Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy

Adrenal Tumors Clinical Trial

Official title:

Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Benign Adrenal Tumors Less Than 5 cm in Diameter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00713115
• Other study ID #: 200803040R
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2008
• Last updated: July 9, 2008
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2008
• Source: National Taiwan University Hospital
• Contact: Chun-Hou Liao, MD
• Phone: +886-2-23123456
• Email: liaoch22[@]so-net.net.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Benign Adrenal Tumors

Exclusion Criteria:

• Suspected adrenal malignancy clinically

• Bilateral adrenal disease

• Pregnant female

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Tumors

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis		1 month	Yes
Secondary	cost		1 month	No