Brief Title
Establishing Visualization Grading Scale on LESS Cholecystectomy
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 Description
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 the
technical difficulty of laparoscopic procedures is during intraoperative evaluation. For
example, the primary limiting factor in determining the technical difficulty of laparoscopic
Roux-en-Y gastric bypass (RYGBP) is the size and thickness of the left lobe of the liver. A
massively enlarged left lobe of the liver obscures the laparoscopic view of the
gastro-esophageal junction and angle of His, making the gastrojejunal anastomosis difficult
to construct. Schwartz et al. support this concept when they found that a large liver was the
primary reason for conversion from laparoscopic to open RYGBP in an analysis of 1,000
patients (2).
A laparoscopic operation consists of making small punctures into the peritoneum, through
which, a camera and surgical instruments are subsequently inserted. The laparoscopically
placed camera is the only view of the operative field. Since this point of view is constantly
changing to meet the surgeon's needs during the operation, and because it is very different
from the exoscopic view of the surgeon, the surgeon has to be very well trained to interpret
the images through the laparoscopic view. For LESS operations, a deflectable tip laparoscope
is utilized in aiding the surgeon for improved visibility and less clashing of instruments.
The laparoscopic view does not reveal, at one time, all the structures the surgeon needs to
see in order to complete the surgical procedure with success. These structures can, for
instance, be hidden behind the peritoneal wall (e.g., the ureter). This limitation cannot
only lead to a less efficient operation, but can also lead to complications. Often such
structures can be extracted from preoperative CT/MR images; however, the surgeon needs to
interpret and fuse these images with the laparoscopic view. To alleviate this problem, we
propose a laparoscopic visualization scoring system based on the intraoperative quality of
images (3).
The impact of muscle relaxants on the isolated abdominal wall or diaphragmatic behavior and
the absolute intra-abdominal volume are difficult to measure. Conversely, the inflated
volume-pressure relationship of the abdominal cavity is easier to measure. A description of
this volume-pressure relationship has not been identified in previous studies. Clinical data
supports a positive linear correlation between the depth of neuromuscular blockade and
abdominal wall and diaphragmatic relaxation and compliance (4). There is a very tangible and
real effect of the neuromuscular blockade; this ultimately has a direct impact on the quality
of visualization of the surgical field during a laparoscopic procedure (5). A constant
neuromuscular block leads to preferable working conditions for the surgeon. The evoked muscle
responses after neurostimulation can be registered by electromyography (EMG),
mechanomyography (MMG) and acceleromyography (AMG). In principle, different peripheral nerves
can be used for neurostimulation. The EMG records the electrical signal generated by the
muscular action potential under its surface electrodes. The force of the thumb after
stimulation can be registered by MMG. The AMG records the acceleration of the thumb after
neurostimulation. The EMG, MMG and AMG system allows for observation of the measured signals
quantity and quality (6).
We have identified other relevant factors that significantly affect the quality of
visualization during different laparoscopic procedures including:
1. Clarity, focus and brightness:
The laparoscope typically consists of an outer ring of optical fibers used to transmit
light into the body, and an inner core of rod lenses that illuminate visual scene. This
is then relayed back to the camera. Various different types of laparoscopes are
available; they are specified in terms of overall length, number of rods, diameter and
angle of view. Generally speaking, the wider the scope the brighter the resulting image.
Lenses are available in the range of 1.9mm to 12mm, but sizes of 5mm and 10mm are the
most common choices for pediatric and adult patients, respectively.
2. Breadth of intra-abdominal field and vertical space measured in centimeters:
Breadth of intra-abdominal field and vertical space are factors directly related to
pressure insufflation as well as the level of the neuromuscular blockade.
3. Distracting factors:
This specific category of distracting factors includes:
1. Blood: the presence, especially in large quantities, may prevent adequate
visualization.
2. Smoke: unipolar electrocautery and/or the bipolar Maryland forceps produce smoke
when used. The rate of aspiration and evacuation also affect visualization.
3. Adhesions: the presence of intra-abdominal adhesions, which hinders and prohibits
proper identification of the anatomic structures.
4. Sterile iodine impregnated covering sheet: its application presumably has a
negative impact on abdominal wall and diaphragmatic compliance, and therefore, may
obscure visualization.
5. Intra-intestinal air: the presence of air inside the stomach, and small and large
intestines adversely affects the size of the visual field. This can be prevented by
an adequate preoperative bowel preparation and placement of an aspiration NG tube
during anesthesia induction.
4. Patient's specific factors such as BMI value and body habitus:
From our experience, a BMI under 26 allows for optimal field visualization. Conversely,
a BMI greater than 26 negatively impacts the visual field. However, a recent study
conducted by Camani et al. in 2010 showed that the laparoscopic approach in the various
applications of gynecologic surgery is not significantly influenced by BMI in terms of
surgical outcomes, laparotomy conversion rate, intraoperative and postoperative
complication rate, and duration of hospital stay (4). We feel that visualization during
operations involving the abdominal cavity are adversely affected by high amounts of
adipose tissue, and therefore, a visualization scoring system will help support this
theory.
5. Type of disorder (malignant vs. benign) that the laparoscopic procedure is undertaken
for:
Due to many pathologic factors such as the need for R0 resections, the discovery of more
advanced disease than anticipated, the presence of adhesions or scar tissue from
previous operations, laparoscopic procedures for malignant disorders may require a
better visualization field than laparoscopic procedures undertaken for benign disorders.
6. Inadequate and/or poorly designed instruments:
Most laparoscopic instrument development is technology-driven. This approach to
instrument design does not always consider the ergonomics of the users, therefore
leading to a user-unfriendly product (4, 5).
7. Technical difficulties:
An intraoperative technical difficulty is defined as a significant deviation from the
ordinary surgical procedure. All conversions to an open operation and iatrogenic bowel
perforation during laparoscopic surgery are examples of technical difficulties. Many
studies demonstrate that a technical difficulty during laparoscopic-assisted surgery
jeopardizes both the intra-operative and postoperative patient safety.
8. Patient's body position during laparoscopic procedure:
A study led by Mulier, J et al. in 2010 demonstrated that the Trendelenburg position for
lower abdominal surgery and reverse Trendelenburg with flexing of the legs at the hips for
upper abdominal surgery effectively improved the workspace in obese patients, even with full
muscle relaxation (6).
II. Objectives A.Primary Objective The primary objective is to develop a laparoscopic
visualization scoring system.
B. Secondary Objectives
The secondary objectives are:
1. To determine how visualization is affected by various levels of pneumoperitoneum
correlated with neuromuscular blockade.
2. Identify the factors that influence visualization, and determine how to manage these
factors to optimize visualization.
3. Determine if there is a statistically significant correlation between different degrees
of visualization and the following intraoperative time intervals:
1. surgical incision to sterile wound dressing
2. sterile wound dressing to extubation
3. sterile wound dressing to patient exiting operating room
4. Determine if there is a statistically significant correlation between different degrees
of visualization and postoperative pain.
Study Type
Interventional
Primary Outcome
Laparoscopic Visualization Score assessment
Secondary Outcome
pneumoperitoneum volume
Condition
Cholecystitis
Intervention
Cholecystectomy visualization
Study Arms / Comparison Groups
Cholecystectomy visualization
Description: All patients will undergo a standard single site cholecystectomy and will have their operation recorded and scored for visualization.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
30
Start Date
September 2013
Completion Date
August 2016
Primary Completion Date
June 2016
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Alexander S. Rosemurgy, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02264444
Organization ID
461326
Responsible Party
Principal Investigator
Study Sponsor
Florida Hospital Tampa Bay Division
Collaborators
Merck Sharp & Dohme LLC
Study Sponsor
Alexander S. Rosemurgy, MD, Principal Investigator, Florida Hospital Tampa Bay Division
Verification Date
July 2017