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Search / Trial NCT01339325

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

Laparo Endoscopic Single Site Cholecystectomy Quality Of Life Postoperative Pain Cosmetics Complication

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.

Locations

Rome, Lazio, Italy

Patients applied

0 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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