Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00713115
First received: July 9, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Adrenal Tumors
Procedure: needlescopic adrenalectomy and laparoscopic adrenalectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Benign Adrenal Tumors Less Than 5 cm in Diameter

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cost [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: needlescopic adrenalectomy and laparoscopic adrenalectomy
    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.
    Other Name: Miniscopic
Detailed Description:

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, and thus better cosmesis. It may further reduce postoperative pain, hospital stay, and recovery time.

All operations were performed with the lateral transperitoneal approach. A 12-mm port was created near the umbilicus for a 30-degree telescope, and another two(for left lesions) or three (for right lesions) 2-mm working ports (Tyco Healthcare, Norwalk, Connecticut, USA) were created along the ipsilateral subcostal region. Careful dissection was done with the use of a 2-mm hook or scissors electrocoagulator. The adrenal vein of the lesion side was isolated and controlled with a 2-mm mini-bipolar coagulation apparatus (Tyco Healthcare) for a long segment. The vein was then transected closer to the adrenal gland, leaving the coagulated stump at the renal vein or vena cava as long as possible, even when a short right adrenal vein was encountered. Then the adrenal gland with the tumor was dissected from its surrounding tissues after several tiny vessels were transected with the needlescopic instruments mentioned above. The specimen was put into a retrieval bag and removed through the umbilical port.

  Eligibility

Ages Eligible for Study:   3 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Benign Adrenal Tumors

Exclusion Criteria:

  • Suspected adrenal malignancy clinically
  • Bilateral adrenal disease
  • Pregnant female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713115

Contacts
Contact: Chun-Hou Liao, MD +886-2-23123456 ext 5265 liaoch22@so-net.net.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shih-Chieh Chueh, MD. PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shih-Chieh Chueh, MD. PhD National Taiwan University Hospital
  More Information

Publications:
Responsible Party: Shih-Chieh Chueh, Department of Urology, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00713115     History of Changes
Other Study ID Numbers: 200803040R
Study First Received: July 9, 2008
Last Updated: July 9, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
laparoscopy, needlescopy, adrenalectomy

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014