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NCT Number: NCT04071561

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

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.

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Key information

Conditions

Adrenal Tumor Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenal Hyperplasia Adrenal Hyperplasia, Congenital Adrenal Mass Adrenal Metastases Adrenocortical Adenoma Adrenogenital Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Conn Adenoma Disorders of Sex Development Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nutritional and Metabolic Diseases Paraganglioma Pheochromocytoma Steroid Metabolism, Inborn Errors Urogenital Abnormalities Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Simone Eichelberger

Basel, 4450, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients whose adrenal gland was removed with retroperitoneal access
  • Operation was between 01.07.2016 and 31.12.2018
  • Operation was at the Kantonsspital Aarau

Exclusion criteria

  • Patients with multivisceral resection

Treatment and study plan

Posterior retroperitoneal adrenalectomy (PRA)

Other

Minimally invasive adrenalectomy procedure

Lateral transperitoneal adrenalectomy (LTA)

Other

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

Primary outcomes

  1. Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

    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.

  2. Thickness of retroperitoneal fat

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

    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.

  3. Posterior Adiposity Index

    Time frame: The measurement of the parameter from the cross-sectional image was performed in the period from 19.11.2018 - 04.02.2019.

    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.

  4. Longitudinal distance between the upper pole of the kidney and the inferior border of the adrenal gland.

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

    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.

  5. Longitudinal distance between the superior border of the adrenal gland to the 12th rib tip.

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

    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.

  6. Longitudinal distance between the 12th rib and the iliac crest

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

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

  7. Sagittal thickness of the subcutaneous layer above the 12th rib tip

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

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

  8. Sagittal thickness of the subcutaneous layer above the iliac crest

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

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

  9. Thickness of the subcutaneous layer above the 12th rib tip

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

    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.

  10. Sagittal thickness of the subcutaneous layer between the center of gravity and the lateral border of the body

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

    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.

  11. Tumor size

    Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.

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

  12. Operative time

    Time frame: The data were collected between 19.11.2018 and 04.02.2019.

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

Secondary outcomes

  1. Body-Mass-Index

    Time frame: The data were collected between 19.11.2018 and 04.02.2019.

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

  2. The side of the adrenal gland that was removed

    Time frame: The data were collected between 19.11.2018 and 04.02.2019.

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

  3. Previously performed abdominal surgeries taken from the hospital information system

    Time frame: The data were collected between 19.11.2018 and 04.02.2019.

    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.

  4. Age

    Time frame: The data were collected between 19.11.2018 and 04.02.2019.

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

  5. Sex

    Time frame: The data were collected between 19.11.2018 and 04.02.2019.

    Female or Male

  6. Histological diagnosis of the sample from the adrenalectomy

    Time frame: The data were collected between 19.11.2018 and 04.02.2019.

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

  7. Imaging

    Time frame: The data were collected between 19.11.2018 and 04.02.2019.

    CT or MRI

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Collaborators

  • Kantonsspital Aarau

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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