Clinical Trial: Establishing Visualization Grading Scale on LESS Cholecystectomy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Grading System for Laparoscopic Visualization and Predicting Factors That Affect Visualization Level During Laparoscopic Cholecystectomies: A Prospective, Single Group, Open Label Study
Brief Summary: Essential to laparoscopic operations is adequate visualization. Unfortunately there is no grading system to assess the degree or quality of visualization. The primary objective of the project is to develop a laparoscopic visualization scoring system. We also intend to investigate the effects of neuromuscular blockade agents on visualization.
Detailed Summary:
Essential to laparoscopic operations is adequate visualization. Unfortunately there is no grading system to assess the degree or quality of visualization. There are many contributing factors that either assist or hinder the quality. Compared to open surgical procedures, laparoscopic surgical procedures (Laparo-endoscopic Single Site (LESS) and conventional multiport) are associated with less postoperative pain, a lower wound infection rate, shorter length of hospital stays and reduced incidence of late ventral hernia(1). Despite these well documented benefits of laparoscopic procedures, laparoscopy in certain patient populations can be challenging. Preoperative factors that contribute to technical difficulty in performance of laparoscopic procedures include male gender, android body habitus, and body mass index (BMI) greater than 30 kg/m2(2). Men often have an android body habitus, whereby the excess body fat concentrates within the peritoneal cavity, increases intra-abdominal pressure and thus reduces intraoperative laparoscopic visualization. Intra-abdominal pressure measured in morbidly obese patients is 2-3 times higher than in non-obese patients. In addition, android body habitus and high BMI are often associated with an enlarged left lobe of the liver. These factors can contribute to the degree of intraoperative technical difficulty and should be weighed in selection of appropriate patients to undergo laparoscopic procedures.
Particularly in the early period of the surgeon's learning curve, we suggest that selection criteria for laparoscopic procedures for the upper abdomen be limited to patients with a low BMI and no previous upper abdominal surgery. Although low BMI is a relatively good predictor of a less challenging laparoscopic procedure, a high BMI does not necessarily predict intraoperative technical difficulty. We predict that the best method to determine th
Sponsor: Florida Hospital Tampa Bay Division
Current Primary Outcome: Laparoscopic Visualization Score assessment [ Time Frame: Start to end of LESS Cholecystectomy ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- pneumoperitoneum volume [ Time Frame: start to end of LESS cholecystectomy ]
- factors influencing visualization [ Time Frame: start to end of LESS cholecystectomy ]
- Degrees of visualization [ Time Frame: start to end of LESS cholecystectomy ]
- surgical incision to sterile wound dressing
- sterile wound dressing to extubation
- sterile wound dressing to patient exiting operating room
- postoperative pain [ Time Frame: every day until 7 days after LESS cholecystectomy ]
Original Secondary Outcome: Same as current
Information By: Florida Hospital Tampa Bay Division
Dates:
Date Received: October 1, 2014
Date Started: September 2013
Date Completion:
Last Updated: August 18, 2016
Last Verified: August 2016
