San Raffaele Hospital
Milan, 20132, Italy
Completed
NCT Number: NCT01258621
Learning Curve for Laparoscopic Distal Pancreatectomy
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.
Completed
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- pancreatic lesion located at body or tail
Exclusion criteria
- major vessels infiltration
- severe organ dysfunction
- refusing laparoscopic approach
Treatment and study plan
Laparoscopy
ProcedureLaparoscopic distal pancreatectomy
Primary outcomes
-
Conversion to open surgery
Time frame: during surgery; 3 to 5 hours from the start of the procedure
Secondary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Università Vita-Salute San Raffaele
Other
Registry information
Official study title
Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital
Important dates
- Study start
- 2009
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Dec 13, 2010
- Registry last updated
- Dec 13, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.