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NCT Number: NCT01887158

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

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.

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Key information

Conditions

Intestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alessandro Mussetto, Ravenna, RA, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients
  • ≥18 yrs old,
  • Prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy

Exclusion criteria

  • Inpatients
  • Emergency Colonoscopy
  • Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant
  • Pregnant and/or lactating women

Treatment and study plan

Polyethylene glycol

Drug

Bisacodyl

Drug

Primary outcomes

  1. quality of bowel preparation rated according to a modified Ottawa bowel preparation scale

    Time frame: about 2 weeks after the randomization

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ospedale Santa Maria delle Croci

Other

Registry information

Official study 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.

Acronym: PEGOP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2013
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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