Learning Curve for Laparoscopic Distal Pancreatectomy

This study has been completed.
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01258621
First received: December 10, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

December 10, 2010
December 10, 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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Operative Time [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ] [ Designated as safety issue: No ]
  • Blood loss [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ] [ Designated as safety issue: No ]
  • Length of Hospital Stay [ Time Frame: Postoperative. From 0 to 30 days after discharge. ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01258621
PANCREAS-LDP2010
No
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