Clinical trial NCT00713115: Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy
Official title: Prospective Randonmized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Benign Adrenal Tumors Less Than 5 cm in Diameter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adrenal Tumors
Keywords: laparoscopy, needlescopy, adrenalectomy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Benign Adrenal Tumors

Exclusion Criteria:

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

Primary outcomes:
measure: Operative time, blood loss, intraoperative and postoperative complication, pain score, convalescence, cosmesis
timeFrame: 1 month
Secondary outcomes:
measure: cost
timeFrame: 1 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shih-Chieh Chueh, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.