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Efficacy of simethicone in the treatment of abdominal distension after colonoscopy: a multi-center, single-blinded, randomized controlled study

Efficacy of simethicone in the treatment of abdominal distension after colonoscopy: a multi-center, single-blinded, randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091746
Enrollment
Unknown
Registered
2024-11-01
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal pain and bloating after colonoscopy

Interventions

A:Group taking 30 ml of simethicone before the colonoscopy.
B:Group taking 15 ml of simethicone before the colonoscopy.
C: Group taking 15 ml of simethicone before the colonoscopy and another 15 ml after the examination.

Sponsors

Zhongshan Hospital ( Xiamen ) , Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 70 years; Patients undergoing colonoscopy for colorectal cancer screening or general health check-up; Voluntary participation in the study, with signed written informed consent, good compliance, and willingness to follow up.

Exclusion criteria

Exclusion criteria: 1.Pregnant, breastfeeding women, or women who do not exclude the possibility of pregnancy; 2.Abnormal liver function (total bilirubin, alanine transaminase, or aspartate transaminase = twice the upper limit of normal); 3.Serum creatinine = 1.2 times the upper limit of normal; 4.Individuals allergic to simethicone emulsion or its components; 5.Severe cardiac or pulmonary dysfunction; 6.Suffering from severe gastrointestinal diseases such as colorectal cancer, inflammatory bowel disease, or ischemic bowel disease; 7.Experiencing symptoms such as abdominal pain, bloating, or discomfort prior to the colonoscopy; 8.Patients with a history of intestinal obstruction; 9.Patients with advanced malignant tumors or other severe catabolic diseases, any unstable acute or chronic conditions; 10.Individuals who have undergone abdominal surgery within the past 6 months; 11.Patients found to have intestinal narrowing during the colonoscopy; 12.Difficulty during the colonoscopy (time to reach the cecum exceeding 10 minutes); 13.Cases with known or suspected non-compliance with the study protocol, such as alcoholism, drug dependence, or psychological disorders; 14.Participation in another drug trial within three months prior to the start of the study; 15.Any patients considered by the researchers as unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Bloating, abdominal pain and abdominal discomfort;Duration of postoperative bloating;

Secondary

MeasureTime frame
Boston bowel preparation scale;Cecal intubation time;Cecal intubation rate;Adenoma detection rate;

Countries

China

Contacts

Public ContactDalong Sun

Zhongshan Hospital ( Xiamen ) , Fudan University

sun.dalong@zs-hospital.sh.cn+86 136 5185 9188

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026