Intestinal CancerPhase 4PEGOPNCT01887158
Efficacy of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection
A Phase 4 study testing Polyethylene glycol and Bisacodyl in people with Intestinal Cancer, run by Ospedale Santa Maria delle Croci at 2 sites in Italy.
Trial summary
Studies that have investigated different bowel preparations in patients with history of colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in this subgroup of patients is still unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Cancer
- What is being tested?
- Polyethylene glycol and Bisacodyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2013to Jun 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- ≥18 yrs old,
- Prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy
Who cannot join
- Inpatients
- Emergency Colonoscopy
- Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant
- Pregnant and/or lactating women
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Alessandro Mussetto
Ravenna, RA, 48100
Ospedale S.Maria delle Croci
Ravenna, RA, 48100
About this study
Official title: Phase 4 Study of Comparison of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection. A Prospective Randomized Controlled Trial.
Studies that have investigated different bowel preparations in patients with history of colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are the most popular and safest bowel preparation regimens, however the 4-Liter volume is often poorly tolerated. More recently, it has been shown that the use of a low volume preparation (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare the efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG preparation.
- Conditions
- Intestinal Cancer
- Being tested
- Polyethylene glycol, Bisacodyl
- Medical subject headings
- Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycolDrug
BisacodylDrug
| Study group | Role | What they receive |
|---|---|---|
| bisacodyl plus 2-Liter Polyethylene glycol | Active comparator | Patients randomized to the low-volume arm, will be invited to consume 2 sachets of Lovol-esse (Polyethylene glycol) in one liter of water at 8:00 PM the evening before the colonoscopy and 2 sachets in one liter of water 4 hours before their scheduled colonoscopy appointment; furthermore, the patients will be instructed to take three 5-mg tablets of bisacodyl the day before the procedure, at 5:00 PM. Receives: Drug: Polyethylene glycol; Drug: Bisacodyl |
| 4-Liter Polyethylene glycol | Active comparator | Patients assigned to the high-volume arm will be invited to consume 2 envelopes of Selg-esse 1000 (polyethylene glycol) in 2 litres of water and drink the resulting solution in about 2-3 hours starting at 6:00 PM the evening before the colonoscopy; the day of the procedure, starting 5 hours before the procedure, the patients will be invited to complete the preparation with 2 others envelopes of Selg-esse 1000 (polyethylene glycol) dissolved in 2 litres of water. Receives: Drug: Polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of bowel preparation rated according to a modified Ottawa bowel preparation scale
Measured: about 2 weeks after the randomization
Secondary outcomes (3)
Tolerability to the preparation (specific questionaire)
Tolerability will be assessed by using a questionnaire completed by the patients on arrival at the endoscopy unit before colonoscopy.
The patient acceptance/satisfaction to bowel preparation will be evaluated with the following question:
What is the extent of your disturbance due to bowel preparation? Severe (the bowel preparation assumption was stopped and not completed)(score 3) Moderate (bowel preparation assumption was stopped several times because of side effects but finally completed)(score 2) Mild (bowel preparation was completed without pauses but with some mild side effects)(score 1) No side effects (score 0)
Measured: participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization
safety (adverse event rate)
Safety will be evaluated through reported adverse events, physical examination and vital signs
Measured: participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization
Lesion detection (type and lesion detection rate/patient)
Polyps will be categorized as non-neoplastic or neoplastic (ie, adenomatous). Adenoma will be diagnosed by pathological evaluation of retrieved polyps. Adenomas will be considered advanced when they will be ≥10 mm in size, with villous architecture, high-grade dysplasia or intramucosal carcinoma (pTis), or 3 or more adenomas will be found. Invasive cancer will be considered when malignant cells will be observed beyond the muscularis mucosa. Size of adenoma will be obtained from both the colonoscopist's assessment and the pathology report, with the larger measurement being used in the analyses. Site of adenoma will be recorded by the colonoscopist at the time of polypectomy. Lesions at or proximal to the splenic flexure will be termed right-sided lesions, those distal to the splenic flexure as left-sided, taking into account the type of colorectal surgical resection underwent by the patient. The adenoma detection rate will be defined as the proportion of colonoscopies with adenomas.
Measured: about 2 weeks from the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Maria delle Croci
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Mussetto, Ospedale Santa Maria delle Croci
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887158
- Sponsor's protocol ID
- PEGOP0613
- Acronym
- PEGOP
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2013
- Last updated
- 17 Jun 2014
- Results posted
- No
Publications
Mussetto A, Frazzoni L, Paggi S, Dari S, Laterza L, Radaelli F, Hassan C, Triossi O, Fuccio L. Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial. Endoscopy. 2015 Oct;47(10):917-24. doi: 10.1055/s-0034-1391987. Epub 2015 Apr 24.
PubMed 25910064
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Comparison of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection. A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01887158
- Acronym / sponsor ID
- PEGOP / PEGOP0613
- Conditions
- Intestinal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ospedale Santa Maria delle CrociUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jun 2013 (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.
Studies that have investigated different bowel preparations in patients with history of colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are the most popular and safest bowel preparation regimens, however the 4-Liter volume is often poorly tolerated. More recently, it has been shown that the use of a low volume preparation (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare the efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bisacodyl plus 2-Liter Polyethylene glycol | Active comparator | Drug: Polyethylene glycol, Drug: BisacodylPatients randomized to the low-volume arm, will be invited to consume 2 sachets of Lovol-esse (Polyethylene glycol) in one liter of water at 8:00 PM the evening before the colonoscopy and 2 sachets in one liter of water 4 hours before their scheduled colonoscopy appointment; furthermore, the patients will be instructed to take three 5-mg tablets of bisacodyl the day before the procedure, at 5:00 PM. |
| 4-Liter Polyethylene glycol | Active comparator | Drug: Polyethylene glycolPatients assigned to the high-volume arm will be invited to consume 2 envelopes of Selg-esse 1000 (polyethylene glycol) in 2 litres of water and drink the resulting solution in about 2-3 hours starting at 6:00 PM the evening before the colonoscopy; the day of the procedure, starting 5 hours before the procedure, the patients will be invited to complete the preparation with 2 others envelopes of Selg-esse 1000 (polyethylene glycol) dissolved in 2 litres of water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients
- ≥18 yrs old,
- Prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy
Key exclusion criteria (4 listed)
- Inpatients
- Emergency Colonoscopy
- Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant
- Pregnant and/or lactating women
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 |
|---|---|---|
| Polyethylene glycol | Drug | 4-Liter Polyethylene glycol, bisacodyl plus 2-Liter Polyethylene glycol |
| Bisacodyl | Drug | bisacodyl plus 2-Liter Polyethylene glycol |
Primary outcome
quality of bowel preparation rated according to a modified Ottawa bowel preparation scale
Time frame: about 2 weeks after the randomization
3 secondary outcomes
Tolerability to the preparation (specific questionaire)
Time frame: participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization
safety (adverse event rate)
Time frame: participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization
Lesion detection (type and lesion detection rate/patient)
Time frame: about 2 weeks from the randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Derived from this study: PubMed 25910064Mussetto A, Frazzoni L, Paggi S, Dari S, Laterza L, Radaelli F, Hassan C, Triossi O, Fuccio L. Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial. Endoscopy. 2015 Oct;47(10):917-24. doi: 10.1055/s-0034-1391987. Epub 2015 Apr 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene glycol and Bisacodyl in people with Intestinal Cancer, run by Ospedale Santa Maria delle Croci at 2 sites in Italy.
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 3 inclusion and 4 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
quality of bowel preparation rated according to a modified Ottawa bowel preparation scale (time frame: about 2 weeks after the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01887158, which also lists 1 linked publication.
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 17 Jun 2014.