Factors Related to a Persistent Inadequate Bowel Preparation for

Status Recruiting

Clinical Trial Summary

Adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. The guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. It has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again. Surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. Therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. The implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. Furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units. Inclusion criteria: Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing. Exclusion criteria: - Emergency regime - Inability to obtain consent - Refusal of the patient Primary end-point: Identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model. The colon cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. Colon cleansing will be judged inadequate in case of a total score <6 or a score <2 even in only one of the colic segments. Secondary end-point: • Assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04693299
Study type	Observational
Source	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact	Lorenzo Fuccio, MD
Phone	+39 3383079255
Email	lorenzofuccio@gmail.com
Status	Recruiting
Phase
Start date	November 1, 2020
Completion date	June 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05512026` - Performance of the Poseidon System for Fluid Management During Water-aided Colonoscopy	N/A
Recruiting	`NCT05322486` - Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases
Completed	`NCT02276768` - Study on Analgesia of GIC-1001 & GIC-1002 on Visceral Pain, Rectal Sensory Threshold Using the Barostat Method	Phase 1
Not yet recruiting	`NCT06271538` - Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome	Phase 4
Not yet recruiting	`NCT05391529` - Patients Decision Making in Choosing Between Colonic Investigation Alternatives
Recruiting	`NCT05709145` - Written Recommendation to Improve Adherence in Poor Bowel Preparation	N/A
Enrolling by invitation	`NCT04765163` - Research on Operating Handle of Colonoscope
Completed	`NCT04112654` - Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection	N/A
Completed	`NCT05540418` - Effect of Lavender Oil Inhalation in Colonoscopy Patients	N/A
Not yet recruiting	`NCT06435377` - Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions
Completed	`NCT04487626` - Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring	N/A
Not yet recruiting	`NCT05836064` - GastroBot: Artificial Intelligence Applied to Bowel Preparation	N/A
Not yet recruiting	`NCT05249335` - Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly	Phase 4
Recruiting	`NCT05249192` - Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection	N/A
Recruiting	`NCT06031051` - Capsule Endoscopy as an Alternative to Colonoscopy	N/A
Completed	`NCT00604422` - Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy — REPREP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms