search
Back to results

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)

Primary Purpose

Intestinal Cancer

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Polyethylene glycol
Bisacodyl
Sponsored by
Ospedale Santa Maria delle Croci
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alessandro Mussetto
  • Ospedale S.Maria delle Croci

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

bisacodyl plus 2-Liter Polyethylene glycol

4-Liter Polyethylene glycol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
safety (adverse event rate)
Safety will be evaluated through reported adverse events, physical examination and vital signs
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.

Full Information

First Posted
June 11, 2013
Last Updated
June 15, 2014
Sponsor
Ospedale Santa Maria delle Croci
search

1. Study Identification

Unique Protocol Identification Number
NCT01887158
Brief Title
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
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Santa Maria delle Croci

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bisacodyl plus 2-Liter Polyethylene glycol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
4-Liter Polyethylene glycol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol
Intervention Type
Drug
Intervention Name(s)
Bisacodyl
Primary Outcome Measure Information:
Title
quality of bowel preparation rated according to a modified Ottawa bowel preparation scale
Time Frame
about 2 weeks after the randomization
Secondary Outcome Measure Information:
Title
Tolerability to the preparation (specific questionaire)
Description
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)
Time Frame
participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization
Title
safety (adverse event rate)
Description
Safety will be evaluated through reported adverse events, physical examination and vital signs
Time Frame
participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization
Title
Lesion detection (type and lesion detection rate/patient)
Description
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.
Time Frame
about 2 weeks from the randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alessandro Mussetto
City
Ravenna
State/Province
RA
ZIP/Postal Code
48100
Country
Italy
Facility Name
Ospedale S.Maria delle Croci
City
Ravenna
State/Province
RA
ZIP/Postal Code
48100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25910064
Citation
Mussetto A, Frazzoni L, Paggi S, Dari S, Laterza L, Radaelli F, Hassan C, Triossi O, Fuccio L. Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial. Endoscopy. 2015 Oct;47(10):917-24. doi: 10.1055/s-0034-1391987. Epub 2015 Apr 24.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs