NCT00713115

Brief Summary

The study is a prospective radonmized comparison between needlescopic adrenalectomy and conventional laparoscopic adrenalectomy for benign adrenal tumors less than 5 cm. The operative success rate, operative time, intraoperative blood loss, intraoperative or postoperative complication, postoperative pain, postoperative hospital stay, convalescence, and wound cosmesis were compared.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 11, 2008

Status Verified

June 1, 2008

Enrollment Period

2.5 years

First QC Date

July 9, 2008

Last Update Submit

July 9, 2008

Conditions

Adrenal Tumors

Keywords

laparoscopy, needlescopy, adrenalectomy

Outcome Measures

Primary Outcomes (1)

  • Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis

    1 month

Secondary Outcomes (1)

  • cost

    1 month

Interventions

needlescopic adrenalectomy and laparoscopic adrenalectomyPROCEDURE

Needlescopic instruments, defined as those with a diameter of no more than 3 mm. They result in smaller incisions than conventional 5- to 12-mm instruments.

Also known as: Miniscopic

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Benign Adrenal Tumors

You may not qualify if:

  • Suspected adrenal malignancy clinically
  • Bilateral adrenal disease
  • Pregnant female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • Liao CH, Lai MK, Li HY, Chen SC, Chueh SC. Laparoscopic adrenalectomy using needlescopic instruments for adrenal tumors less than 5cm in 112 cases. Eur Urol. 2008 Sep;54(3):640-6. doi: 10.1016/j.eururo.2007.12.028. Epub 2007 Dec 26.

    PMID: 18164803BACKGROUND

MeSH Terms

Conditions

Adrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Shih-Chieh Chueh, MD. PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Hou Liao, MD

CONTACT

+886-2-23123456liaoch22@so-net.net.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 11, 2008

Record last verified: 2008-06

Locations

TW(1)