Performance and Tolerance of Colonoscopy
Conditions
Keywords
abdominal binder, colonoscopy, loop
Brief summary
Colonoscopy is considered the primary screening test for colorectal cancer screening worldwide. For technical difficulties previously experienced during colonoscopy, especially loop of the colonoscopy device in the colon, many solution methods have been developed and applied (manual pressure and position change, etc.). Although these methods are partially successful, there is no consensus on the optimum solution method. Few studies in the literature have investigated the use of corset during colonoscopy and conflicting results have been reported. In this study, elastic abdominal corset or false corset will be used during colonoscopy. Indeed, the investigators aim to determine whether this method is effective and safe with their own results and contribute to the literature. The primary outcome of this study will be the cecal intubation time. Secondary outcomes include manual pressure and position change during the procedure, length of cecal intubation (length of colonoscope required to reach the cecum from the anus), colonoscopy completion rate, additional anesthesia and / or analgesic requirement, patient pain and comfort level and colonoscopic findings.Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.
Interventions
DEVICEAbdominal Binder
abdominal binder is a kind of elastic abdominal compression device
Sponsors
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Between the ages of 18 - 90 Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing. Participants with ASA I-III (American Society of Anesthesiologists Class III)
Exclusion criteria
Previous colon resection History of intra-abdominal malignancy Known anesthetic or analgesic drugs allergy Multiple planned procedures (e.g.bidirectional endoscopy) Pregnancy Active inflammatory bowel disease A history of intraabdominal malignancy History of cirrhosis or ascites Known ventral hernia
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 cecum is identified,an average of 1-30 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 |
|---|---|---|
| Length of Cecal Intubation | From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes | The length of the colonoscope required to reach the cecum from the anus will be measured |
| Number of Participants Who Completed the Procedure | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes | Dichotomous outcome indicating if the procedure was incomplete or complete. |
| Number of Participants Who Required Ancillary Maneuvers | During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes | Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded. |
| Patient Pain and Comfort Level at Discharge | At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes | Study assistant will interview patient just prior to discharge and obtain responses for pain according to 10-point visual analog scales ( scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain =1 (min) and worst pain=10 (max)) and global satisfaction according to a 5-point scale ( scores are recorded by making a handwritten mark on a 5-cm line that represents a continuum between very unsatisfied =1 (min) and very satisfied=5 (max) ) |
| Number of Participants According to Colonoscopy Findings | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes | Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded. |
| Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes | Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abdominal Binder Intervention Group Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.
Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device | 173 |
| Sham Group Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure
Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device | 173 |
| Total | 346 |
Baseline characteristics
| Characteristic | Sham Group | Abdominal Binder Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 52.57 years STANDARD_DEVIATION 12.41 | 50.53 years STANDARD_DEVIATION 12.3 | 51.55 years STANDARD_DEVIATION 12.38 |
| Body Mass Index (BMI) | 29.62 kg/m^2 STANDARD_DEVIATION 5.54 | 28.79 kg/m^2 STANDARD_DEVIATION 5.02 | 29.2 kg/m^2 STANDARD_DEVIATION 5.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 173 Participants | 173 Participants | 346 Participants |
| Sex: Female, Male Female | 108 Participants | 97 Participants | 205 Participants |
| Sex: Female, Male Male | 65 Participants | 76 Participants | 141 Participants |
| waist circumference (WC) | 103.26 cm STANDARD_DEVIATION 11.84 | 102.33 cm STANDARD_DEVIATION 10.67 | 102.8 cm STANDARD_DEVIATION 11.27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 173 | 0 / 173 |
| other Total, other adverse events | 0 / 173 | 0 / 173 |
| serious Total, serious adverse events | 0 / 173 | 0 / 173 |
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 cecum is identified,an average of 1-30 minutes
Population: 9 patients were excluded from analysis CIT and CIL because the incompleted procedure (intervention group n 4, sham group n 5). Because the procedure must be completed for CIT and CIL analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Binder Intervention Group | Mean Cecal Intubation Time | 240 sec | Standard Deviation 110 |
| Sham Group | Mean Cecal Intubation Time | 250 sec | Standard Deviation 115 |
Comparison: In sample size calculation, CIT and SD were used. It was found that 326 patients (163 per group) were required to detect a 60-second difference in CIT (SD 192 secs), with 80% power and two-sided alpha 0.05. The frequency of the auxiliary maneuvers was calculated that 324 patients were required for a 20% reduction in the auxiliary maneuvers. In case of becoming lost to follow up and withdrawal, the number of patients was expanded by 5%, and a total of 346 patients, were included in the study.p-value: 0.388t-test, 2 sided
Secondary
Length of Cecal Intubation
The length of the colonoscope required to reach the cecum from the anus will be measured
Time frame: From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes
Population: 9 patients were excluded from analysis CIT and CIL because the incompleted procedure (intervention group n 4, sham group n 5). Because the procedure must be completed for CIT and CIL analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdominal Binder Intervention Group | Length of Cecal Intubation | 89 cm | Standard Deviation 18 |
| Sham Group | Length of Cecal Intubation | 88.5 cm | Standard Deviation 15 |
p-value: 0.487t-test, 2 sided
Secondary
Number of Participants According to Colonoscopy Findings
Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.
Time frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | Polyps | 72 Participants |
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | IBD or colitis | 0 Participants |
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | No mucosal pathology | 38 Participants |
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | colon cancer | 3 Participants |
| Abdominal Binder Intervention Group | Number of Participants According to Colonoscopy Findings | Diverticulosis | 60 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | colon cancer | 0 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | Polyps | 70 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | No mucosal pathology | 42 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | IBD or colitis | 2 Participants |
| Sham Group | Number of Participants According to Colonoscopy Findings | Diverticulosis | 59 Participants |
p-value: 0.184Fisher Exact
Secondary
Number of Participants Who Completed the Procedure
Dichotomous outcome indicating if the procedure was incomplete or complete.
Time frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Number of Participants Who Completed the Procedure | 169 Participants |
| Sham Group | Number of Participants Who Completed the Procedure | 168 Participants |
p-value: 0.822Chi-squared
Secondary
Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug
Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy
Time frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug | 43 Participants |
| Sham Group | Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug | 64 Participants |
p-value: 0.016Chi-squared
Secondary
Number of Participants Who Required Ancillary Maneuvers
Binary data indicating individually whether abdominal pressure or 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 cecum is identified, an average of 1-30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Binder Intervention Group | Number of Participants Who Required Ancillary Maneuvers | 65 Participants |
| Sham Group | Number of Participants Who Required Ancillary Maneuvers | 85 Participants |
p-value: 0.069Chi-squared
Secondary
Patient Pain and Comfort Level at Discharge
Study assistant will interview patient just prior to discharge and obtain responses for pain according to 10-point visual analog scales ( scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain =1 (min) and worst pain=10 (max)) and global satisfaction according to a 5-point scale ( scores are recorded by making a handwritten mark on a 5-cm line that represents a continuum between very unsatisfied =1 (min) and very satisfied=5 (max) )
Time frame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abdominal Binder Intervention Group | Patient Pain and Comfort Level at Discharge | VAS score | 1.9 score on a scale | Standard Deviation 1.6 |
| Abdominal Binder Intervention Group | Patient Pain and Comfort Level at Discharge | patient satisfaction score | 1.7 score on a scale | Standard Deviation 0.9 |
| Sham Group | Patient Pain and Comfort Level at Discharge | VAS score | 3.3 score on a scale | Standard Deviation 1.8 |
| Sham Group | Patient Pain and Comfort Level at Discharge | patient satisfaction score | 1.7 score on a scale | Standard Deviation 0.9 |
p-value: 0.001t-test, 2 sided