Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas

Evaluation of Perioperative Residual Adrenal Function After Extended Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04225494

Acronym

RAF

Enrollment

Registered

2020-01-13

Start date

2019-06-01

Completion date

2021-05-21

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal; Functional Disturbance, Intraoperative Hypotension, Retroperitoneal Sarcoma

Keywords

Retroperitoneal Sarcoma, Surgery, Haemodynamic assessment, Adrenalectomy

Brief summary

Early recognition of adrenal function deficit in patients undergoing multivisceral surgery including adrenalectomy for primitive retroperitoneal sarcomas

Detailed description

The extended multivisceral resection of retroperitoneum is the standard treatment for primary retroperitoneal soft tissue sarcomas. This procedure also includes the removal of the healthy adrenal gland ipsilateral to the tumor site. The investigators think that a such extended surgical approach together with the removal of the adrenal gland may lead to a state of acute adrenal insufficiency and related hemodynamic instability. In order to recognize this condition the investigators use a low dose ACTH test (Synacthen test) during the 1° and 10° post-operative days.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients (age\> 18 years) * Diagnosis of retroperitoneal sarcoma * Adrenalectomy enbloc included in multivisceral resection * Voluntary informed written consent

Exclusion criteria

* Recurrent and / or metastatic disease * Patient chronically treated with corticosteroids * Primary disorders of adrenal gland * Basal serum cortisol values ≤ 7 µg / dL * Clinically significant heart disease * Altered TSH

Design outcomes

Primary

Measure	Time frame	Description
Serum Cortisol peak after low dose Synachten stimulation test.	1st postoperative day	Assessment of early postoperative acute adrenal dysfunction.

Secondary

Measure	Time frame	Description
Postoperative morbidity	30th postoperative day	Correlation between morbidity according to Clavien-Dindo and postoperative adrenal dysfunction
Vasoactive inotropic score	Intraoperatively and up to 3rd postoperative day	Correlation between intra- and postoperative usage of vasoactive drugs and postoperative adrenal dysfunction

Countries

Italy

Outcome results