Colonoscopy PreparationPhase 4NCT02665624
Adding Stewed Apricot Juice to Senna Improves the Right-Side and Overall Colon Cleansing Quality for Colonoscopy Preparation
A Phase 4 study testing Senna and stewed apricot juice and Senna alone in people with Colonoscopy Preparation, run by Camlıca Erdem Hospital.
Trial summary
Adequate bowel cleansing is essential for optimal colonoscopic examination. However, none of the colonoscopy preparation regimens is safe, efficient and also comfortable. The investigators' aim was to determine whether adding stewed apricot juice to senna increases patient comfort and improves bowel cleansing during… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- Senna and stewed apricot juice and Senna alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients with either sex who were over 18 years of age and referred for elective colonoscopy were included in the study
Who cannot join
- history of renal, cardiac, hepatic and metabolic disease including diabetes mellitus
- history of colonic resection
- hospitalized patients
- pregnancy or breast-feeding
- history of inflammatory bowel disease
- known allergy to senna.
About this study
Adequate bowel cleansing is essential for optimal colonoscopic examination. However, none of the colonoscopy preparation regimens is safe, efficient and also comfortable. The investigators' aim was to determine whether adding stewed apricot juice to senna increases patient comfort and improves bowel cleansing during colonoscopy preparation.
Read the detailed description
- Colonoscopy is the current standard method for diagnosing colon cancer and polyps, and also can be used for therapeutic interventions such as polypectomy. Diagnostic accuracy and therapeutic safety of the procedure depends on the quality of the colonic cleansing. Inadequate bowel preparation may result in missed precancerous lesions, longer colonoscopy time, lower cecal intubation rates and increased electrocautery risks. It also causes further costs because the colonoscopy has to be re-scheduled or alternative examinations have to be planned.
- Although polyethylene glycol (PEG) and sodium phosphate (NaP) are the main cleansing solutions in current practice, they tend to be poorly tolerated. The need to intake a large volume of fluid and unpleasant, salty taste of PEG reduce patient compliance. To overcome these limitations, split-dose administration of PEG has been shown effective and more patient-friendly. Unfortunately, PEG solutions have not been available in some countries due to marketing problems, as in Turkey. The potential risks for clinically significant alterations in serum electrolyte levels and hemodynamic instability in patients with renal failure, congestive heart failure, uncontrolled hypertension and ascites limits the usage of NaP. Moreover, European Society of Gastrointestinal Endoscopy (ESGE) suggests that oral NaP can only be advised in selected cases such as patients unable to tolerate other agents or only individuals to be at low risk of NaP-related side-effects. Unfortunately, 20% of patients who consumed PEG or NaP did not have satisfactory bowel cleansing. Because of the limitations of NaP and unavailability of PEG solutions, senna is still the main colonoscopy preparation in some countries..
- The ideal colonoscopy preparation would not only reliably empty the colon, but also not cause any patient discomfort. However, none of the preparations currently meet all of these criteria. Thus, numerous clinical trials have assessed prokinetic and spasmolytic agents, ascorbic acid, olive oil, orange and pineapple juice to attempt to improve the effectiveness and tolerance of colonoscopic preparation regimens. Among these preparations, no additive effect was demonstrated for prokinetic and spasmolytic agents, while authors determined more patient satisfaction and colon cleansing for the rest.
- Senna alkaloids have a direct effect on intestinal mucosa, increasing the colonic motility, enhancing colonic transit, and inhibiting water and electrolyte secretion. Although senna were used effectively alone in the past, they have been replaced by PEG and NaP solutions. Senna have a good-taste and are well-tolerated, inexpensive and have fewer adverse effects, yet, their efficacy is controversial.
- Apricot (Prunus armeniaca L.) has an important place in human nutrition and can be used as fresh or dried. Also, traditionally dried apricots have been used for many years in Mediterranean countries as a remedy for constipation because of their high-fiber content . Furthermore, apricots contain sorbitol (4,6g/100g) which has a laxative effect and used for treating constipation in the elderly.
- Although these fruits are already in our life, to investigators knowledge, there is no study examining the effects of apricot juice for precolonoscopic preparation. Therefore, the investigators conducted this study to establish whether adding stewed apricot juice to senna promotes bowel cleansing as well as patient comfort.
- Conditions
- Colonoscopy Preparation
- Being tested
- Senna and stewed apricot juice, Senna alone
- Keywords
- Bowel cleansing, Colonoscopy, Stewed apricot juice, Senna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senna and stewed apricot juiceDrug
Also called X-M solution (300 mg sennoside A+B calcium, Yenisehir Pharmaceuticals), Stewed apricot juice made with dried apricot
comparison of bowel cleansing and patient comfort.
Senna aloneDrug
Also called X-M solution (300 mg sennoside A+B calcium, Yenisehir Pharmaceuticals)
comparison of bowel cleansing and patient comfort.
| Study group | Role | What they receive |
|---|---|---|
| Stewed apricot juice + senna group | Active comparator | 68 patients received 250 ml of Senna solution (containing 500 mg sennoside A+B calcium) (X-M solution, Yenisehir Pharmaceuticals, Turkey) at 6 PM on the day before colonoscopy, and at 6 AM on the day of the procedure. Additional one liter of stewed apricot juice (made with dried apricot) were told to be drunken until 2 h before colonoscopy. Receives: Drug: Senna and stewed apricot juice |
| senna alone group | Active comparator | 60 patients received 250 ml of Senna solution (containing 500 mg sennoside A+B calcium) (X-M solution, Yenisehir Pharmaceuticals, Turkey) at 6 PM on the day before colonoscopy, and at 6 AM on the day of the procedure. 1 patient was dropped out due to obstructive sigmoid colon cancer. Receives: Drug: Senna alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of overall colon cleansing
The quality of colon cleansing was evaluated by using the validated Ottawa Bowel Preparation Quality Scale (Table 1). The score was calculated by adding the 0 to 4 ratings for recto-sigmoid, transverse and right colon separately and the 0 to 2 fluid quantity rating. 0, 1 and 2 scores were accepted for adequate preparation while 3 and 4 not, for each colonic segment.
Table 1 Ottawa Bowel Preparation Quality Scale Score Description 0 No fluid
- Able to see mucosa without aspiration
- Able to see mucosa after aspiration
- Able to see mucosa after both washing and aspiration
- Solid stool, incapable of aspiration
Measured: During colonoscopy
Secondary outcomes (1)
The quality of cleansing in the right colon, and patient comfort.
0, 1 and 2 scores were accepted for adequate preparation while 3 and 4 not, for right colonic segment.
Upon arrival at the endoscopy unit,the participants were asked to complete a nurse-administered questionnaire to assess their tolerability and adverse events during preparation. This questionnaire included of 18 questions and was used in similar previous studies specified in references section.
Participant acceptability was assessed as difficulty of finishing ingestion of the regimens.
Participant compliance was defined as success in consuming the total amount of the regimens.
Participants were also asked for willingness to receive the same regimen in the future.
Participants were assessed for safety based on frequency and severity of adverse events nausea, vomiting, abdominal pain, abdominal bloating, weakness,sleep disturbance and anal irritation symptoms rated for absent, mild, moderate and severe.
Measured: During colonoscopy and the day before colonoscopy, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy PreparationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camlıca Erdem Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent Yasar, Camlıca Erdem Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665624
- Sponsor's protocol ID
- HNEAH-2015/KK/04
- Status last verified
- Jan 2016
- First submitted
- 16 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000 Sep;52(3):346-52. doi: 10.1067/mge.2000.108480.
PubMed 10968848Abut E, Guveli H, Yasar B, Bolukbas C, Bolukbas FF, Ince AT, Kendir T, Dalay AR, Kurdas OO. Administration of olive oil followed by a low volume of polyethylene glycol-electrolyte lavage solution improves patient satisfaction with right-side colonic cleansing over administration of the conventional volume of polyethylene glycol-electrolyte lavage solution for colonoscopy preparation. Gastrointest Endosc. 2009 Sep;70(3):515-21. doi: 10.1016/j.gie.2009.01.002. Epub 2009 Jun 24.
PubMed 19555936Berkelhammer C, Ekambaram A, Silva RG. Low-volume oral colonoscopy bowel preparation: sodium phosphate and magnesium citrate. Gastrointest Endosc. 2002 Jul;56(1):89-94. doi: 10.1067/mge.2002.125361.
PubMed 12085041
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Stewed Apricot Juice to Senna Improves the Right-Side and Overall Colon Cleansing Quality for Colonoscopy Preparation
- ClinicalTrials.gov ID
- NCT02665624
- Acronym / sponsor ID
- HNEAH-2015/KK/04
- Conditions
- Colonoscopy Preparation
- Keywords
- Bowel cleansing, Colonoscopy, Stewed apricot juice, Senna
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Camlıca Erdem HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Jan 2016 (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.
Adequate bowel cleansing is essential for optimal colonoscopic examination. However, none of the colonoscopy preparation regimens is safe, efficient and also comfortable. The investigators' aim was to determine whether adding stewed apricot juice to senna increases patient comfort and improves bowel cleansing during colonoscopy preparation.
Detailed description
- Colonoscopy is the current standard method for diagnosing colon cancer and polyps, and also can be used for therapeutic interventions such as polypectomy. Diagnostic accuracy and therapeutic safety of the procedure depends on the quality of the colonic cleansing. Inadequate bowel preparation may result in missed precancerous lesions, longer colonoscopy time, lower cecal intubation rates and increased electrocautery risks. It also causes further costs because the colonoscopy has to be re-scheduled or alternative examinations have to be planned.
- Although polyethylene glycol (PEG) and sodium phosphate (NaP) are the main cleansing solutions in current practice, they tend to be poorly tolerated. The need to intake a large volume of fluid and unpleasant, salty taste of PEG reduce patient compliance. To overcome these limitations, split-dose administration of PEG has been shown effective and more patient-friendly. Unfortunately, PEG solutions have not been available in some countries due to marketing problems, as in Turkey. The potential risks for clinically significant alterations in serum electrolyte levels and hemodynamic instability in patients with renal failure, congestive heart failure, uncontrolled hypertension and ascites limits the usage of NaP. Moreover, European Society of Gastrointestinal Endoscopy (ESGE) suggests that oral NaP can only be advised in selected cases such as patients unable to tolerate other agents or only individuals to be at low risk of NaP-related side-effects. Unfortunately, 20% of patients who consumed PEG or NaP did not have satisfactory bowel cleansing. Because of the limitations of NaP and unavailability of PEG solutions, senna is still the main colonoscopy preparation in some countries..
- The ideal colonoscopy preparation would not only reliably empty the colon, but also not cause any patient discomfort. However, none of the preparations currently meet all of these criteria. Thus, numerous clinical trials have assessed prokinetic and spasmolytic agents, ascorbic acid, olive oil, orange and pineapple juice to attempt to improve the effectiveness and tolerance of colonoscopic preparation regimens. Among these preparations, no additive effect was demonstrated for prokinetic and spasmolytic agents, while authors determined more patient satisfaction and colon cleansing for the rest.
- Senna alkaloids have a direct effect on intestinal mucosa, increasing the colonic motility, enhancing colonic transit, and inhibiting water and electrolyte secretion. Although senna were used effectively alone in the past, they have been replaced by PEG and NaP solutions. Senna have a good-taste and are well-tolerated, inexpensive and have fewer adverse effects, yet, their efficacy is controversial.
- Apricot (Prunus armeniaca L.) has an important place in human nutrition and can be used as fresh or dried. Also, traditionally dried apricots have been used for many years in Mediterranean countries as a remedy for constipation because of their high-fiber content . Furthermore, apricots contain sorbitol (4,6g/100g) which has a laxative effect and used for treating constipation in the elderly.
- Although these fruits are already in our life, to investigators knowledge, there is no study examining the effects of apricot juice for precolonoscopic preparation. Therefore, the investigators conducted this study to establish whether adding stewed apricot juice to senna promotes bowel cleansing as well as patient comfort.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stewed apricot juice + senna group | Active comparator | Drug: Senna and stewed apricot juice68 patients received 250 ml of Senna solution (containing 500 mg sennoside A+B calcium) (X-M solution, Yenisehir Pharmaceuticals, Turkey) at 6 PM on the day before colonoscopy, and at 6 AM on the day of the procedure. Additional one liter of stewed apricot juice (made with dried apricot) were told to be drunken until 2 h before colonoscopy. |
| senna alone group | Active comparator | Drug: Senna alone60 patients received 250 ml of Senna solution (containing 500 mg sennoside A+B calcium) (X-M solution, Yenisehir Pharmaceuticals, Turkey) at 6 PM on the day before colonoscopy, and at 6 AM on the day of the procedure. 1 patient was dropped out due to obstructive sigmoid colon cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients with either sex who were over 18 years of age and referred for elective colonoscopy were included in the study
Key exclusion criteria (6 listed)
- history of renal, cardiac, hepatic and metabolic disease including diabetes mellitus
- history of colonic resection
- hospitalized patients
- pregnancy or breast-feeding
- history of inflammatory bowel disease
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 |
|---|---|---|
| Senna and stewed apricot juiceAlso: X-M solution (300 mg sennoside A+B calcium, Yenisehir Pharmaceuticals), Stewed apricot juice made with dried apricotcomparison of bowel cleansing and patient comfort. | Drug | Stewed apricot juice + senna group |
| Senna aloneAlso: X-M solution (300 mg sennoside A+B calcium, Yenisehir Pharmaceuticals)comparison of bowel cleansing and patient comfort. | Drug | senna alone group |
Primary outcome
The quality of overall colon cleansing
Time frame: During colonoscopy
The quality of colon cleansing was evaluated by using the validated Ottawa Bowel Preparation Quality Scale (Table 1). The score was calculated by adding the 0 to 4 ratings for recto-sigmoid, transverse and right colon separately and the 0 to 2 fluid quantity rating. 0, 1 and 2 scores were accepted for adequate preparation while 3 and 4 not, for each colonic segment. Table 1 Ottawa Bowel Preparation Quality Scale Score Description 0 No fluid 1. Able to see mucosa without aspiration 2. Able to see mucosa after aspiration 3. Able to see mucosa after both washing and aspiration 4. Solid stool, incapable of aspiration
1 secondary outcome
The quality of cleansing in the right colon, and patient comfort.
Time frame: During colonoscopy and the day before colonoscopy, respectively.
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 28 Jan 2016.
- Results publication: PubMed 10968848Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000 Sep;52(3):346-52. doi: 10.1067/mge.2000.108480.
- Results publication: PubMed 19555936Abut E, Guveli H, Yasar B, Bolukbas C, Bolukbas FF, Ince AT, Kendir T, Dalay AR, Kurdas OO. Administration of olive oil followed by a low volume of polyethylene glycol-electrolyte lavage solution improves patient satisfaction with right-side colonic cleansing over administration of the conventional volume of polyethylene glycol-electrolyte lavage solution for colonoscopy preparation. Gastrointest Endosc. 2009 Sep;70(3):515-21. doi: 10.1016/j.gie.2009.01.002. Epub 2009 Jun 24.
- Results publication: PubMed 12085041Berkelhammer C, Ekambaram A, Silva RG. Low-volume oral colonoscopy bowel preparation: sodium phosphate and magnesium citrate. Gastrointest Endosc. 2002 Jul;56(1):89-94. doi: 10.1067/mge.2002.125361.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Senna and stewed apricot juice and Senna alone in people with Colonoscopy Preparation, run by Camlıca Erdem Hospital.
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 6 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The quality of overall colon cleansing (time frame: During colonoscopy). 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 NCT02665624, which also lists 3 linked publications.
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 28 Jan 2016.