Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE
Launched by SAN GIOVANNI ADDOLORATA HOSPITAL · Apr 19, 2011
Trial Information
Current as of April 29, 2025
Unknown status
Keywords
ClinConnect Summary
The aim of this study is to assess possible differences between the LESS approach and the standard laparoscopic approach to cholecystectomy. In particular, the Postoperative Quality of Life (QoL) will be investigated by analyzing the followings: length of hospital stay (LoS), postoperative pain, cosmetics and the results of SF 36 questionnaire. Furthermore, operative time, conversion to standard LC rate, difficulty of exposure, difficulty of dissection, and complication rate will be compared.
Altman nomograms were used to calculate the presumed sample size of an actual RCT, arbitrarily ass...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • age 18-75
- • BMI \< 35
- • no previous upper GI or right colonic surgery with severe adhesions gallstones with absence of clinical signs of acute cholecystitis, bile duct stones or pancreatitis.
- • ASA I-III
- • Nassar grade of difficulty in performing a laparoscopic cholecystectomy I-III
- • diagnosis: cholelithiasis
- Exclusion Criteria:
- • cholecystitis
- • existence of common duct stones
- • presence of biliary cancer
- • Previous abdominal surgery on organs of the supramesocolic space
About San Giovanni Addolorata Hospital
San Giovanni Addolorata Hospital is a prestigious healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Located in Rome, Italy, the hospital is renowned for its commitment to excellence in clinical practice and research, fostering collaboration among multidisciplinary teams of healthcare professionals. With a focus on patient safety and ethical standards, San Giovanni Addolorata Hospital aims to contribute significantly to the development of new therapies and treatments, enhancing the quality of life for patients across various medical fields.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, Lazio, Italy
Patients applied
Trial Officials
Marco Maria Lirici, FACS
Principal Investigator
San Giovanni Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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