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Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy

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National Taiwan University

Status

Unknown

Conditions

Adrenal Tumors

Treatments

Procedure: needlescopic adrenalectomy and laparoscopic adrenalectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00713115
200803040R

Details and patient eligibility

About

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 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.

Enrollment

60 estimated patients

Sex

All

Ages

3 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of Benign Adrenal Tumors

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Chun-Hou Liao, MD

Data sourced from clinicaltrials.gov

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