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


N/A
3 Years
80 Years
Open (Enrolling)
Both
Adrenal Tumors

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Trial Information

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


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.


Inclusion Criteria:



- Clinical diagnosis of Benign Adrenal Tumors

Exclusion Criteria:

- Suspected adrenal malignancy clinically

- Bilateral adrenal disease

- Pregnant female

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Shih-Chieh Chueh, MD. PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

200803040R

NCT ID:

NCT00713115

Start Date:

June 2008

Completion Date:

December 2010

Related Keywords:

  • Adrenal Tumors
  • laparoscopy, needlescopy, adrenalectomy
  • Adrenal Gland Neoplasms

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