Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy
Primary Purpose
Adrenal Tumors
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
needlescopic adrenalectomy and laparoscopic adrenalectomy
Sponsored by
About this trial
This is an interventional treatment trial for Adrenal Tumors focused on measuring laparoscopy, needlescopy, adrenalectomy
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Benign Adrenal Tumors
Exclusion Criteria:
- Suspected adrenal malignancy clinically
- Bilateral adrenal disease
- Pregnant female
Sites / Locations
- National Taiwan University HospitalRecruiting
Outcomes
Primary Outcome Measures
Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis
Secondary Outcome Measures
cost
Full Information
NCT ID
NCT00713115
First Posted
July 9, 2008
Last Updated
July 9, 2008
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00713115
Brief Title
Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy
Official Title
Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Benign Adrenal Tumors Less Than 5 cm in Diameter
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Tumors
Keywords
laparoscopy, needlescopy, adrenalectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
needlescopic adrenalectomy and laparoscopic adrenalectomy
Other Intervention Name(s)
Miniscopic
Intervention 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.
Primary Outcome Measure Information:
Title
Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis
Time Frame
1 month
Secondary Outcome Measure Information:
Title
cost
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Benign Adrenal Tumors
Exclusion Criteria:
Suspected adrenal malignancy clinically
Bilateral adrenal disease
Pregnant female
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Hou Liao, MD
Phone
+886-2-23123456
Ext
5265
Email
liaoch22@so-net.net.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Chieh Chueh, MD. PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shih-Chieh Chueh, MD. PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
18164803
Citation
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.
Results Reference
background
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Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy
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