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

Intestinal Cancer Clinical Trial

— PEGOP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887158
• Other study ID #: PEGOP0613
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2013
• Last updated: June 15, 2014
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Ospedale Santa Maria delle Croci
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Outpatients

2. =18 yrs old,

3. Prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy

Exclusion Criteria:

1. Inpatients

2. Emergency Colonoscopy

3. Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant

4. Pregnant and/or lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intestinal Cancer

Intervention

Drug:
• Polyethylene glycol

• Bisacodyl

Locations

Country	Name	City	State
Italy	Alessandro Mussetto	Ravenna	RA
Italy	Ospedale S.Maria delle Croci	Ravenna	RA

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Maria delle Croci

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of bowel preparation rated according to a modified Ottawa bowel preparation scale		about 2 weeks after the randomization	Yes
Secondary	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)	participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization	Yes
Secondary	safety (adverse event rate)	Safety will be evaluated through reported adverse events, physical examination and vital signs	participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization	Yes
Secondary	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.	about 2 weeks from the randomization	No