Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy
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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 |
- Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- 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) |
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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, 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 |
Inclusion Criteria:
- Clinical diagnosis of Benign Adrenal Tumors
Exclusion Criteria:
- Suspected adrenal malignancy clinically
- Bilateral adrenal disease
- Pregnant female
Contacts and Locations| 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 |
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 May 23, 2013