Performance of Colonoscopy, Tolerance of Colonoscopy
Conditions
Keywords
abdominal binder, colonoscopy, looping
Brief summary
This randomized trial will be conducted to evaluate the effectiveness and safety of an abdominal binder use during colonoscopy performed by gastrointestinal endoscopy fellow trainees. The investigators hypothesized that the abdominal binder use would facilitate and increase the effectiveness of the colonoscopy for inexperienced operators.
Detailed description
It will be a randomized, double-blind, sham-controlled study. The trial will be performed at a single-center, Hospital Central Norte PEMEX, a tertiary center with a gastrointestinal endoscopy fellow trainee program with more than 10 years of experience. This trial will be conducted in accordance with the most recent version of the Declaration of Helsinki. The trial has been approved by the local ethical committee and research committee with the number DCAS-SSS GSM-HCN-INV-0043-2022. Written informed consent will be obtained from all the patients before participation. This manuscript will be reported in accordance with CONSORT guidelines. Prior to the procedure, age, sex, height, weight, waist circumference (WC), body mass index (BMI), and colonoscopy indication of all participants will be recorded. Once enrolled, patients will be randomized to either the abdominal binder (AB) group or the sham binder (SB) group in a 1:1 ratio. Randomization will be performed using a web-based computer system (Research Randomizer, Geoffrey C. Urbaniak and Scott Plous) by an independent statistician who had no other intervention in the study. An independent operator will print the randomization number and group for each participant (either the AB or SB group) in individual cards, which will be hidden in a locked black box by the same independent operator. Only the nurse, who will fit the abdominal binder to all the patients in a private space, will have access to the cards. Randomized data and cards will be concealed to study coordinators, endoscopists, clinical staff, and participants. The abdominal binder to be used for the patients allocated in the AB group was the Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). Its price is $29.96. The device is manufactured in two sizes, One Size and X-Large. For the patients with a waist circumference \>110 cm it will be used the X-Large model. The three belts that make up the binder will be fitted to all the participants. Once placed, the binder will be adjusted to be located between the subcostal border and the anterior superior iliac spine. The participants will be asked to confirm that the binder is fastened tightly but not uncomfortably. For the participants in the SB group the same binder will be fitted, but once the patient is sedated, it will be loosened by the same nurse. The participants will wear a non-transparent gown over the binder so that it will not be visible to the endoscopists. Bowel preparation with 4 L of polyethylene glycol solution in split-dose (2 L in the afternoon of the day before and 5 h before the colonoscopy) will be used in all the participants. In this trial, all colonoscopy procedures will be performed by two second-year fellow trainees in gastrointestinal endoscopy. A standard video-colonoscope (EC-3890Li, PENTAX Co., Tokyo, Japan) will be used. All the patients will be placed in the left lateral decubitus position. Manual abdominal compression and postural change will be conducted by a technician when required by the endoscopy trainee or the attending endoscopist. Endoscopist or anesthesiology will be allowed to remove the binder at any time during the procedure if they resolve it was necessary for safety. Air insufflation will be used during colonoscopy. Sample size was estimated over the primary outcome of the study based on pre-experimental data estimation and previously reported CIT and SD of similar studies with fellows' participation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT (SD 110 sec), with 90% power and two-side alpha 0.05. Moreover, it was also calculated based on the frequency of ancillary maneuvers, using pre-experimental data estimation and literature data. It was found that 186 participants (93 per group) were needed to detect a 20% reduction in the use of ancillary maneuvers, with 90% power and two-side alpha 0.05. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients, 103 in each group were included in the study. Descriptive statistical analysis, including mean, mode, and frequencies will be performed for the description of the study data. The comparative analysis of the quantitative data will be previously subjected to normality evaluation by the Shapiro-Wilk test and graphical analyses. According to the normality, data comparative analysis will be performed either with a two-way Student's test or U Mann-Whitney test. For the comparative analyses of the categorical data (e.g., manual abdominal compression, postural change, need for intervention by the attending endoscopist) will be used chi-square or Fisher' exact test. A p value of \<0.05 will be accepted as statistical significance. Statistical inferential analysis will be performed using RStudio® (R Core Team v.1.2.5033; R Foundation for Statistical Computing, Vienna, Austria) and SPSS® Statistics for Windows Version 23.0 (IBM Corp., Armonk, NY, USA). RStudio® (R Core Team v.1.2.5033) will be also used for drawing graphics. The study biostatistician (SA) will be blinded to the randomization phase and recollection data process.
Interventions
DEVICEAbdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt)
Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). An abdominal binder is a kind of elastic abdominal compression device
DEVICELoose abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt)
Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). An abdominal binder is a kind of elastic abdominal compression device. It will be loosened just prior the procedure.
Sponsors
Hospital Central Norte PEMEX
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomization will be performed using a web-based computer system (Research Randomizer, Geoffrey C. Urbaniak and Scott Plous) by an independent statistician who had no other intervention in the study. An independent operator will print the randomization number and group for each participant (either the AB or SB group) in individual cards, which will be hidden in a locked black box by the same independent operator. Only the nurse, who will fit the abdominal binder to all the patients in a private space, will have access to the cards. Randomized data and cards will be concealed to study coordinators, endoscopists, clinical staff, and participants. For the participants in the SB group the same binder will be fitted, but once the patient is sedated, it will be loosened by the same nurse. The participants will wear a non-transparent gown over the binder so that it will not be visible to the endoscopists.
Intervention model description
Once enrolled, patients will be randomized to either the abdominal binder (AB) group or the sham binder (SB) group in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female adults between the ages of 20-80 * Participants with ASA I-III (American Society of Anesthesiologists Class) * Undergoing a colonoscopy at any of the study locations for: I. CRC screening (first colonoscopy or 10 years follow up of negative exam). II. Surveillance (prior colonoscopy with polyps). III. Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding. \- Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure and describe adequate cleansing.
Exclusion criteria
* Inability to provide informed consent. * Patients with known or suspected pregnancy. * Patients undergoing multiple procedures (e.g., upper and lower endoscopy). * Previous colon resection surgery. * History of problems with sedation or anesthesia. * Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease). * Patients with a history of colorectal cancer or other intra-abdominal malignancy. * Patients with open or recent wounds or skin rash on the anterior abdominal wall. * History of cirrhosis or ascites. * Patients who are medically unstable (American Society of Anesthesiology Class IV or above).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Cecal Intubation Time | During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes. | Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Use of Abdominal Pressure | During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes. | Binary data indicating individually when the abdominal pressure was used during the insertion phase of the procedure will be recorded. |
| Length of Cecal Intubation | During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes. | The length of the colonoscope required to reach de cecum from the anus will be measured. |
| Colonoscopy Completion Rate | During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes. | Dichotomous outcome indicating if the procedure was complete. |
| Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees | Immediately following completion of procedure when scope is removed from rectum, an average of 10 minutes after completion of the procedure. | Immediately following completion of procedure, the study assistant will obtain the trainee's assessment of procedural difficulty according to three grades of severity: mild, moderate, and severe. \*We found the 5-point scale more difficult to use in the dynamic of the endoscopy room. The Operator's Assessment of Procedural Difficulty scale was not used. The difficulty was rated as mild when the colonoscope was smoothly inserted, moderate when there were some difficulties quickly solved (less than 60 seconds), and severe when the difficulties were more difficult requiring a longer time (more than 60 seconds). |
| Number of Participants According to Colonoscopy Findings | During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes. | Findings such as polyps, cancer, diverticulum, and IBD (inflammatory bowel disease) detected during colonoscopy will be recorded. |
| Frequency of Intervention by the Attending Endoscopist | During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes. | Binary data indicating individually if intervention by the attending endoscopist was required during the insertion phase of the procedure will be recorded. |
| Additional Analgesic Drug Required to Complete Procedure | During colonoscopy, from time point of insertion of scope into de rectum to point in time when scope is removed from rectum, an average of 30 minutes. | Whether the patient needs an additional dose of analgesic drug to complete the colonoscopy. |
| Patient Pain at Discharge | At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility, an average of 90 minutes after completion of the procedure. | The study assistant will interview patient just prior to discharge and obtain responses for pain according to a 10-point visual analog scale. The Visual analogue scale (VAS) will be used. It is a pain grading scale ranging from 0 to 10 points, with 0 if no pain and 10 if worst pain possible. |
| Patient Satisfaction at Discharge | At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility, an average of 90 minutes after completion of the procedure. | The study assistant will interview patient just prior to discharge and obtain responses for satisfaction according to a 5-point Likert scale. The Satisfaction Likert scale will be used. It is a satisfaction grading scale ranging from 1 to 5 points, with 1 if very poor satisfaction and 5 if excellent satisfaction. |
| Frequency of Use of Position Change | During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes. | Binary data indicating when the patient position change was used during the insertion phase of the procedure will be recorded. |
| Additional Anesthetic Drug Required to Complete Procedure | During colonoscopy, from time point of insertion of scope into de rectum to point in time when scope is removed from rectum, an average of 30 minutes. | Whether the patient needs an additional dose of anesthetic drug to complete the colonoscopy. |
| Operator Perception of Patient Discomfort | Immediately following completion of procedure when scope is removed from rectum, an average of 10 minutes after completion of the procedure. | Immediately following completion of procedure, the study assistant will obtain operator's perception of patient discomfort during procedure according to the Gloucester score. The Gloucester score will be used. It is a comfort grading scale ranging from 1 to 5 points, with 1 point if no discomfort is present during the colonoscopy and 5 if there is extreme discomfort during the colonoscopy. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abdominal Binder Intervention Group Patients randomized to the Abdominal Binder Intervention Group will have the abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt) secured firmly between the subcostal border and the anterior superior iliac spine area to the abdomen just prior the colonoscopy. | 105 |
| Sham Group Sham Group will have the abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt) secured firmly between the subcostal border and the anterior superior iliac spine area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure. | 106 |
| Total | 211 |
Baseline characteristics
| Characteristic | Abdominal Binder Intervention Group | Total | Sham Group |
|---|---|---|---|
| Age, Continuous | 63.36 years STANDARD_DEVIATION 11.98 | 64.35 years STANDARD_DEVIATION 12.17 | 65.33 years STANDARD_DEVIATION 12.34 |
| Body Mass Index (IBM) | 29 kg/m^2 | 28.4 kg/m^2 | 27.4 kg/m^2 |
| Height | 1.64 meter STANDARD_DEVIATION 0.09 | 1.64 meter STANDARD_DEVIATION 0.08 | 1.64 meter STANDARD_DEVIATION 0.07 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Mexico | 105 participants | 211 participants | 106 participants |
| Sex: Female, Male Female | 62 Participants | 129 Participants | 67 Participants |
| Sex: Female, Male Male | 43 Participants | 82 Participants | 39 Participants |
| Weight | 78.44 kilogram STANDARD_DEVIATION 15.93 | 76.42 kilogram STANDARD_DEVIATION 15.05 | 74.42 kilogram STANDARD_DEVIATION 13.92 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 106 |
| other Total, other adverse events | 0 / 105 | 0 / 106 |
| serious Total, serious adverse events | 0 / 105 | 0 / 106 |
Outcome results
Primary
Mean Cecal Intubation Time
Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
Population: 8 participants with incomplete colonoscopy were excluded from the primary outcome analysis (intervention group n 4, sham group n 4).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abdominal Binder Intervention Group | Mean Cecal Intubation Time | 728 second |
| Sham Group | Mean Cecal Intubation Time | 774 second |
p-value: 0.008Wilcoxon (Mann-Whitney)
Secondary
Additional Analgesic Drug Required to Complete Procedure
Whether the patient needs an additional dose of analgesic drug to complete the colonoscopy.
Time frame: During colonoscopy, from time point of insertion of scope into de rectum to point in time when scope is removed from rectum, an average of 30 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Additional Analgesic Drug Required to Complete Procedure | 0 Participants |
| Sham Group | Additional Analgesic Drug Required to Complete Procedure | 4 Participants |
p-value: 0.12Fisher Exact
Secondary
Additional Anesthetic Drug Required to Complete Procedure
Whether the patient needs an additional dose of anesthetic drug to complete the colonoscopy.
Time frame: During colonoscopy, from time point of insertion of scope into de rectum to point in time when scope is removed from rectum, an average of 30 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Additional Anesthetic Drug Required to Complete Procedure | 0 Participants |
| Sham Group | Additional Anesthetic Drug Required to Complete Procedure | 0 Participants |
p-value: 1Fisher Exact
Secondary
Colonoscopy Completion Rate
Dichotomous outcome indicating if the procedure was complete.
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Colonoscopy Completion Rate | 100 Participants |
| Sham Group | Colonoscopy Completion Rate | 102 Participants |
p-value: 0.75Fisher Exact
Secondary
Frequency of Intervention by the Attending Endoscopist
Binary data indicating individually if intervention by the attending endoscopist was required during the insertion phase of the procedure will be recorded.
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Frequency of Intervention by the Attending Endoscopist | 6 Participants |
| Sham Group | Frequency of Intervention by the Attending Endoscopist | 11 Participants |
p-value: 0.321Chi-squared
Secondary
Frequency of Use of Abdominal Pressure
Binary data indicating individually when the abdominal pressure was used during the insertion phase of the procedure will be recorded.
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Frequency of Use of Abdominal Pressure | 15 Participants |
| Sham Group | Frequency of Use of Abdominal Pressure | 58 Participants |
p-value: <0.001Chi-squared
Secondary
Frequency of Use of Position Change
Binary data indicating when the patient position change was used during the insertion phase of the procedure will be recorded.
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Frequency of Use of Position Change | 2 Participants |
| Sham Group | Frequency of Use of Position Change | 12 Participants |
p-value: 0.01Chi-squared
Secondary
Length of Cecal Intubation
The length of the colonoscope required to reach de cecum from the anus will be measured.
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
Population: Participants with incomplete colonoscopy were excluded from two of the main secondary outcomes (CIL and IVIT).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abdominal Binder Intervention Group | Length of Cecal Intubation | 95 centimeter |
| Sham Group | Length of Cecal Intubation | 100 centimeter |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Number of Participants According to Colonoscopy Findings
Findings such as polyps, cancer, diverticulum, and IBD (inflammatory bowel disease) detected during colonoscopy will be recorded.
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | Polyps | 36 Participants |
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | Diverticulosis | 42 Participants |
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | Colon Cancer | 0 Participants |
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | IBD | 1 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | IBD | 0 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | Polyps | 30 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | Colon Cancer | 1 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | Diverticulosis | 44 Participants |
p-value: 0.8Fisher Exact
Secondary
Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees
Immediately following completion of procedure, the study assistant will obtain the trainee's assessment of procedural difficulty according to three grades of severity: mild, moderate, and severe. \*We found the 5-point scale more difficult to use in the dynamic of the endoscopy room. The Operator's Assessment of Procedural Difficulty scale was not used. The difficulty was rated as mild when the colonoscope was smoothly inserted, moderate when there were some difficulties quickly solved (less than 60 seconds), and severe when the difficulties were more difficult requiring a longer time (more than 60 seconds).
Time frame: Immediately following completion of procedure when scope is removed from rectum, an average of 10 minutes after completion of the procedure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Binder Intervention Group | Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees | Mild | 61 Participants |
| Abdominal Binder Intervention Group | Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees | Moderate | 38 Participants |
| Abdominal Binder Intervention Group | Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees | Severe | 6 Participants |
| Sham Group | Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees | Mild | 64 Participants |
| Sham Group | Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees | Moderate | 23 Participants |
| Sham Group | Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees | Severe | 19 Participants |
p-value: 0.005Chi-squared
Secondary
Operator Perception of Patient Discomfort
Immediately following completion of procedure, the study assistant will obtain operator's perception of patient discomfort during procedure according to the Gloucester score. The Gloucester score will be used. It is a comfort grading scale ranging from 1 to 5 points, with 1 point if no discomfort is present during the colonoscopy and 5 if there is extreme discomfort during the colonoscopy.
Time frame: Immediately following completion of procedure when scope is removed from rectum, an average of 10 minutes after completion of the procedure.
Population: We found the use of the Gloucester score difficult and subjective to use in the clinical scenario. The operators rated the episodes of discomfort in different ways, showing since the beginning a lack of consistency. The operator perception of patient discomfort was not evaluated. The data of this outcome were not collected for any patient.
Secondary
Patient Pain at Discharge
The study assistant will interview patient just prior to discharge and obtain responses for pain according to a 10-point visual analog scale. The Visual analogue scale (VAS) will be used. It is a pain grading scale ranging from 0 to 10 points, with 0 if no pain and 10 if worst pain possible.
Time frame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility, an average of 90 minutes after completion of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Binder Intervention Group | Patient Pain at Discharge | 2.22 score on a scale | Standard Deviation 0.89 |
| Sham Group | Patient Pain at Discharge | 3.58 score on a scale | Standard Deviation 0.88 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Patient Satisfaction at Discharge
The study assistant will interview patient just prior to discharge and obtain responses for satisfaction according to a 5-point Likert scale. The Satisfaction Likert scale will be used. It is a satisfaction grading scale ranging from 1 to 5 points, with 1 if very poor satisfaction and 5 if excellent satisfaction.
Time frame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility, an average of 90 minutes after completion of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Binder Intervention Group | Patient Satisfaction at Discharge | 3.65 score on a scale | Standard Deviation 0.78 |
| Sham Group | Patient Satisfaction at Discharge | 3.05 score on a scale | Standard Deviation 0.88 |
p-value: <0.001Wilcoxon (Mann-Whitney)