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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04071561
Other study ID # 201901147
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 19, 2018
Est. completion date May 31, 2019

Study information

Verified date August 2019
Source University of Basel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Posterior retroperitoneal adrenalectomy (PRA)
Minimally invasive adrenalectomy procedure
Lateral transperitoneal adrenalectomy (LTA)
During posterior retroperitoneal adrenalectomy, the failure to progress or the difficulty of creating or maintaining a pneumoperitoneum are reasons why conversion occurs.

Locations

Country Name City State
Switzerland Simone Eichelberger Basel

Sponsors (2)

Lead Sponsor Collaborator
University of Basel Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip 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. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Thickness of retroperitoneal fat 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. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Posterior Adiposity Index 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. The measurement of the parameter from the cross-sectional image was performed in the period from 19.11.2018 - 04.02.2019.
Primary Longitudinal distance between the upper pole of the kidney and the inferior border of the adrenal gland. 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. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Longitudinal distance between the superior border of the adrenal gland to the 12th rib tip. 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. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Longitudinal distance between the 12th rib and the iliac crest Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the 12th rib and the iliac crest, mm. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Sagittal thickness of the subcutaneous layer above the 12th rib tip Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the 12th rib tip, mm. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Sagittal thickness of the subcutaneous layer above the iliac crest Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the iliac crest, mm. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Thickness of the subcutaneous layer above the 12th rib tip 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. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Sagittal thickness of the subcutaneous layer between the center of gravity and the lateral border of the body 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. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Tumor size Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Tumor size, cm. The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Primary Operative time Duration of adrenalectomy. Data were extracted and analyzed from the hospital information system. The data were collected between 19.11.2018 and 04.02.2019.
Secondary Body-Mass-Index Value derived from the mass (weight) and height of a person. Data were extracted and analyzed from the hospital information system. The data were collected between 19.11.2018 and 04.02.2019.
Secondary The side of the adrenal gland that was removed Side of the removed adrenal gland (left, right, bilateral). Data were extracted and analyzed from the hospital information system. The data were collected between 19.11.2018 and 04.02.2019.
Secondary Previously performed abdominal surgeries taken 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. The data were collected between 19.11.2018 and 04.02.2019.
Secondary Age Age at adrenalectomy. Data were extracted and analyzed from the hospital information system. The data were collected between 19.11.2018 and 04.02.2019.
Secondary Sex Female or Male The data were collected between 19.11.2018 and 04.02.2019.
Secondary Histological diagnosis of the sample from the adrenalectomy Histological evaluation. Data were extracted and analyzed from the hospital information system. The data were collected between 19.11.2018 and 04.02.2019.
Secondary Imaging CT or MRI The data were collected between 19.11.2018 and 04.02.2019.
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