Comparison of Bowel Cleansing Regimens for Colonoscopy

NCT06021639 | Completed

• 1 other identifier: Mersin2023
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is a frequently used method in colon cancer screening today. Routine bowel cleansing is performed for colonoscopy. When the guidelines are examined, there are various recommendations regarding colonoscopy preparation regimens and durations. In this study, participants using the same colon cleansing drug before colonoscopy will be compared in terms of colon cleansing of the patient group who had a clear diet in the last 24 hours before the procedure and the patient group who had a low fiber diet.

Conditions

Colonoscopy Preparation

Keywords

Bowel preparation; Colonoscopy; Sennoside A+B calcium

Outcome Measures

Primary Outcomes (1)

• Cleaning during colonoscopy

  The quality of cleaning for each segment of the colon was rated ac- cording to the Boston Bowel Preparation Scale (BBPS) as follows: Score 0 (mucosa not visible due to solid stool, or thick liquid stool cannot be cleared); Score 1 (areas of the colon segment not seen well due to staining, resid- ual stool, and/or opaque liquid); Score 2 (minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa seen well); and Score 3 (en- tire mucosa of the colon segment seen well). The left colon, transverse colon, and right colon segments were scored separately, and then these segment scores were summed for a total BBPS score ranging from 0 to 9. Categorical assessment for each possible total BBPS score: "excellent," 8-9; "good," 6-7; "fair," 5; "poor," 3-4; or "unsatisfactory," 0-2

  During the colonoscopy procedure

Study Arms (2)

Low fiber diet group

EXPERIMENTAL

250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. He/she will consume low fiber food in the last 24 hours.

Dietary Supplement: The last 24 hours will consume low fiber food.

Clear diet group

NO INTERVENTION

250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. The last 24 hours will consume clear diet.

Interventions

The last 24 hours will consume low fiber food. DIETARY_SUPPLEMENT

White bread, white rice, plain pasta or noodles, cereals not containing more than 1 gram of fiber per serving., canned or cooked skinless and seedless fruit, skinless and seedless raw fruit, pulp-free or low-fiber fruit or vegetable broth, seedless, seedless, skinless, such as canned or well-cooked carrots, string beans or peppers vegetables, tender red meat, poultry and fish, eggs, no more than two tablespoons per day, soft (creamy) peanut butter, milk, yogurt or plain cheese, salad dressings without oils or nuts, desserts without nuts.

Low fiber diet group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years and older
• Patients undergoing colonoscopy for colorectal cancer screening, or patients with nonspecific gastrointestinal symptoms

You may not qualify if:

• Patients with a serious medical condition such as severe heart
• Kidney or metabolic disease
• Psychiatric disease not complying with the recommended regimen
• Patients with a history of colon resection for any reason
• Patients with suspected intestinal obstruction or ileus
• Patients undergoing emergency colonoscopy
• Patients who did not accept the informed consent form.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Hilmi Bozkurt

Mersin, 33343, Turkey (Türkiye)

Location

Related Publications (6)

• Lorenzo-Zuniga V, Moreno-de-Vega V, Boix J. [Preparation for colonoscopy: types of scales and cleaning products]. Rev Esp Enferm Dig. 2012 Aug;104(8):426-31. doi: 10.4321/s1130-01082012000800006. Spanish.

  PMID: 23039803 BACKGROUND

• Ozer Etik D, Suna N, Gunduz C, Bostan A, Ozdemir A, Gurel BY, Yenisekerci E, Boyacioglu AS. Can a 1-day clear liquid diet with a split -dose polyethylene glycol overcome conventional practice patterns during the preparation for screening colonoscopy? Turk J Gastroenterol. 2019 Sep;30(9):817-825. doi: 10.5152/tjg.2019.19071.

  PMID: 31258137 BACKGROUND

• Labianca R, Merelli B. Screening and diagnosis for colorectal cancer: present and future. Tumori. 2010 Nov-Dec;96(6):889-901.

  PMID: 21388049 BACKGROUND

• Haseman JH, Lemmel GT, Rahmani EY, Rex DK. Failure of colonoscopy to detect colorectal cancer: evaluation of 47 cases in 20 hospitals. Gastrointest Endosc. 1997 Jun;45(6):451-5. doi: 10.1016/s0016-5107(97)70172-x.

  PMID: 9199899 BACKGROUND

• Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.

  PMID: 23335011 BACKGROUND

• Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15.

  PMID: 22104756 BACKGROUND

Study Officials

• Hilmi Bozkurt

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization will be planned 1 to 1 according to the order of application. Randomization will be planned by the endoscopy nurse in the endoscopy unit and will not be known to the endoscopist who will perform the procedure.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Clear diet group (72 patients) 250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. The last 24 hours will consume clear diet. Low fiber diet group (72 patients) 250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. He/she will consume low fiber food in the last 24 hours.

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: November 20, 2023
• Primary Completion: February 3, 2024
• Study Completion: February 18, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (1)