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

Pheochromocytoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071561
• Other study ID #: 201901147
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Adenoma
• Adrenal Hyperplasia
• Adrenal Hyperplasia, Congenital
• Adrenal Mass
• Adrenal Metastases
• Adrenal Tumor
• Adrenocortical Adenoma
• Adrenogenital Syndrome
• Conn Adenoma
• Hyperplasia
• Pheochromocytoma

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.