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Learning Curve for Laparoscopic Distal Pancreatectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01258621
First Posted: December 13, 2010
Last Update Posted: December 13, 2010
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.
Information provided by:
Università Vita-Salute San Raffaele
December 10, 2010
December 13, 2010
December 13, 2010
March 2009
August 2010   (Final data collection date for primary outcome measure)
Conversion to open surgery [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ]
Same as current
No Changes Posted
  • Operative Time [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ]
  • Blood loss [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ]
  • Length of Hospital Stay [ Time Frame: Postoperative. From 0 to 30 days after discharge. ]
Same as current
Not Provided
Not Provided
 
Learning Curve for Laparoscopic Distal Pancreatectomy
Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital
Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has recently becoming the treatment of choice in experienced centres. No data have been published about learning curve so far. The purpose of this study was to identify the learning curve period for performing LDP.
Between March 2009 and August 2010 all patients with lesion of body or tail of pancreas were assessed for eligibility for LDP. Exclusion criteria were: major vessels contact in cancer patients, severe organ dysfunction, BMI > 35, and refusing laparoscopic approach. All laparoscopic procedures were carried out by the same surgical team with large experience in open pancreatic surgery. All patients were treated according to an early recovery after surgery protocol. Primary endpoint was conversion rate. Secondary endpoints were operation time, operative blood loss, postoperative morbidity, and length of stay.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Lesions Located at Body or Tail.
Procedure: Laparoscopy
Laparoscopic distal pancreatectomy
Experimental: Laparoscopic Distal Pancreatectomy
Intervention: Procedure: Laparoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • pancreatic lesion located at body or tail

Exclusion Criteria:

  • major vessels infiltration
  • severe organ dysfunction
  • refusing laparoscopic approach
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01258621
PANCREAS-LDP2010
No
Not Provided
Not Provided
Marco Braga, MD, Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
Not Provided
Not Provided
Università Vita-Salute San Raffaele
August 2010

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