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Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy (PRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01676025
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Kyu Eun Lee, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE August 22, 2012
First Posted Date  ICMJE August 30, 2012
Last Update Posted Date October 6, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date February 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
Operation time [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ]
operation time will be measured by attending nerse
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
  • Pain sensation after surgery [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ]
    Pain score will be described daily during hospitalization, and also at out patient clinic after discharge
  • Recovery of bowel movement [ Time Frame: Participants will be followed the duration of hospital stay, an expected average of 5 days ]
    Gas out is regarded as a recovery of bowel movement
  • Wound complication [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ]
  • Blood loss during operation [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ]
  • Intra-operative hemodynamic status [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ]
    Events as below will be recorded and compared severe hypertension(systolic BP>200mmHg), severe hypotension(systolic BP<90mmHg), Tachycardia(HR>110/min), Bradycardia(HR<50/min)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy
Official Title  ICMJE Randomized Controlled Trial Between PRA(Posterior Retroperitoneoscopic Adrenalectomy) and LA(Laparoscopic Adrenalectomy)
Brief Summary The purpose of this study is to compare two surgical methods of adrenalectomy. One is called PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through patient's abdominal cavity after making 3 or 4 holes in the abdomen.
Detailed Description

Since 1992, transabdominal LA(laparoscopic adrenalectomy) has been a standard method of adrenalectomy. This traditional method has been used widely because this procedure provides wide view of the whole abdomen which is familiar to surgeons. But due to its unique location at retroperitoneum, adrenal is still not easy to approach. So various retroperitoneal approaches were designed and adjusted. Among those, PRA(posterior retroperitoneal adrenalectomy) has showed good outcomes in many institutes. PRA facilitates direct approach to kidney and adrenal gland, and so operative time can be shortened. But there has been no randomized controlled trial between these two methods.

Therefore, as experienced surgeons in both methods, we want to practice this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adrenal Disease
Intervention  ICMJE
  • Procedure: PRA
  • Procedure: LA
Study Arms  ICMJE
  • Experimental: PRA
    Persons who get PRA surgery.
    Intervention: Procedure: PRA
  • Experimental: LA
    Persons who get LA surgery.
    Intervention: Procedure: LA
Publications * Chai YJ, Yu HW, Song RY, Kim SJ, Choi JY, Lee KE. Lateral Transperitoneal Adrenalectomy Versus Posterior Retroperitoneoscopic Adrenalectomy for Benign Adrenal Gland Disease: Randomized Controlled Trial at a Single Tertiary Medical Center. Ann Surg. 2019 May;269(5):842-848. doi: 10.1097/SLA.0000000000002603.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2017)
83
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2012)
84
Actual Study Completion Date  ICMJE February 28, 2016
Actual Primary Completion Date February 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who are expected to have benign adrenal disease at preoperative exams
  • Patients who have pheochromocytoma measured less than 5cm, and the other benign adrenal tumors less than 7cm in diameter in preoperative CT scan
  • Patients who do not have previous surgery history at the interested quadrant
  • Patients who is I or II grade in ASA classification(American society of anesthesiologists' physical status classification)
  • Patients who has tolerable liver function and renal function(bilirubin<2.0mg/dl and AST, ALT, serum creatinine within twice of upper normal range, coagulation panel : within normal limit)
  • Patients whose BMI(body mass index) is less than 35
  • Patients who are supposed to have normal cognitive function
  • Patients who signed the consent paper.

Exclusion Criteria:

  • Patients who are expected to have malignant or metastatic adrenal tumor at preoperative exams
  • Patients who have bilateral adrenal tumors
  • Patients who have condition to undergo the other operation at the abdomen together with adrenalectomy
  • Pregnant patients
  • Patients who have active or uncontrolled infection
  • Patients who have medical problems as below
  • Uncontrollable hypertension with medication(Systolic BP>150 or diastolic BP>100)
  • Angina, congestive heart failure, acute myocardial infection
  • History of coronary angioplasty or Coronary artery bypass graft surgery
  • History of stroke, transient ischemic attack with sequela
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01676025
Other Study ID Numbers  ICMJE Kyu.eun.lee-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyu Eun Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyueun Lee, Ph.D Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP