the renal surface. Divide the adrenal vein. Retrieve the mass (Suzuki, Tsuru, \& Ihara, 2012; Linos, 2005; George \& Kavoussi, 2010).

Transperitoneal laparoscopic adrenalectomy

Sami M Shaaban, Professor

Haitham M Badawy, PhD

Tamer H Abou-Youssif, PhD

This randomized comparative study assesses the safety and efficacy of the posterior retroperitoneoscopic adrenalectomy in comparison to the standard, anterior transperitoneal approach and suppose that this new technique is a safe and effective alternative to the standard approach.

Aim of the study:

To upgrade the urosurgical care level for candidate of surgical adrenalectomy due to adrenal diseases, to increase efficacy of the procedure and shorten the operative time and duration of hospital stay and convalescence.

Study Objective:

Comparing the safety and efficacy of posterior retroperitoneoscopic versus anterior transperitoneal adrenalectomy, as regard to the operative time, estimated intraoperative blood loss, days of postoperative hospital stay, and rate of complications.

Study Question:

Can the posterior retroperitoneoscopic approach provide a better alternative to anterior laparoscopic approach in terms of effectiveness and safety for laparoscopic adrenalectomy?

Study Hypothesis:

Investigators suggest that posterior retroperitoneoscopic approach is a safe and effective alternative to anterior transperitoneal approach for adrenalectomy with less operative time, estimated blood loss, postoperative days of hospitalization and rate of complications.

Significance and Relevance:

This study is suspected to be beneficial for urologists and oncology surgeons, as they can select the most effective intervention for patients with adrenal disease.

Study setting:

The study will be carried out over one year starting from 4/2015 to 5/2016, including the operations and data management. Operative procedures will be carried out at Urology Departments on Suez Canal, and Alexandria University hospitals.

Study population The study will focus on patients with adrenal disease indicated for adrenalectomy. The sample frame will include patients of any age, gender and body weight, with fair cognitive function, who is candidate for simple laparoscopic adrenalectomy in Suez Canal University Hospital and Alexandria University Hospital. Inclusion and exclusion criteria will be mentioned at Eligibility section.

Sampling:

A non-probability convenience sample will be taken. That is the cases present and referred to urology clinic and diagnosed to have adrenal mass or hyperplasia and are candidates for laparoscopic adrenalectomy.

The sample size will be calculated to compare mean values of two independent groups of equal sizes with a possibility of two way outcome. The sample size will be 20 cases, randomly divided into 10 cases for each group.

Work plan:

The main objective of the study is to compare the data related obtained in the two laparoscopic approachs in order to assess the efficacy of each one and determine a statistic evidence of preferring one of them over the other. This goal could be achieved through the following steps. First, patient evaluation; and this will be through the urology clinic of the university hospitals in Suez Canal and Alexandria Universities. It also includes patients referred from related clinics of oncosurgery, gynecology, endocrinology and cardiology clinics. History taking, full clinical examination will be done. Laboratory investigations will be requested according to provisional clinical diagnosis. Imaging studies will be done to confirm final diagnosis and determine the treatment plan. Second, as the case is indicated and fit for laparoscopic adrenalectomy, and as the case fulfill the inclusion criteria of the study, the patient will get a study number and will be randomly assigned to each operative approach. Third phase of the study is postoperative follow up. The patient will be followed for a month. Parameters will include the postoperative days to full diet, days to mobilization, days to discharge and days to full recovery. Also the postoperative pain score and the scar cosmetic outcome are included.

Instruments:

The theatre room should be prepared for laparoscopic procedure with: a charge-coupled device video camera, a video monitor, Xenon light source, high frequency generator and suction and irrigation devices. Laparoscopic surgeries depend on five main steps. Insufflation using CO2 high flow insufflator. This step involve 2 techniques; the closed techniques with Veress needle in transperitoneal access; and the open Hasson techniques. Trocar insertion that include the multiport type, open or closed technique, retroperitoneal and transperitoneal. Dissection through abdominal planes will need endoscopic curved scissors with or without rotatable blades, endoscopic curved dissectors and suction irrigation probe. Also the procedure may include sharp dissection with endoshears or blunt dissection with endo-peanuts, right angle dissector. Upon heamostasis the basic instruments are: 5 mm monopolar coagulation forceps/dissector, 5 mm bipolar forceps, 10 mm endoclip applicator and endoscopic staplers. LigaSure™ for blunt dissection and heamostasis. Endoscopic needle holder and short threaded small needle are needed for suturing. Finally, the LapSac™ is the best tested bag for retrieval of specimens. The data of the patient and his preoperative and postoperative parameters will be collected by a questionnaire designed for the purposes of this study. It also include the traditional numerical rating scale and visual analogue scale for assessment of the postoperative pain. The patient satisfaction of the scar will be assessed by three questionnaires; body image questionnaire, photo series questionnaire and future surgical procedure preference questionnaire.

Variables:

For each case the data will include demographic data of the patient and his medical and surgical history. This includes age, gender, body mass index calculated as kg/square meter. The side of the affected gland plays a role in operative time, so determination of the side by computed tomography (CT) is essential. Also size of the adrenal mass in CT and the clinical diagnosis regarding the function and the possibility of malignancy will also be considered the main independent variable. A significant independent variable is the surgeon's experience. The number and type of the procedures done by the operator with rate and cause of conversions will be included to each case. Dependent variables will include the full operative data of each case. Starting from the indication of the intervention and the rationale for preference of laparoscopic approach and eventually the cause of conversion if needed. This study focuses on operative time in minutes; total time from the first abdominal incision to the last suture, and the time elapsed to identify the adrenal vein, a critical step at the operation. The study is also interested in comparing the estimated blood loss measured in milliliters and the correlation to the type of tumor, patients and operative variables. On the postoperative phase, the data gathered include the number of days to full diet, of post-operative hospital stay and to complete recovery; i.e. return to usual daily activity. The patient will achieve a score assessment of the postoperative pain and assessment of cosmotic outcome of the incisions. The rate of short term complications postoperatively will be assessed for each group and classified by Clavien-Dindo system.

Statistical Analysis:

This will include data management and coding. The data entry will be via SPSS™ or Microsoft™ Excel™. Mainly the comparison of the study variables will be via detecting the significance of differences between mean values of each group parameters. Finally, the data will be arranged into tables and graphs and presented to conclude the findings of the study.

Ethical consideration:

All patients are informed about participation in training course for urology trainees as a part of the consent of admission and getting surgical intervention at an authorized teaching hospital. However, each participant will be offered an informed consent for being included into this comparative study. The patient will receive his ideal and best line of treatment according to the latest guidelines and available facilities whatever his response to the consent. The risk of complications of both intervention is comparable and all participants will have the same chance to have either transperitoneal or posterior retroperitoneal approaches. To avoid bias, patient will be assigned randomly into the two study groups. At the other hand, patient's data involved at this study will be treated confidentially.

Budget:

This study is funded by the researcher's financial resources. That includes transportation fees, paper work and audio-video utilities. Cases done in the Suez Canal University Hospital may be afforded by the college or the hospital fund. This includes the admission, the rent of the laparoscopic set and the associated medications.

Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative Study

Posterior Retroperitoneoscopic Approach Versus Transperitoneal Laparoscopic Approach in Management of Adrenal Tumors: A Randomized Comparative Study

total time from the first abdominal incision to the last suture, and the time elapsed to identify the adrenal vein, a critical step at the operation.

include the number of days to full diet, to mobilization and to complete recovery; i.e. return to usual daily activity.

classified by Clavien-Dindo classification system

using visual analogue scale or face scale score (according to participant's level of education)

The patient satisfaction of the scar will be assessed by THE SUM of scores of three questionnaires; body image questionnaire score + photo series questionnaire score + future surgical procedure preference questionnaire score

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS)	NCT05322265	Adrenal Disease Renal Cancer Surgery--Compli...	laparoscopic su...	18 Years - 89 Years	University of Palermo
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
Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative Study	NCT02618694	Adrenal Mass Adrenal Disease Pheochromocytom... Cushing Syndrom...	Posterior retro... Transperitoneal...	-	Suez Canal University

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