NCT02264444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

2.8 years

First QC Date

October 1, 2014

Last Update Submit

July 26, 2017

Conditions

Cholecystitis

Keywords

Cholecystectomy, visualization, single incision

Outcome Measures

Primary Outcomes (1)

  • Laparoscopic Visualization Score assessment

    Start to end of LESS Cholecystectomy

Secondary Outcomes (4)

  • pneumoperitoneum volume

    start to end of LESS cholecystectomy

  • factors influencing visualization

    start to end of LESS cholecystectomy

  • Degrees of visualization

    start to end of LESS cholecystectomy

  • postoperative pain

    every day until 7 days after LESS cholecystectomy

Study Arms (1)

Cholecystectomy visualization

EXPERIMENTAL

All patients will undergo a standard single site cholecystectomy and will have their operation recorded and scored for visualization.

Other: Cholecystectomy visualization

Interventions

Cholecystectomy visualizationOTHER

Patients undergo a standard removal of the gallbladder through a single incision at the umbilicus will have their operation recorded and graded according to a scale that is established for this study.

Cholecystectomy visualization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • years of age and older
  • All patients deemed to have a clinical and surgical indication to undergo a LESS cholecystectomy

You may not qualify if:

  • Pregnancy
  • Breastfeeding
  • BMI\>35
  • Serious comorbidities precluding a LESS cholecystectomy
  • Known or suspected neuromuscular disorders impairing neuromuscular function
  • Allergies to muscle relaxants, anesthetics or narcotics utilized for this study
  • A (family) history of malignant hyperthermia
  • A contraindication for neostigmine administration
  • Chronic opioid use
  • Prolonged QT syndrome
  • Creatinine \>2.0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FloridaHTBD

Tampa, Florida, 33613, United States

Location

Related Publications (7)

  • Schrenk P, Woisetschlager 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. doi: 10.1007/s004649900616.

    PMID: 9479730BACKGROUND

  • 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. doi: 10.1381/0960892054621062.

    PMID: 16105411BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20619751BACKGROUND

  • 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. doi: 10.1089/lps.1994.4.385.

    PMID: 7881141BACKGROUND

  • 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.

    PMID: 20054583BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Alexander S. Rosemurgy, MD

    Florida Hospital Tampa Bay Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director HPB Surgery, GERD Center

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 15, 2014

Study Start

September 1, 2013

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)