NCT06064370

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

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

September 1, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

7 years

First QC Date

September 26, 2023

Last Update Submit

June 9, 2024

Conditions

adrenalDisease

Outcome Measures

Primary Outcomes (1)

  • hemodynamic instability

    incidence of hemodynamic instability

    intraoperative and immediate postoperative

Secondary Outcomes (1)

  • conversion rate

    intraoperative

Study Arms (2)

laparoscopic right adrenalectomy

laparoscopic right adrenalectomy for pheochromocytoma

Procedure: laparoscopic adrenalectomy

laparoscopic left adrenalectomy

laparoscopic left adrenalectomy for pheochromocytoma

Procedure: laparoscopic adrenalectomy

Interventions

laparoscopic adrenalectomyPROCEDURE

laparoscopic adrenalectomy for pheochromocytoma

laparoscopic left adrenalectomylaparoscopic right adrenalectomy

Eligibility Criteria

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

A total of 271 patients (n = 271) were involved in the study and subsequently separated into two groups: LRA (n = 122) and LLA (n = 149).

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professour of general and laparoscopic surgery

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

September 1, 2016

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share