Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Civil Juan I. Menchaca | OTHER |
| Instituto Mexicano del Seguro Social | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left lateral position during colonoscopy | Active Comparator |
| |
| Supine position during colonoscopy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left lateral position intervention | Behavioral | Patients will be randomized and asigned to start and remain in left lateral position during the colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cecal Intubation. | Time since insertion to cecal intubation despite the position for colonoscopy | 4-10 minutes, which is approximately 240-600 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Adenoma Detected During Colonoscopy | Adenoma detection was defined as the identification of at least one histologically confirmed adenomatous polyp during the procedure. The percentage was calculated based on the total number of participants analyzed in each group. | During colonoscopy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Elimination criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde" | Guadalajara | Jalisco | 44200 | Mexico | ||
| Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11464632 | Background | de la Torre Bravo A. [The astonishing evolution of endoscopy]. Rev Gastroenterol Mex. 2001 Jan-Mar;66(1):58-9. No abstract available. Spanish. | |
| 9449087 | Background | Spaner SJ, Warnock GL. A brief history of endoscopy, laparoscopy, and laparoscopic surgery. J Laparoendosc Adv Surg Tech A. 1997 Dec;7(6):369-73. doi: 10.1089/lap.1997.7.369. |
Not provided
Not provided
150 patients were screened. Six did not meet eligibility criteria or declined participation. A total of 144 provided informed consent and were randomized 1:1 to start colonoscopy in left lateral decubitus or supine position.
Patients were recruited from two centers in Mexico: Hospital Civil "Fray Antonio Alcalde" (40 pts) and Hospital General Regional No. 220 (104 pts), between Aug 2024-Jul 2025. Eligible patients scheduled for colonoscopy were informed of the study, consented, and randomized. Recruitment was completed as planned.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Left Lateral Position During Colonoscopy | Participants randomized to this arm underwent colonoscopy starting in the left lateral decubitus (LLD) position, which is traditionally considered the standard initial position for the procedure. After informed consent, patients were positioned in LLD and the colonoscopy was initiated by experienced endoscopists using standard colonoscopes under routine clinical practice conditions. The objective was to evaluate the efficacy and safety of this position in terms of cecal intubation rate, time to reach the cecum, need for position changes or additional maneuvers, and polyp detection rate. If adequate visualization or advancement could not be achieved, position changes or abdominal pressure were permitted at the discretion of the endoscopist, and these adjustments were recorded. All patients received the same bowel preparation protocol and sedation standards, ensuring comparability with the supine group. |
| FG001 | Supine Position During Colonoscopy | Participants assigned to this arm underwent colonoscopy starting in the supine (SP) position. After informed consent, patients were placed supine on the examination table, and colonoscopy was initiated using standard equipment under routine clinical practice conditions. The purpose was to compare this alternative starting position with the traditional left lateral decubitus approach in terms of cecal intubation rate, time to reach the cecum, need for position changes, and polyp detection rate. The supine position has been proposed to improve visualization of the colonic mucosa and facilitate advancement of the colonoscope, particularly in the proximal colon. If insertion or visualization was suboptimal, the endoscopist could use abdominal pressure or change the patient's position as needed, with all such maneuvers documented. Patients in this arm followed the same bowel preparation, sedation, and monitoring protocols as those in the left lateral group, ensuring standardized conditions for direct comparison. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Eligible patients, according to established guidelines, were scheduled for colonoscopy and assigned a randomized number.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Left Lateral Position During Colonoscopy | Participants were randomized to the Left Lateral Decubitus (LLD) arm at the time of colonoscopy. Baseline characteristics collected for this group included age, sex, comorbidities, and bowel preparation quality assessed using a standardized bowel preparation scale. All baseline variables and measurements are presented in the corresponding results tables. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was measured in years at the time of colonoscopy. Results are reported as mean ± standard deviation (57.7 ± 12.2 years). Range: adult patients according to inclusion criteria. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Cecal Intubation. | Time since insertion to cecal intubation despite the position for colonoscopy | A total of 144 patients were included: 72 in the supine position and 72 in the lateral decubitus position. | Posted | Mean | Standard Deviation | Seconds | 4-10 minutes, which is approximately 240-600 seconds | Seconds | Seconds |
|
During the colonoscopy (procedure duration: approximately 20-60 minutes per participant).
Of the 144 participants studied, no adverse events or deaths were recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Left Lateral Position During Colonoscopy | Left lateral position at the begining of the procedure. |
Not provided
Not provided
The relatively small sample size per group may have limited the statistical power to detect subtle differences, and the absence of stratified analyses by hospital with respect to clinical variables (such as age and comorbidities) could have influenced both intubation time and procedure tolerance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Ulises Cruz Neri | Hospital Civil Antiguo de Guajadalara "Fray Antonio Alcalde" | 3311946664 | 0 | robertocruzneri@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2026 | Apr 24, 2026 | Prot_SAP_000.pdf |
Not provided
multicenter single-blind randomized clinical trial study
Not provided
Not provided
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.
| Supine position intervention | Behavioral | Patients will be randomized and asigned to start and remain in supine position during the colonoscopy |
|
| Guadalajara |
| Jalisco |
| 44340 |
| Mexico |
| IMSS Hospital General Regional 220 "José Vicente Villada" | México | Toluca de Lerdo | 50150 | Mexico |
| 22717798 | Background | Antoniou SA, Antoniou GA, Koutras C, Antoniou AI. Endoscopy and laparoscopy: a historical aspect of medical terminology. Surg Endosc. 2012 Dec;26(12):3650-4. doi: 10.1007/s00464-012-2389-y. Epub 2012 Jun 21. |
| 1586826 | Background | Irving MH, Catchpole B. ABC of colorectal diseases. Anatomy and physiology of the colon, rectum, and anus. BMJ. 1992 Apr 25;304(6834):1106-8. doi: 10.1136/bmj.304.6834.1106. No abstract available. |
| 16454841 | Background | van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x. |
| 25582839 | Background | Neilson LJ, Bevan R, Panter S, Thomas-Gibson S, Rees CJ. Terminal ileal intubation and biopsy in routine colonoscopy practice. Expert Rev Gastroenterol Hepatol. 2015 May;9(5):567-74. doi: 10.1586/17474124.2015.1001744. Epub 2015 Jan 12. |
| 26416195 | Background | Vergis N, McGrath AK, Stoddart CH, Hoare JM. Right Or Left in COLonoscopy (ROLCOL)? A Randomized Controlled Trial of Right- versus Left-Sided Starting Position in Colonoscopy. Am J Gastroenterol. 2015 Nov;110(11):1576-81. doi: 10.1038/ajg.2015.298. Epub 2015 Sep 29. |
| 28644314 | Background | Vergis N, Scarborough AJ, Morris JA, Hoare JM. Prone or Left for Colonoscopy? A Randomized Controlled Trial of Prone Versus Left-sided Starting Position for Colonoscopy. J Clin Gastroenterol. 2018 Nov/Dec;52(10):e82-e86. doi: 10.1097/MCG.0000000000000871. |
| 30660634 | Background | Zhao S, Yang X, Meng Q, Wang S, Fang J, Qian W, Xia T, Pan P, Wang Z, Gu L, Chang X, Zou D, Li Z, Bai Y. Impact of the supine position versus left horizontal position on colonoscopy insertion: a 2-center, randomized controlled trial. Gastrointest Endosc. 2019 Jun;89(6):1193-1201.e1. doi: 10.1016/j.gie.2019.01.009. Epub 2019 Jan 18. |
| 22381531 | Background | Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28. |
| 12510453 | Background | Cappell MS, Friedel D. The role of sigmoidoscopy and colonoscopy in the diagnosis and management of lower gastrointestinal disorders: technique, indications, and contraindications. Med Clin North Am. 2002 Nov;86(6):1217-52. doi: 10.1016/s0025-7125(02)00076-7. |
| 37197258 | Background | Gangwani MK, Aziz A, Dahiya DS, Nawras M, Aziz M, Inamdar S. History of colonoscopy and technological advances: a narrative review. Transl Gastroenterol Hepatol. 2023 Apr 20;8:18. doi: 10.21037/tgh-23-4. eCollection 2023. |
| 24267161 | Background | Church J. Colonoscopy: what are we missing? Surg Oncol Clin N Am. 2014 Jan;23(1):1-9. doi: 10.1016/j.soc.2013.09.001. Epub 2013 Nov 1. |
| 32458286 | Background | Greene A, Borgoankar M, Hodgkinson K, Garland C, Bacque L, Pace D. A randomized controlled trial comparing right and left lateral decubitus starting position on outcomes in colonoscopy. Surg Endosc. 2020 Aug;34(8):3656-3662. doi: 10.1007/s00464-020-07661-x. Epub 2020 May 26. |
| BG001 | Supine Position During Colonoscopy | Participants were randomized to the Supine Position (SP) arm at the time of colonoscopy. Baseline characteristics collected for this group included age, sex, comorbidities, indications for colonoscopy, and bowel preparation quality assessed using a standardized bowel preparation scale. All baseline variables and measurements are presented in the corresponding results tables. |
| BG002 | Total | Total of all reporting groups |
All randomized adult patients who underwent colonoscopy (N=144) were included in the analysis of age. |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Sex was recorded as reported by the patient at the time of enrollment. Data are presented as number and percentage of male and female participants. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Position during colonoscopy | Position during colonoscopy: Left Lateral Position Versus Supine Position | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Seconds |
|
|
| Secondary | Number of Participants With at Least One Adenoma Detected During Colonoscopy | Adenoma detection was defined as the identification of at least one histologically confirmed adenomatous polyp during the procedure. The percentage was calculated based on the total number of participants analyzed in each group. | Posted | Count of Participants | Participants | During colonoscopy |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Supine Position During Colonoscopy | Supine position at the begining of the procedure | 0 | 72 | 0 | 72 | 0 | 72 |
Not provided
Not provided