Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00713115
Other study ID # 200803040R
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT00669266 - Adrenal Tumors - Pathogenesis and Therapy
Completed NCT00997594 - Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation Phase 2/Phase 3
Recruiting NCT00894335 - Anesthesia Management of Retroperitoneal Adrenalectomies N/A
Completed NCT00591643 - Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) Phase 1
Completed NCT01284829 - Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study N/A
Recruiting NCT06100367 - 11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours Phase 2/Phase 3