Pheochromocytoma Clinical Trial
Official title:
Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions on Cross-sectional Imaging (CT or MRI)
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 |
Verified date | August 2019 |
Source | University of Basel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Simone Eichelberger | Basel |
Lead Sponsor | Collaborator |
---|---|
University of Basel | Kantonsspital Aarau |
Switzerland,
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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