Cholecystitis Clinical Trial
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
Verified date | July 2017 |
Source | Florida Hospital Tampa Bay Division |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Signed informed consent - 18 years of age and older - All patients deemed to have a clinical and surgical indication to undergo a LESS cholecystectomy Exclusion Criteria: 1. Pregnancy 2. Breastfeeding 3. BMI>35 4. Serious comorbidities precluding a LESS cholecystectomy 5. Known or suspected neuromuscular disorders impairing neuromuscular function 6. Allergies to muscle relaxants, anesthetics or narcotics utilized for this study 7. A (family) history of malignant hyperthermia 8. A contraindication for neostigmine administration 9. Chronic opioid use 10. Prolonged QT syndrome 11. Creatinine >2.0 |
Country | Name | City | State |
---|---|---|---|
United States | FloridaHTBD | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida Hospital Tampa Bay Division | Merck Sharp & Dohme Corp. |
United States,
Camanni M, Bonino L, Delpiano EM, Migliaretti G, Berchialla P, Deltetto F. Laparoscopy and body mass index: feasibility and outcome in obese patients treated for gynecologic diseases. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):576-82. doi: 10.1016/j.jmig.2010.04.002. Epub 2010 Jul 8. — View Citation
McDougall EM, Figenshau RS, Clayman RV, Monk TG, Smith DS. Laparoscopic pneumoperitoneum: impact of body habitus. J Laparoendosc Surg. 1994 Dec;4(6):385-91. — View Citation
Mulier JP, Dillemans B, Van Cauwenberge S. Impact of the patient's body position on the intraabdominal workspace during laparoscopic surgery. Surg Endosc. 2010 Jun;24(6):1398-402. doi: 10.1007/s00464-009-0785-8. Epub 2010 Jan 7. — View Citation
Nguyen NT, Longoria M, Gelfand DV, Sabio A, Wilson SE. Staged laparoscopic Roux-en-Y: a novel two-stage bariatric operation as an alternative in the super-obese with massively enlarged liver. Obes Surg. 2005 Aug;15(7):1077-81. — View Citation
Schrenk P, Woisetschläger R, Rieger R, Wayand WU. A diagnostic score to predict the difficulty of a laparoscopic cholecystectomy from preoperative variables. Surg Endosc. 1998 Feb;12(2):148-50. — View Citation
Simanski , R. Kahler, B. Pohl, R. Hofmockel, R. Friedrich, B. P. Lampe Measurement and control of neuromuscular blockade and depth of anaesthesia. Proceedings of the European Control Conference, Cambridge/UK. 2003.
Stijn de Buck, Johan van Cleynenbreugel, Indra Geys, Thomas Koninckx, Philippe R Koninck, Paul Suetens. A System to Support Laparoscopic Surgery by Augmented Reality Visualization. Medical Image Computing and Computer-Assisted Intervention; 691-8, 2001.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Laparoscopic Visualization Score assessment | Start to end of LESS Cholecystectomy | ||
Secondary | pneumoperitoneum volume | start to end of LESS cholecystectomy | ||
Secondary | factors influencing visualization | start to end of LESS cholecystectomy | ||
Secondary | Degrees of visualization | surgical incision to sterile wound dressing sterile wound dressing to extubation sterile wound dressing to patient exiting operating room |
start to end of LESS cholecystectomy | |
Secondary | postoperative pain | every day until 7 days after LESS cholecystectomy |
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