NCT04071561

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

August 22, 2019

Last Update Submit

August 27, 2019

Conditions

Adrenal TumorAdrenal MassPheochromocytomaConn AdenomaAdrenal MetastasesAdrenal Hyperplasia

Keywords

AdrenalectomyMinimally invasive surgeryPosterior Retroperitoneoscopic adrenalectomyRetroperitoneal fat mass

Outcome Measures

Primary Outcomes (12)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (7)

  • Body-Mass-Index

    The data were collected between 19.11.2018 and 04.02.2019.

  • The side of the adrenal gland that was removed

    The data were collected between 19.11.2018 and 04.02.2019.

  • Previously performed abdominal surgeries taken from the hospital information system

    The data were collected between 19.11.2018 and 04.02.2019.

  • Age

    The data were collected between 19.11.2018 and 04.02.2019.

  • Sex

    The data were collected between 19.11.2018 and 04.02.2019.

  • +2 more secondary outcomes

Study Arms (2)

Non-conversion

In 13 patients, 14 posterior retroperitoneal adrenalectomy procedures were successfully completed and form the non-conversion group

Other: Posterior retroperitoneal adrenalectomy (PRA)

Conversion

Conversion to lateral transperitoneal adrenalectomy was necessary in 1 patient after starting posterior retroperitoneal adrenalectomy.

Other: Posterior retroperitoneal adrenalectomy (PRA)Other: Lateral transperitoneal adrenalectomy (LTA)

Interventions

Posterior retroperitoneal adrenalectomy (PRA)OTHER

Minimally invasive adrenalectomy procedure

ConversionNon-conversion
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.

Conversion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent posterior retroperitoneal adrenalectomy at Kantonsspital Aarau.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with multivisceral resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simone Eichelberger

Basel, 4450, Switzerland

Location

MeSH Terms

Conditions

Adrenal Gland NeoplasmsPheochromocytomaAdrenocortical AdenomaAdrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Gland DiseasesEndocrine System DiseasesParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueAdrenal Cortex NeoplasmsAdrenal Cortex DiseasesAdrenogenital SyndromeDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSteroid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesGonadal Disorders

Study Officials

  • Christian A Nebiker, PD Dr. med.

    Kantonsspital Aarau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMed

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

November 19, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

CH(1)