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OpenTrials
Completed

NCT Number: NCT06064370

Side-specific Factors for Intraoperative Hemodynamic Instability in Pheochromocytoma

The performance of adrenalectomy for pheochromocytoma (PHEO) presents significant challenges due to the presence of elevated intraoperative hemodynamic instability (HI) and conversion risk. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of perioperative hypotension (HI) and conversion in left-sided (LLA) and right-sided (RLA) transabdominal laparoscopic adrenalectomy (TLA).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Pheochromocytoma (PHEO) is a malignancy characterized by the production of catecholamines from chromaffin cells located in the adrenomedullary system. The prevalence of PHEO in the general population ranges from 0.05% to 0.1%, however it is more prevalent among those with hypertension. The clinical presentation exhibits a spectrum that spans from asymptomatic to abrupt mortality. Minimally invasive laparoscopic adrenalectomy (LA) has emerged as a prominent technique in adrenal illness surgery due to its reduced surgical morbidity and death rates, making it the favored method in this field. The initial exploration of transperitoneal laparoscopic adrenalectomy (TLA) was conducted by Gagner et al. The LA procedure encompasses many transabdominal and retroperitoneal techniques, whereas TLA is favored by surgeons due to its well-known anatomy and expansive working area. Nevertheless, PHEO surgery remains a formidable task for surgeons and anesthesiologists due to its established correlation with hemodynamic instability (HI), resulting in symptoms such as abrupt hypertension or tachycardia, as well as severe and protracted hypotension following tumor excision. Skilled surgeons and anesthesiologists enhance the outcomes and reduce the occurrence of hypotension. The research has documented a multitude of additional risk factors associated with HI. The observed variability could perhaps be attributed to the lack of consistent anesthesiological and surgical protocols, as well as variations in the definitions of HI. Laparoscopic adrenalectomy does not have any absolute contraindications. However, it is worth noting that up to 20% of patients may need to undergo conversion to an open procedure. There has been no specific evaluation of the incidence and risk factors of perioperative hypotension (both intraoperative and postoperative) and conversion rate in a large group of patients undergoing laparoscopic right adrenalectomy (LRA) or laparoscopic left adrenalectomy (LLA) for managing pheochromocytoma resection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients >18 years, both sex with unilateral PHEO of any size who underwent TLA

Exclusion criteria

  • Patients who have undergone initial open adrenalectomy, various surgical procedures during total laparoscopic adrenalectomy (TLA), complete adrenalectomy,

bilateral PHEOS bleeding diathesis, skeletal deformity, pregnancy, previous homolateral abdominal surgery, missing data, questionable preoperative diagnosis, inherited PHEO, or recurrent PHEO.

Treatment and study plan

laparoscopic adrenalectomy

Procedure

laparoscopic adrenalectomy for pheochromocytoma

Primary outcomes

  1. hemodynamic instability

    Time frame: intraoperative and immediate postoperative

    incidence of hemodynamic instability

Secondary outcomes

  1. conversion rate

    Time frame: intraoperative

    incidence of conversion

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Side-specific Factors for Intraoperative Hemodynamic Instability in Adrenalectomy for Pheochromocytoma. A Comparative Analysis

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2023
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.