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

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

Detailed Description
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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.

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

Conditions
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Adrenal; Functional Disturbance, Retroperitoneal Sarcoma, Intraoperative Hypotension

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Cortisol peak after low dose Synachten stimulation test. | Assessment of early postoperative acute adrenal dysfunction. | 1st postoperative day | 
| Serum Cortisol peak after low dose Synachten stimulation test. | Assessment of postoperative acute adrenal dysfunction. | 10th postoperative day | 
| Serum Cortisol peak after low dose Synachten stimulation test. | Assessment of postoperative chronic adrenal dysfunction. | 4 months after surgery (only if test positive on 10th postoperative day) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retroperitoneal Sarcoma, Surgery, Haemodynamic assessment, Adrenalectomy