Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy

Overview

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.

Full Title of Study: “Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Benign Adrenal Tumors Less Than 5 cm in Diameter”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis
    • Time Frame: 1 month

Secondary Measures

  • cost
    • Time Frame: 1 month

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of Benign Adrenal Tumors Exclusion Criteria:

  • Suspected adrenal malignancy clinically – Bilateral adrenal disease – Pregnant female

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Shih-Chieh Chueh, Department of Urology, National Taiwan University Hospital
  • Overall Official(s)
    • Shih-Chieh Chueh, MD. PhD, Principal Investigator, National Taiwan University Hospital
  • Overall Contact(s)
    • Chun-Hou Liao, MD, +886-2-23123456, liaoch22@so-net.net.tw

References

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.

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