A Phase 4 interventional study of Senna and stewed apricot juice and Senna alone in Colonoscopy Preparation, sponsored by Camlıca Erdem Hospital. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by Camlıca Erdem Hospital · Phase 4 and Interventional
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.
Camlıca Erdem Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Senna and stewed apricot juice
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.
Drug: Senna alone
comparison of bowel cleansing and patient comfort.
Also known as: 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.
Also known as: X-M solution (300 mg sennoside A+B calcium, Yenisehir Pharmaceuticals)
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 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
Time frame: During colonoscopy
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.
Time frame: During colonoscopy and the day before colonoscopy, respectively.
No study locations are listed for this record.
Plan to share: Yes
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Camlıca Erdem Hospital