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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00713115 |
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 |
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Adrenal Tumors |
Procedure: needlescopic adrenalectomy and laparoscopic adrenalectomy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Benign Adrenal Tumors Less Than 5 cm in Diameter |
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) |
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.
Ages Eligible for Study: | 3 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chun-Hou Liao, MD | +886-2-23123456 ext 5265 | liaoch22@so-net.net.tw |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Shih-Chieh Chueh, MD. PhD |
Principal Investigator: | Shih-Chieh Chueh, MD. PhD | National Taiwan University Hospital |
Responsible Party: | Department of Urology, National Taiwan University Hospital ( Shih-Chieh Chueh ) |
Study ID Numbers: | 200803040R |
Study First Received: | July 9, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00713115 History of Changes |
Health Authority: | Taiwan: Department of Health |
laparoscopy, needlescopy, adrenalectomy |
Adrenal Gland Neoplasms Endocrine System Diseases Adrenal Gland Diseases |
Endocrinopathy Epinephrine Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adrenal Gland Neoplasms |
Endocrine System Diseases Adrenal Gland Diseases Endocrine Gland Neoplasms |