Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy
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|ClinicalTrials.gov Identifier: NCT00713115|
Recruitment Status : Unknown
Verified June 2008 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : July 11, 2008
Last Update Posted : July 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Adrenal Tumors||Procedure: needlescopic adrenalectomy and laparoscopic adrenalectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Benign Adrenal Tumors Less Than 5 cm in Diameter|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
Procedure: needlescopic adrenalectomy and laparoscopic adrenalectomy
- Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis [ Time Frame: 1 month ]
- cost [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713115
|Contact: Chun-Hou Liao, MD||+886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Contact: Shih-Chieh Chueh, MD. PhD|
|Principal Investigator:||Shih-Chieh Chueh, MD. PhD||National Taiwan University Hospital|