I Hemodynamic Instability and Conversion in Adrenalectomy for Management

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT06064370
Collaborator
(none)
171
84

Study Details

Study Description

Brief Summary

Adrenalectomy for pheochromocytoma (PHEO) is challenging because of the high intraoperative hemodynamic instability (HI) and conversion risk. This study aimed to compare the incidence and risk factors of perioperative HI and conversion between left-sided (LLA) and right-sided (RLA) transabdominal laparoscopic adrenalectomy (TLA).

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic adrenalectomy

Detailed Description

Pheochromocytoma (PHEO) is an adrenomedullary chromaffin cell tumour that releases catecholamines . The general population incidence of PHEO is 0.05%-0.1%; however, it is higher in the hypertensive population. Clinical presentation ranges from asymptomatic to sudden death . Emerging technologies have evolved to include minimally invasive laparoscopic adrenalectomy(LA), which has become the preferred method in adrenal disease surgery with lower surgical morbidity and mortality. Gagner et al. were the first to discuss transperitoneal laparoscopic adrenalectomy (TLA) . The LA technique includes many different transabdominal and retroperitoneal approaches, while many surgeons prefer TLA because of its familiar anatomy and large working space . However, PHEO surgery is still challenging for surgeons and anesthesiologists because it has been proven to be associated with hemodynamic instability(HI) and presents with sudden hypertension or tachycardia or severe and prolonged hypotension after tumour removal . Trained surgeons and anesthesiologists optimize the results and minimize HI . Numerous other risk factors for HI have been reported in the literature . The diversity might be due to unstandardized anesthesiological and surgical management and different HI definitions. There are no absolute contraindications for laparoscopic adrenalectomy; however, as many as 20% of patients require conversion to an open. Variations in patient outcomes during laparoscopic right adrenalectomy(LRA) or laparoscopic left adrenalectomy(LLA) for managing pheochromocytoma resection have never been evaluated specifically in terms of incidence and risk factors of perioperative HI (intraoperative and postoperative) and conversion rate in a large cohort of patients.

Study Design

Study Type:
Observational
Actual Enrollment :
171 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Incidence and Risk Factors of Perioperative Hemodynamic Instability and Conversion in Right and Left Sided Transabdominal Adrenalectomy for Management of Pheochromocytoma. Retrospective Comparative Study.
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Sep 1, 2023
Actual Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
laparoscopic right adrenalectomy

laparoscopic right adrenalectomy for pheochromocytoma

Procedure: laparoscopic adrenalectomy
laparoscopic adrenalectomy for pheochromocytoma

laparoscopic left adrenalectomy

laparoscopic left adrenalectomy for pheochromocytoma

Procedure: laparoscopic adrenalectomy
laparoscopic adrenalectomy for pheochromocytoma

Outcome Measures

Primary Outcome Measures

  1. hemodynamic instability [intraoperative and immediate postoperative]

    incidence of hemodynamic instability

Secondary Outcome Measures

  1. conversion rate [intraoperative]

    incidence of conversion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients >18 years, both sex with unilateral PHEO of any size who underwent TLA
Exclusion Criteria:
  • . Patients with first-line open adrenalectomy, other surgical procedures during TLA, partial adrenalectomy, bilateral PHEOS, bleeding diathesis, skeletal deformity, pregnancy, previous homolateral abdominal surgery, missing data, uncertain preoperative diagnosis, hereditary PHEO, or recurrent PHEO

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tamer.A.A.M.Habeeb, professour of general and laparoscopic surgery, Zagazig University
ClinicalTrials.gov Identifier:
NCT06064370
Other Study ID Numbers:
  • adrenalectomy
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 3, 2023