Comparing Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHitit University

About this trial

Colonoscopy Preparation: Comparing Sennoside A+B and PM/Ca

Colonoscopy is a test used to examine the inside of the bowel. Proper bowel preparation is crucial because it helps doctors get a clear view during the procedure.

What is Sennoside A+B? Sennoside A+B is a type of laxative made from the senna plant. It works by stimulating the bowel to move and reducing the absorption of water, making it easier to pass stools. Research has shown that high doses of sennoside A+B can be effective for bowel preparation.

Sennoside A+B vs. PEG:

Some studies have found that sennoside A+B is more effective than PEG, another laxative, but can cause more abdominal pain. Other studies have found no significant difference in effectiveness between the two.

What is Picosulfate/Magnesium Oxide/Citric Acid (PM/Ca)? PM/Ca is a combination of sodium picosulfate, magnesium oxide, and citric acid. Sodium picosulfate stimulates bowel movements, while magnesium oxide and citric acid help increase water in the bowel, making it easier to pass stools.

PM/Ca vs. PEG:

Research has shown that PM/Ca is as effective as PEG for bowel preparation. Patients using PM/Ca generally tolerate the preparation process better than those using PEG.

Conclusion:

While PEG is the preferred option according to guidelines, its high cost can make it less accessible in some places. In this study, we aim to compare the effectiveness and patient tolerance of Sennoside A+B and PM/Ca since no direct comparison between these two preparations has been made before.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-80 years scheduled for elective outpatient colonoscopy.

Ability to provide informed consent.

Disqualifiers

History of intra-abdominal surgery.

Chronic kidney failure.

Congestive heart failure.

Chronic liver failure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sennosid A+B

    Drug

    Bowel Preparation

  • Sodium Picosulfate/Magnesium Oxide/Citric Acid

    Drug

    Bowel Preparation

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: "Sennoside A+B Group" for bowel preparation.Active comparator 1 intervention
Group B: "PM/Ca Group" for bowel preparation.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sennosid A+B versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation: A Prospective Randomized Observer-Blinded Study

Effectiveness of bowel preparation using the Boston Bowel Preparation Scale (BBPS). The BBPS is a standardized 9-point assessment scale for the colon. The structure of the colon is divided into its three segments: right colon, transverse colon, and left colon. Each segment is classified from 0 to 3 depending on the degree of soiling. The sum total of the three segments represents the degree of soiling, so that a total ≤ 5 points shows poor bowel preparation, while 6-7 shows good bowel preparation, and ≥ 8 very good bowel preparation. The investigators will consider patients with a score of 6 or higher as successful.

Time frame
4 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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