ColonoscopyPICNCT01159886
Patient-posture and Ileal-intubation During Colonoscopy
A study testing Ileal intubation in people with Colonoscopy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Ileal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult (> 12y old) patients referred for colonoscopy
Who cannot join
- Acute fulminant colitis
- Acute Intestinal obstruction
- Suspected intestinal perforation
- Peritonitis
- Pregnancy
- Severe cardio-respiratory disease (ASA grade…)
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- Decompensated liver disease
- Recent pelvic or colonic surgery (in last 6 months)
- Large aortic or ileac artery aneurysm
- Human Immunodeficiency Virus Infection
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
School of Digestive and Liver Diseases (SDLD), IPGME & R, Kolkata
Kolkata, 700020
K Das
Kshaunish Das
About this study
Official title: Patient-posture and Ileal-intubation During Colonoscopy (PIC): a Randomized Controlled Open-label Trial
During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. However, there has been no randomized trial which has shown that a particular posture of the patient increases the success rate of ileoscopy. The present study will be carried out to determine the impact of the patient's posture (left lateral vs supine position) on success rate of ileal intubation.
- Conditions
- Colonoscopy
- Being tested
- Ileal intubation
- Keywords
- Tuberculosis, IBD, endoscopy
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileal intubationProcedure or surgery
Also called Ileoscopy
After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Partial suction and scope manoeuvres for ileal intubation will be allowed.
Use of anti-peristalsis agents, use of biopsy forceps, as a guidewire or an ''anchor'' to facilitate the IC- valve intubation, and intubation in the retroflexed position will not be allowed.
| Study group | Role | What they receive |
|---|---|---|
| left lateral | Active comparator | After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus position. Then terminal ileal intubation will be attempted. Receives: Procedure: Ileal intubation |
| supine | Active comparator | After confirmation of cecal intubation, patient will undergo randomization to the supine position. Then terminal ileal intubation will be attempted. Receives: Procedure: Ileal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ileal intubation achieved or not
After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Two points will be assessed: success in ileal intubation and time taken to intubate the ileum. If ileum is not intubated within 6 minutes, it will be considered as failed attempt.
Measured: After confirmation of cecal intubation for no more than 6 minutes
Secondary outcomes (4)
Time taken to intubate the ileum after cecal intubation
Measured: 6 minutes after cecal intubation and randomisation
Depth of ileal intubation
Measured: 2 minutes
Influence of endoscopist experience on successful ileal intubation
Measured: 6 minutes
Abnormal ileal findings
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- Kshaunish Das, MD, DM, Principal investigator, Associate Professor, Division of Gastroenterology, SDLD, IPGME & R, Kolkata-700020
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159886
- Sponsor's protocol ID
- SDLD001
- Acronym
- PIC
- Status last verified
- Jul 2010
- First submitted
- 9 Jul 2010
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-posture and Ileal-intubation During Colonoscopy (PIC): a Randomized Controlled Open-label Trial
- ClinicalTrials.gov ID
- NCT01159886
- Acronym / sponsor ID
- PIC / SDLD001
- Conditions
- Colonoscopy
- Keywords
- Tuberculosis, IBD, endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. However, there has been no randomized trial which has shown that a particular posture of the patient increases the success rate of ileoscopy. The present study will be carried out to determine the impact of the patient's posture (left lateral vs supine position) on success rate of ileal intubation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| left lateral | Active comparator | Procedure: Ileal intubationAfter confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus position. Then terminal ileal intubation will be attempted. |
| supine | Active comparator | Procedure: Ileal intubationAfter confirmation of cecal intubation, patient will undergo randomization to the supine position. Then terminal ileal intubation will be attempted. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult (> 12y old) patients referred for colonoscopy
Key exclusion criteria (11 listed)
- Acute fulminant colitis
- Acute Intestinal obstruction
- Suspected intestinal perforation
- Peritonitis
- Pregnancy
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 |
|---|---|---|
| Ileal intubationAlso: IleoscopyAfter confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Partial suction and scope manoeuvres for ileal intubation will be allowed. Use of anti-peristalsis agents, use of biopsy forceps, as a guidewire or an ''anchor'' to facilitate the IC- valve intubation, and intubation in the retroflexed position will not be allowed. | Procedure or surgery | left lateral, supine |
Primary outcome
Ileal intubation achieved or not
Time frame: After confirmation of cecal intubation for no more than 6 minutes
After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Two points will be assessed: success in ileal intubation and time taken to intubate the ileum. If ileum is not intubated within 6 minutes, it will be considered as failed attempt.
4 secondary outcomes
Time taken to intubate the ileum after cecal intubation
Time frame: 6 minutes after cecal intubation and randomisation
Depth of ileal intubation
Time frame: 2 minutes
Influence of endoscopist experience on successful ileal intubation
Time frame: 6 minutes
Abnormal ileal findings
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2010.
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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.
Kshaunish Das, MD, DM principal investigator
Associate Professor, Division of Gastroenterology, SDLD, IPGME & R, Kolkata-700020
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileal intubation in people with Colonoscopy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Jul 2010. 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 India. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kshaunish Das, MD, DM (+91 9830349787, dockdas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ileal intubation achieved or not (time frame: After confirmation of cecal intubation for no more than 6 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 Jul 2010; AzTrials last refreshed its copy on 6 Nov 2026.