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Hyperadrenalism

Posterior retroperitoneoscopic adrenalectomy

Lateral transperitoneal laparoscopic adrenalectomy

Posterior RA

Lateral transperitoneal LA

Marcin Barczyński, MD, PhD

Laparoscopic adrenalectomy has become the gold standard operation for non-malignant adrenal tumors replacing open adrenalectomy. The most popular lateral transperitoneal laparoscopic adrenalectomy (LTLA) approach has been recently challenged by an increasing popularity of the posterior retroperitoneoscopic adrenalectomy (PRA) approach which is believed by many surgeons as an easy to learn, reproducible and beneficial for patients. However, this belief is not evidence-based, so far. The aim of this study is to clarify if PRA is superior to the LTLA as minimally invasive approach to small and benign adrenal tumors.

Laparoscopic adrenalectomy has replaced open adrenalectomy as the standard operation for non-malignant adrenal tumours. Thanks to the popularization of the posterior technique described by Walz and co-workers, the posterior retroperitoneal adrenalectomy (PRA) is being performed in increasing numbers worldwide. Advocates for the laparoscopic and retroperitoneoscopic approaches cite the advantages of each technique, but there is no published evidence that supports the superiority of one over the other. Most of the published literature is retrospective, with inadequate or no controls and with potential biases.

The aim of this study is to test the hypothesis that PRA is superior to the lateral transperitoneal laparoscopic adrenalectomy (LTLA) as minimally invasive approach to small and benign adrenal tumors.

For a sample size calculation an assumption was made that a 20% reduction in duration of surgery represents clinically relevant difference. To detect this, it was calculated that 24 patients would be required in each treatment arm to give the study a power of 90 per cent. Anticipating a 25% loss to follow-up, 32 patients per arm were required in the study.

Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy

Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Transperitoneal Laparoscopic Adrenalectomy With a Five-year Follow-up

including: postoperative pain, length of hospital stay, time to oral intake, time to ambulation

including: pneumothorax/haemothorax, surgical emphysema, chest infection, visceral injury, peritonitis/abscess, wound infection, neuralgia, and surgical access site herniation

Jagiellonian University

Associate Professor of Surgery at the Third Chair of General Surgery

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Neoplasm Metastasis

Adenoma

Hyperplasia

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Adrenocortical Adenoma

Neoplasms, Glandular and Epithelial

Disorders of Sex Development

Congenital Abnormalities

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Female Urogenital Diseases and Pregnancy Complications

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Gonadal Disorders

Adrenal Cortex Neoplasms

Adrenal Cortex Diseases

Oculocerebral Syndrome With Hypopigmentation

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Adenoma of the Adrenal Gland

In 13 patients, 14 posterior retroperitoneal adrenalectomy procedures were successfully completed and form the non-conversion group

Conversion to lateral transperitoneal adrenalectomy was necessary in 1 patient after starting posterior retroperitoneal adrenalectomy.

Minimally invasive adrenalectomy procedure

Posterior retroperitoneal adrenalectomy (PRA)

During posterior retroperitoneal adrenalectomy, the failure to progress or the difficulty of creating or maintaining a pneumoperitoneum are reasons why conversion occurs.

Lateral transperitoneal adrenalectomy (LTA)

Christian A Nebiker, PD Dr. med.

With our retrospective study the investigators show the limitations of the posterior retroperitoneal adrenalectomy by analyzing anatomical parameters.

The investigators compared the data from one patient who underwent a conversion with 13 patients without a conversion. Furthermore, they explored the influence of these parameters on the operation time and excluded the patient who had a conversion from this analysis.

The investigators hypothesize that by determining anatomical characteristics on cross-sectional imaging (CT or MRI), they can show the limitations of the posterior retroperitoneal adrenalectomy to prevent patients from being converted to lateral transperitoneal adrenalectomy.

Minimally invasive adrenalectomy has become the gold standard for the surgical treatment of small, benign adrenal lesions. In addition to the common laparoscopic lateral transperitoneal adrenalectomy, the posterior retroperitoneal adrenalectomy is becoming increasingly important.

To date, there is no consensus regarding the preferred approach in the resection of benign adrenal tumors. A comprehensive adrenal tumor program should be able to offer both options, however, patient selection criteria for a given approach have not yet been defined. The choice between lateral transperitoneal adrenalectomy and posterior retroperitoneal adrenalectomy is relevant for patients with unilateral tumors \< 6-7 cm and without previous abdominal surgery.

The aim of this study was to determine the limits of posterior retroperitoneal adrenalectomy using anatomical parameters to enable the preferred access to be chosen preoperatively to prevent conversion. In addition, the investigators describe the relationship between these parameters and the operation time to find a measure of the degree of technical difficulty.

Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions

Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions on Cross-sectional Imaging (CT or MRI)

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Defined as the largest distance between the kidney parenchyma and the posterior abdominal wall at the level where the renal vein joins the vena cava inferior.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Distance from skin to renal parenchyma through the 12th rib tip. The larger the distance, the larger the index. The scale ranges are open.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the upper pole of the kidney and the inferior border of the adrenal gland, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the superior border of the adrenal gland to the 12th rib tip, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the 12th rib and the iliac crest, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the 12th rib tip, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the iliac crest, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Thickness of the subcutaneous layer above the 12th rib tip, measured on the straight line to the center of gravity, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer between the center of gravity and the lateral border of the body, measured at the level of the 12th rib tip, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Tumor size, cm.

Duration of adrenalectomy. Data were extracted and analyzed from the hospital information system.

Value derived from the mass (weight) and height of a person. Data were extracted and analyzed from the hospital information system.

Side of the removed adrenal gland (left, right, bilateral). Data were extracted and analyzed from the hospital information system.

Previous abdominal operations with opening of the abdominal cavity which give an indication of adhesions.Data were extracted and analyzed from the hospital information system.

Age at adrenalectomy. Data were extracted and analyzed from the hospital information system.

Histological evaluation. Data were extracted and analyzed from the hospital information system.

Kantonsspital Aarau

University of Basel

BMed

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Epinephrine

Liver Extracts

Pancrelipase

Racepinephrine

Epinephryl borate

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).

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
Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy	NCT01959711	Adrenal Tumor Pheochromocytom... Conn's Syndrome Cushing's Syndr...	Posterior RA Lateral transpe...	18 Years - 80 Years	Jagiellonian University
Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions	NCT04071561	Adrenal Tumor Adrenal Mass Pheochromocytom... Conn Adenoma Adrenal Metasta... Adrenal Hyperpl...	Posterior retro... Lateral transpe...	18 Years -	University of Basel
Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions	NCT04071561	Adrenal Tumor Adrenal Mass Pheochromocytom... Conn Adenoma Adrenal Metasta... Adrenal Hyperpl...	Posterior retro... Lateral transpe...	18 Years -	University of Basel
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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