Adding Stewed Apricot Juice to Senna Improves the Right-Side and Overall Colon Cleansing Quality for Colonoscopy Preparation

NCT02665624 | Completed Phase 4 DMC

• 1 other identifier: HNEAH-2015/KK/04
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief 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 colonoscopy preparation.

Conditions

Colonoscopy Preparation

Keywords

Bowel cleansing; Colonoscopy; Stewed apricot juice; Senna

Outcome Measures

Primary Outcomes (1)

• 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

  During colonoscopy

Secondary Outcomes (1)

• The quality of cleansing in the right colon, and patient comfort.

  During colonoscopy and the day before colonoscopy, respectively.

Study Arms (2)

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.

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.

Drug: Senna alone

Interventions

Senna and stewed apricot juice DRUG

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

Stewed apricot juice + senna group

Senna alone DRUG

comparison of bowel cleansing and patient comfort.

Also known as: X-M solution (300 mg sennoside A+B calcium, Yenisehir Pharmaceuticals)

senna alone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with either sex who were over 18 years of age and referred for elective colonoscopy were included in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Camlıca Erdem Hospital: lead

Related Publications (3)

• 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.

  PMID: 10968848 RESULT

• Abut 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.

  PMID: 19555936 RESULT

• Berkelhammer 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.

  PMID: 12085041 RESULT

MeSH Terms

Interventions

Sennosides

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 16, 2016
• First Posted: January 28, 2016
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share