Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04661319 |
| Other study ID # |
Seoul-10 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
December 2020 |
| Source |
Seoul St. Mary's Hospital |
| Contact |
Tae ho Hong, MD. PhD |
| Phone |
+82-10-5206-5266 |
| Email |
gshth[@]catholic.ac.kr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Surgical practice training often suffers from poor educational efficiency due to the
technical difficulties of the cases, the lack of resources and the cases in the operating
room. The video editing training method is not included in the standard surgical training,
but it has the advantage of reducing trial and error and errors during surgery, simplifying
training time, and cost-effective. Investigators analyzed whether the video editing teaching
method has effective value for trainees compared to the traditional teaching method.
The primary purpose of the study is the trainee's learning achievement in terms of surgical
skills. Learning achievement is measured as the difference in pre- and post-educational test
scores (The Global Operative Assessment of Laparoscopic Skills (GOALS)) to compare the
difference in achievement.
The secondary objective of the study was to evaluate the satisfaction with the video editing
method as an educational method by conducting a questionnaire survey to all the trainees
participating in the study. In addition, the degree of postoperative pain, postoperative
hospitalization period, postoperative readmission and the need for additional procedures were
compared and analyzed.
Description:
1. background Traditional education teaches surgery in a one-on-one apprenticeship of
surgeons and practitioners, in which the surgeon learns to perform surgical operations
under the supervision of a qualified surgeon. The supervisor surgeon instructs the
trainee and, if necessary, temporarily takes over the procedure to show the difficult
steps. Today, a proven educational platform has been established to prevent the risk of
patients being exposed to the early learning curve, allowing trainees to sufficiently
hone their basic skills in open and laparoscopic surgery.
Laparoscopic surgery requires complex techniques and techniques that are not used in
open surgery. Laparoscopic instruments provide limited haptic feedback, lack of freedom,
and video monitors that provide a two-dimensional projection of the operating room
impair depth perception, making surgery more difficult. Therefore, surgeons must master
these technical challenges before performing laparoscopic procedures properly and
safely.
Animal model training and cadaver training are very useful, but have the disadvantages
of being small in number and expensive to use. On the other hand, books, the Internet,
and educational videos have the advantage of being able to provide important basic
knowledge about disease and surgical treatment, but the most important factor in
training specific surgical procedures is from the trainee side to the real patient
together with an experienced surgeon Since it is a practical training for Korea, the
teaching method still used is the apprenticeship method. The main drawback of this
traditional approach is that the trainee or supervising surgeon can only perform the
step once per operation. When the supervisor takes over, the memories of training with
the trainee who have to wait for the next task to be performed are lost.
Therefore, investigators devised a new training method called surgical video editing in
order to minimize the frequency of supervisor intervention and maximize the actual
surgical practice time of the trainee. This method is used by the trainee himself to
review the surgical process, Since the essential skills can be recalled and learned, it
can have the effect that the trainee can easily learn the surgery during the actual
surgery.
2. Target disease : Patients with uncomplicated symptomatic gallstone disease who are
scheduled operation
3. Selection criteria, exclusion criteria, target number of subjects
1. inclusion criteria
1. trainees in general surgery
2. No experience of laparoscopic cholecystectomy
3. Less than 5 experiences of laparoscopic surgery
4. Uncomplicated symptomatic gallstone disease
2. Exclusion Criteria
1. Experience with laparoscopic cholecystectomy.
2. More than 5 experiences of laparoscopic surgery
3. Target number and evidence In the existing literature, it was assumed that the
difference between the video editing group and the control group in the primary
result was 20% or more. This difference was assumed to be a 2-sided confidence
level of 95% with a power of two-sided significance level α = 0.2 and power 80%,
and 45 subjects were assigned to each group considering the dropout rate of 10%.
4. Random allocation schedule and operation Randomization was assigned using block
randomization without stratification, and in order to maintain unpredictability,
which is the basic principle of randomization, the randomization table will be
completed by applying a block size of 2 or 4 or 6. .
The allocation envelope in which the randomization number and allocation group are
recorded is made of opaque material so that it can be blinded, and it is kept sealed
until randomization is performed for each subject.
The person in charge of the clinical trial or the person in charge of the clinical trial
finally confirms the criteria for exclusion, and if the subject is suitable, assigns a
random assignment number and keeps it in the assignment bag. Afterwards, the study nurse
unseals the assignment bag with the assignment number and conducts D education in the
administration group assigned to the subject according to each random assignment number.
The research nurse must record the release information (release date and release person)
immediately upon release of the sealing of the assignment envelope, and the random
assignment envelope that has already been released can be re-assigned to another subject
even if the subject has withdrawn consent will not be.
4. Clinical test method (administration/dosage, administration/use method,
administration/use period, combination therapy, etc.) A. study design : Prospective
multicenter randomized controlled trial B. Describe the treatment for the experimental
group / control group
1. Clinical trial flow
1. The subject's preoperative residency year, instrument experience, open surgery
experience, laparoscopic surgery experience, and preoperative instrument
proficiency are evaluated.
2. Basic anatomical and scientific education for laparoscopic cholecystectomy,
practice laparoscopic instruments for at least 30 minutes every other week,
and observe 3 cases of laparoscopic cholecystectomy.
3. Select a random experimental group.
4. For each selected group, 3 cases of surgical observation or 3 cases of video
editing are performed.
- The person in charge of the clinical trial or the person in charge of the
clinical trial finally confirms the criteria for exclusion from
selection, and if the subject is suitable, assigns a random assignment
number and keeps it in the assignment bag. After that, the research nurse
receives the assignment bag with the assignment number and unseals the
assignment bag to proceed with the training method according to the
assigned group assigned to the subject according to each random
assignment number.
5. Both groups operated on 10 cases, and both groups were discharged from the
hospital after undergoing the same recovery procedure after the same
operation.
6. Patients undergo a hematological test, blood chemistry test, urine test,
coagulation test, and chest x-ray on the first day after surgery. (Examination
and treatment are performed according to the Clinical Pathway of the current
gallbladder surgery-clinical practice guidelines-)
7. If there are no specifics, patients should start with a liquid meal in the
morning of the first day after surgery.
8. Patients are discharged from the hospital on the 2nd day after surgery if
there are no specifics.
9. Follow-up of complications during hospitalization and after discharge of
patients.
2. Surgery method
1. Start the operation under general anesthesia.
2. Install a trocar of 10mm on the navel, 5mm below the knuckle, and 5mm on the
right upper abdomen.
3. Relief surgery is performed using CO2 gas in the abdominal cavity. -The back
pressure through CO2 gas is maintained at 12mmHg/and 2L/min.
4. Start dissection from Calot's triangle and proceed with the surgery using the
retrograde cholecystectomy method. -The gallbladder duct is ligated with a
10mm clip and the gallbladder artery is also ligated with a 10mm clip. -If the
gallbladder duct is ligated unstable, perform ligation through an endoloop.
-After ligation, the gallbladder is detached from the liver.
5. Wash the surgical site.
6. Put the exfoliated gallbladder in a laparoscopic pocket and discharge it
through the navel.
7. Remove the trocar, suture the skin, and finish the operation.
3. Discharge principle
1. When hematologically stable and vital signs are stable
2. When the patient's condition is stable by proceeding to a normal liquid diet
5. Observation variables/clinical test item and observation test method A. Observation item
1. Pre-test investigation Before entering the clinical trial, the following matters
are checked through interviews, chart checks, and questions about the subject's
background (demographic information), and recorded in the case record.
1. Background check: Subject's initials, date of birth, gender, residency year,
instrument experience, open surgery experience, laparoscopic surgery
experience, preoperative instrument skill evaluation
2. Patients undergoing surgery: history, sex, age, diagnosis,
2. Examination of surgical technique before operation
① Laparoscopic cholecystectomy The surgical image is viewed, and the anatomical
structure and surgical process in the image, and the necessary technical areas
(correct placement of trocar, carrot triangle structure, related anatomy, clip
placement and resection structure) are evaluated and scored.
- Basic Laparoscopic Skills Assessment: The Global Operative Assessment of
Laparoscopic Skills (GOALS)
3. Examination of surgical technique
- The Global Operative Assessment of Laparoscopic Skills (GOALS) and technical
rating scale (TRS) by viewing images of two groups of laparoscopic
cholecystectomy
- In case of intervention of supervisor during surgery: 0.5 point deduction
for verbal intervention and 1 point deduction for behavioral
intervention.
4. Subject evaluation
- Evaluating the anatomical structure during surgery and how difficult the
surgical procedure was: a score of 10
- Confidence in overall operation progress: evaluated with a score of 10 ③
Value of surgical observation and video editing on the progress of the
surgery: evaluated as a score of 10
5. Patients who underwent surgery
- Hospital stay period after surgery, hematological test the day after surgery,
blood chemistry test, urine test, blood coagulation test
- Surgical site infection
- Check at each patient visit. If there is redness, hot sensation, or
abscess at the site of trocar insertion, it is defined as a superficial
surgical site infection.
- If there is fluid retention and abscess around the surgical site in the
abdominal cavity, it is defined as a deep surgical site infection.
- Distant infection : : Respiratory and urinary system infections and
bacteremia or lymphatic inflammation ③ Check for bile leakage.
- Groups with drainage pipes are identified through the drainage
pattern. In the group without drainage tube, selective radiological
follow-up (CT, sonogram, MRCP) was performed in cases of epigastric
pain, indigestion, fever, and jaundice after surgery.
6. Surgery time, blood loss description.
7. Describe post-operative complications (other than those described above).
6. Predicted side effects and precautions for use : none
7. Criteria for stopping/dropping of the study When the following occurs, the test should
be stopped, and the reason and findings of the interruption should be recorded in the
case record.
1. In the case that a patient's life-threatening side effect is expressed after surgery,
and the investigator determines that it is necessary to stop
2. In case the subject refuses or withdraws consent after the start of the test
3. If it is determined that it is inappropriate as a target patient after starting the test
4. In the case of receiving training that can affect the improvement of surgical skills,
such as other cadeveric practice, without the permission of the test manager after the
start of the test
5. When it is judged that it is impossible to conduct an inspection or investigation after
the start of the test due to the circumstances of the subject
6. In case the test manager determines that it is necessary to stop the test after the
initiation of the test because it is life-threatening or the effect is manifested during
surgery.
8. Effect evaluation criteria, evaluation method and interpretation method (statistical
analysis method)
1. Analysis of efficacy variables
- Analysis of primary efficacy variables.
: Measured by the difference between the trainee's pre- and post-educational test scores
(The Global Operative Assessment of Laparoscopic Skills, GOALS), and tested using the
student's t-test or wilcoxn's rank sum test according to the satisfaction of the normal
distribution assumption, Descriptive statistics (mean, standard deviation, median,
minimum, maximum) are presented. In addition, the difference between the two groups'
test scores (test group-control group) is presented as the mean and 95% confidence
interval, and it can be confirmed that there was a learning effect when the difference
in test score improvement between the two groups was 20% or more.
2. Analysis of secondary efficacy variables For categorical variables for hospital stay,
operation time, and complication data obtained as secondary endpoints, n (%) is
presented, and the difference in ratio between the two groups is tested using Chi-square
or Fisher's exact test. In the case of continuous variables, the mean, standard
deviation, median, minimum, and maximum values are presented, and normality tests are
performed to test with Student's t-test for normal distribution, and Wilcoxon rank-sum
test for nonnormal distribution. The investigators will test the difference between the
two groups. For all statistical analysis, SPSS version 21.0 will be used, and those
below the significance level of 0.05 will be judged as statistically significant.
3. Analysis target group
1. intention to treat analysis group Randomization is performed only when the
selection criteria described above are met, and all randomized subjects are to be
included in the statistical analysis.
2. per protocol analysis group The per protocol analysis group is defined as a trainee
whose training has ended after receiving random assignments and assessed test
scores.
4. How to deal with missing values This study is a prospective study, and it is expected
that there will be no missing values of the primary or secondary endpoints during the
experiment period. However, if missing values occur, the missing values should be
substituted with the average value.
5. How to handle compliance Since the intervention applied in this study is an intervention
performed during surgery while the patient is under general anesthesia, there will be no
difference in treatment compliance. In addition, postoperative chest radiography and
pain assessment have been previously included in the clinical pathway of laparoscopic
cholecystectomy, so there is no difference in treatment compliance.
9. Safety evaluation criteria including side effects, evaluation methods and reporting
methods In the event of adverse reactions and side effects after surgery, subjects are
educated to report to the researcher, and the occurrence of adverse reactions is checked
and recorded at each visit, and symptoms, time of appearance, duration, degree of
adverse reactions, and causal relationship with test drugs Are recorded in the case
record. In the event of serious adverse reactions or unexpected problems, the lead
researcher should report to the IRB.
10. Rules for compensation for victims Laparoscopic cholecystectomy is a safe operation
with extremely low risk of surgery. Also, there are basically no additional risks that
accompany the study. Since antibiotics are drugs that have been used previously, there
is no additional occurrence other than known complications. If participants get an
injury or illness by participating in this study, medical treatment will be provided.
The investigators will provide participants with a quick diagnosis and treatment if
necessary through a referral for consultation with a medical professional related to the
relevant clinical symptoms or signs.
11. preparation for the safety protection of subjects 19.1 Clinical trial agency The
head of the conducting institution shall make every effort to protect the safety of the
subjects by equipping them with the necessary facilities and specialized personnel for
conducting the relevant clinical trial step by step so that the clinical trial can
proceed properly as specified in this study protocol. The person in charge of the
clinical trial must fully understand the side effects and cautions specified in this
plan in advance, and if any serious side effects occur during the study, immediately
stop the clinical trial of the patient, take appropriate measures, and notify the
relevant review committee.
19.2 Approval and revision of clinical trial protocol In the case of obtaining approval of a
clinical trial or intending to perform a modified clinical trial, approval is obtained from
the Institutional Review Board.
19.3 Familiarity with the research plan The study manager and the person in charge accurately
analyze and understand the research plan, and actively respond to the subject's problems.
19.4 Clinical Trial Consent Before entering the clinical study, after explaining all the
contents and safety of the test to the subject, the subject himself/herself voluntarily
obtains consent to participate in this study and enters the study.
19.5 Selecting the correct subject Prior to this study, the suitability of the subject is
thoroughly evaluated. 19.6 Subject's Confidentiality Records that can identify the subject
will be kept confidential, and even if the results of the clinical trial are published, the
subject's identity will be kept confidential.
All documents related to clinical trials, such as case records, should be recorded and
classified with the subject identification code (usually the patient's initial), not the
patient name.
19.7 Clinical trial drug management : None. 19.8 Action in case of adverse reaction In the
event of an adverse reaction, it is managed to receive the necessary examination and
treatment from the doctor in charge immediately.
In the case of subjects with adverse reactions, the safety of the subjects shall be confirmed
by continuing monitoring for adverse reactions by phone call from the investigator or by
visiting the subject's outpatient clinic until the symptoms are treated, and the duration
shall be recorded in the case record.
12. Other matters necessary to safely and scientifically conduct clinical trials
1. Change of clinical trial protocol The purpose of the study, study design, patient
population, number of subjects, and changes to the study protocol, including changes to
the study procedure, and the benefits of the study, or changes to the clinical trial
protocol that may affect the safety of the patient, are not official. The plan needs to
be changed. These changes must be approved by the IRB prior to implementation.
2. Storage of data The head of the testing institution shall appoint a person in charge of
storage for five years from the date of completion of the clinical trial, unless the
retention period is specifically determined by other laws and regulations among records
and data handed over from the review committee and the research manager. In addition,
measures should be taken to prevent these data from being damaged or lost early due to
accidents, etc.
3. Researcher's Duties
1. Clinical trial records and supporting documents Researchers must preserve all
clinical trial related documents, including all communication related to the study,
patient records, consent, records of use and administration of all clinical trial
drugs, and copies of case records, and ensure that these documents are not damaged
or lost early due to accidents, etc. . However, after the completion of the result
report (if the fact-finding investigation by the head of the Korea Food and Drug
Administration is necessary, the investigation is completed), these documents must
be handed over to the person in charge of storage of a separately determined
testing institution.
2. Modification of clinical trial protocol The investigator cannot modify this
clinical trial protocol during the trial without the consent of the other party. If
participants wish to approve a change in the clinical trial protocol, the IRB will
approve the change protocol.
3. Disclosure of data Individual patient medical information obtained as a result of
this study is considered confidential, and disclosure to third parties is
prohibited except as specified below. However, medical information may be provided
to the patient's individual physician or other appropriate health care provider
responsible for the patient's well-being. Data generated as a result of this study
will be disclosed to the Institutional Review Board or regulatory authority for due
diligence upon request
