Trial Title:
Left Lateral Position Versus Supine Position in Colonoscopy
NCT ID:
NCT06664762
Condition:
Colorectal Cancer Screening
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
multicenter single-blind randomized clinical trial study
Primary purpose:
Screening
Masking:
Single (Care Provider)
Masking description:
The main investigators will be in charge of randomizing all the patients ellegible for
this protocol, and the care providers and endoscopists will be masked when it comes to
knowing to which arm of the study each patient belongs to, untill the moment they need to
perform the colonoscopy.
Intervention:
Intervention type:
Behavioral
Intervention name:
Left lateral position intervention
Description:
Patients will be randomized and asigned to start and remain in left lateral position
during the colonoscopy
Arm group label:
Left lateral position during colonoscopy
Intervention type:
Behavioral
Intervention name:
Supine position intervention
Description:
Patients will be randomized and asigned to start and remain in supine position during the
colonoscopy
Arm group label:
Supine position during colonoscopy
Summary:
Currently, colonoscopy is a minimally invasive method that can be used as a diagnostic
and therapeutic method by endoscopists, gastroenterologists and coloproctologists. Due to
the importance and big impact this method has, it is necessary to both optimize its
efficiency, and improve its quality, which is one of the main objectives of this
protocol.
By observing which position its faster and which one also results in fewer complications
when performing a colonoscopy without reducing its performance and following all the
internationally established quality standards regarding colonoscoscopy.
The risk of this protocol implies a risk no greater than the minumum the procedure itself
has, and does not generate extra cost for all of the patients subjected to this protocol.
Detailed description:
Currently, colonoscopy is one of the most used procedures when it comes to the study and
treatment of patients with gastrointestinal conditions, including colorectal cancer,
inflammatory bowel disease, etc.
In the area of colorectal neoplasia, colonoscopy has three main functions, which are to
diagnose the desease itself and prevent its development by detecting and eliminating
potentially premalignant lesions, as well as providing a diagnosis of cancer at an early
stage.
The effectiveness of colonoscopy is crucial to carry out an accurate examination of the
entire colorectal mucosa, which is why the quality of the procedure has been a subject of
study in recent years. Among multiple factors that influence the quality of
colonoscopies, the investigators can mention intestinal preparation, which is essential
for an accurate procedure, because if patients have an inadequate preparation, it could
impair the detection of lesions, since usually, in patients with little or no
preparation, colonoscopy can be either incomplete, which requires the study to be
repeated, or in case the study continues despite poor intestinal preparation, the
presence of feces implies poor visualization of the colonic mucosa, which reduces the
ability to detect lesions such as polyps, especially if they are <5 mm. Therefore, the
type of solution and tolerability, the preparation regimen and the moment in which the
intestinal preparation is performed are considerations to evaluate when performing a
colonoscopy.
The position during the colonoscopy is another factor that can influence colonoscopy´s
effectiveness, and also, the main focus for the investigators to study. Traditionally, if
no position changes occur during colonoscopy, it begins and ends in the left lateral
position. However, recent evidence suggests that supine position may reduce the
disadvantages of the left lateral position, through decreased frequency of position
changes and decreased abdominal pressure, which may result in an easier endoscope
insertion in supine position when comparing it to left lateral position, however, there
is very few information on the optimal insertion technique in colonoscopy, but it has
been observed that in left lateral position, the air leaves the left colon causing it to
collapse and also creating sharp curves that can be difficult to overcome during the
procedure.
As previously mentioned, colonoscopy insertion is technically challenging, and one of the
few clinical trials available that targeted the determination of optimal patient
positioning during colonoscopy insertion compared the supine starting position with the
left lateral starting position, and the investigators found that cecal intubation times
decreased and patient comfort scores improved when using the supine position.
Therefore, patient positioning in colonoscopy has been proposed as a simple and
inexpensive technique to increase luminal distension and improve navigation through the
colon. Based on what has been mentioned before, using the initial supine position could
be a convenient method to reduce cecal intubation time, reduce pain, and improve
acceptance of colonoscopy among patients. However, more research is necessary in this
area to stablish the advantages of the initial supine position over other positions thar
are classically used.
Based on everything that has been described above, the investigators asked themselves the
following research question to start this clinical trial: Is there a significant
difference in the effectiveness and comfort of performing colonoscopy, when comparing the
left lateral position with the supine position?
The institutes where this clinical trial will take place have subjects for study that are
ellegible to enroll as participants, infraestructure and health care providers trained to
perform colonoscopies and a complete investigators team to collect and analyze the data
for this protocol.
The protocol will be limited only to patients who are beneficiaries of each of the
hospitals involved. Furthermore, as it is a single-blind randomized clinical trial, the
endoscopists in the study cannot be blinded, so investigator bias will not be excluded.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with indication for colonoscopy in our coloproctology service
- Both women and men
- Patients within an age range of 18-79 years
- Patients who agree having a colonoscopy and who sign the informed consent to
participate in the protocol
Exclusion Criteria:
- Patients under 18 or over 80 years old
- All patients that won´t like to participate in the protocol or won´t sign the
informed consent
- Pregnant women
- Patients with a medical record of colonic resection, ostomy status, severe
cardiopulmonary and renal diseases, major psychiatric disorders, therapeutic
colonoscopy or any contraindications for colonoscopy
- Non compliance with the colonic preparation regimen
- Active bleeding during the procedure
- Patients with a known diagnosis of colorectal cancer
- Patients with class III obesity
Elimination criteria:
- Boston score <6 for colonic preparation
- Patients with a colonic lesion that makes it difficult to pass the colonoscope
- Patients with insufficient sedation that requires the procedure to stop temporarily
- Bowel perforation during colonoscopy
- Inability to reach the cecum despite loop reduction maneuvers
- Indication to suspend the study given by the anesthesiologist
Gender:
All
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Address:
City:
Guadalajara
Zip:
44200
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Roberto U. Cruz Neri, M. C.
Phone:
+52 3311946664
Email:
robertocruzneri@gmail.com
Contact backup:
Last name:
Roberto U. Cruz Neri, M. C.
Contact backup:
Last name:
Athziri Buenrostro Fernández, M. C.
Contact backup:
Last name:
Francisco J. Valadez Correa, M. C.
Contact backup:
Last name:
José A. González Duarte, M. C.
Contact backup:
Last name:
Florisa Hernández Gómez, M. C.
Contact backup:
Last name:
Milton M. Salas Nuñez, M. C.
Contact backup:
Last name:
José C. Gomar González, M. C.
Contact backup:
Last name:
Carolina Vázquez Iñiguez, M. C.
Contact backup:
Last name:
María L. López Ibañez, M. C.
Facility:
Name:
Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
Address:
City:
Guadalajara
Zip:
44340
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Jesús A Valenzuela Pérez, M. C.
Phone:
+52 3331497976
Email:
dr_jvalenzuela@hotmail.com
Contact backup:
Last name:
Jesús A. Valenzuela Pérez, M.C.
Facility:
Name:
IMSS Hospital General Regional 220 "José Vicente Villada"
Address:
City:
Mexico
Zip:
50150
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Carlos H Sandoval Jiménez, M. C.
Phone:
+52 7225121556
Email:
drmasaju@gmail.com
Contact backup:
Last name:
Carlos H. Sandoval Jiménez, M. C.
Start date:
August 27, 2024
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Hospital Civil de Guadalajara
Agency class:
Other
Collaborator:
Agency:
Hospital Civil Juan I. Menchaca
Agency class:
Other
Collaborator:
Agency:
Instituto Mexicano del Seguro Social
Agency class:
Other
Source:
Hospital Civil de Guadalajara
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06664762
