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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 (PEGOP)

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ClinicalTrials.gov Identifier: NCT01887158
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Alessandro Mussetto, Ospedale Santa Maria delle Croci

Brief 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.

Condition or disease Intervention/treatment Phase
Intestinal Cancer Drug: Polyethylene glycol Drug: Bisacodyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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.
Study Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: bisacodyl plus 2-Liter Polyethylene glycol
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.
Drug: Polyethylene glycol
Drug: Bisacodyl
Active Comparator: 4-Liter Polyethylene glycol
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.
Drug: Polyethylene glycol



Primary Outcome Measures :
  1. quality of bowel preparation rated according to a modified Ottawa bowel preparation scale [ Time Frame: about 2 weeks after the randomization ]

Secondary Outcome Measures :
  1. 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 ]

    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)


  2. safety (adverse event rate) [ Time Frame: participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization ]
    Safety will be evaluated through reported adverse events, physical examination and vital signs

  3. Lesion detection (type and lesion detection rate/patient) [ Time Frame: about 2 weeks from the randomization ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887158


Locations
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Italy
Alessandro Mussetto
Ravenna, RA, Italy, 48100
Ospedale S.Maria delle Croci
Ravenna, RA, Italy, 48100
Sponsors and Collaborators
Ospedale Santa Maria delle Croci

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alessandro Mussetto, MD, Ospedale Santa Maria delle Croci
ClinicalTrials.gov Identifier: NCT01887158     History of Changes
Other Study ID Numbers: PEGOP0613
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives