Performance and Tolerance of ColonoscopyNCT04383132
Effectiveness of Abdominal Binder Use During Colonoscopy
A study testing Abdominal Binder in people with Performance and Tolerance of Colonoscopy, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Performance and Tolerance of Colonoscopy
- What is being tested?
- Abdominal Binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Istanbul, 34785
About this study
Official title: Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial
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.
- Conditions
- Performance and Tolerance of Colonoscopy
- Being tested
- Abdominal Binder
- Keywords
- abdominal binder, colonoscopy, loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal BinderDevice
abdominal binder is a kind of elastic abdominal compression device
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Binder Intervention Group | Experimental | 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. Receives: Device: Abdominal Binder |
| Sham Group | Sham comparator | 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 Receives: Device: Abdominal Binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes
Secondary outcomes (6)
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.
Measured: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes
Length of Cecal Intubation
The length of the colonoscope required to reach the cecum from the anus will be measured
Measured: From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes
Number of Participants Who Completed the Procedure
Dichotomous outcome indicating if the procedure was incomplete or complete.
Measured: 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
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
Measured: 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
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) )
Measured: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes
Number of Participants According to Colonoscopy Findings
Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 May 2020
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Performance and Tolerance of ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beslen Goksoy, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Investigators
- Beslen Göksoy, M.D., Principal investigator, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383132
- Sponsor's protocol ID
- Beslen-korse
- Status last verified
- Oct 2020
- First submitted
- 4 May 2020
- Last updated
- 12 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT04383132
- Acronym / sponsor ID
- Beslen-korse
- Conditions
- Performance and Tolerance of Colonoscopy
- Keywords
- abdominal binder, colonoscopy, loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Posted 12 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Binder Intervention Group | Experimental | Device: Abdominal BinderPatients 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. |
| Sham Group | Sham comparator | Device: Abdominal BinderSham 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Binderabdominal binder is a kind of elastic abdominal compression device | Device | Abdominal Binder Intervention Group, Sham Group |
Primary outcome
Mean Cecal Intubation Time
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
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
6 secondary outcomes
Number of Participants Who Required Ancillary Maneuvers
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
Length of Cecal Intubation
Time frame: From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes
Number of Participants Who Completed the Procedure
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
Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug
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
Patient Pain and Comfort Level at Discharge
Time frame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes
Number of Participants According to Colonoscopy Findings
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beslen Göksoy, M.D. principal investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Binder in people with Performance and Tolerance of Colonoscopy, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Cecal Intubation Time (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.