- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04071561
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Basel, Switzerland, 4450
- Simone Eichelberger
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-conversion
In 13 patients, 14 posterior retroperitoneal adrenalectomy procedures were successfully completed and form the non-conversion group
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Minimally invasive adrenalectomy procedure
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Conversion
Conversion to lateral transperitoneal adrenalectomy was necessary in 1 patient after starting posterior retroperitoneal adrenalectomy.
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Minimally invasive adrenalectomy procedure
During posterior retroperitoneal adrenalectomy, the failure to progress or the difficulty of creating or maintaining a pneumoperitoneum are reasons why conversion occurs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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Thickness of retroperitoneal fat
Time Frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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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.
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The measurement of the parameter from the cross-sectional image was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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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.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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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.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI).
Longitudinal distance between the 12th rib and the iliac crest, mm.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI).
Sagittal thickness of the subcutaneous layer above the 12th rib tip, mm.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI).
Sagittal thickness of the subcutaneous layer above the iliac crest, mm.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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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.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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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.
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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.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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Tumor size
Time Frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI).
Tumor size, cm.
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The measurement was performed in the period from 19.11.2018 - 04.02.2019.
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Operative time
Time Frame: The data were collected between 19.11.2018 and 04.02.2019.
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Duration of adrenalectomy.
Data were extracted and analyzed from the hospital information system.
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The data were collected between 19.11.2018 and 04.02.2019.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body-Mass-Index
Time Frame: The data were collected between 19.11.2018 and 04.02.2019.
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Value derived from the mass (weight) and height of a person.
Data were extracted and analyzed from the hospital information system.
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The data were collected between 19.11.2018 and 04.02.2019.
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The side of the adrenal gland that was removed
Time Frame: The data were collected between 19.11.2018 and 04.02.2019.
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Side of the removed adrenal gland (left, right, bilateral).
Data were extracted and analyzed from the hospital information system.
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The data were collected between 19.11.2018 and 04.02.2019.
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Previously performed abdominal surgeries taken from the hospital information system
Time Frame: The data were collected between 19.11.2018 and 04.02.2019.
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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.
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The data were collected between 19.11.2018 and 04.02.2019.
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Age
Time Frame: The data were collected between 19.11.2018 and 04.02.2019.
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Age at adrenalectomy.
Data were extracted and analyzed from the hospital information system.
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The data were collected between 19.11.2018 and 04.02.2019.
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Sex
Time Frame: The data were collected between 19.11.2018 and 04.02.2019.
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Female or Male
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The data were collected between 19.11.2018 and 04.02.2019.
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Histological diagnosis of the sample from the adrenalectomy
Time Frame: The data were collected between 19.11.2018 and 04.02.2019.
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Histological evaluation.
Data were extracted and analyzed from the hospital information system.
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The data were collected between 19.11.2018 and 04.02.2019.
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Imaging
Time Frame: The data were collected between 19.11.2018 and 04.02.2019.
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CT or MRI
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The data were collected between 19.11.2018 and 04.02.2019.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian A Nebiker, PD Dr. med., Kantonsspital Aarau
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Endocrine Gland Neoplasms
- Genetic Diseases, Inborn
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Metabolism, Inborn Errors
- Neuroendocrine Tumors
- Adrenal Gland Diseases
- Steroid Metabolism, Inborn Errors
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Paraganglioma
- Adenoma
- Hyperplasia
- Adrenal Hyperplasia, Congenital
- Adrenogenital Syndrome
- Pheochromocytoma
- Adrenocortical Adenoma
Other Study ID Numbers
- 201901147
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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