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The effects of combined use of linaclotide and polyethylene glycol electrolyte solution in colonoscopy preparation for patients undergoing endoscopic mucosal resection or endoscopic submucosal dissection

The effects of combined use of linaclotide and polyethylene glycol electrolyte solution in colonoscopy preparation for patients undergoing endoscopic mucosal resection or endoscopic submucosal dissection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090039
Enrollment
Unknown
Registered
2024-09-23
Start date
2023-07-07
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Colonoscopy Cleaning

Interventions

Control group:drink 2L PEG the night before the procedure starting at 7 PM, drink 2L PEG at 7Am on the day of the procedure.
Test group1:take 290ug linaclotide at 7AM the day before the procedure, drink 2L PEG the night before the procedure starting at 7 PM, take 290ug linaclotide at 5AM on the day of the procedure, and
Test group2:take 290ug linaclotide at 7AM 2 days before the procedure, take 290ug linaclotide at 7AM the day before the procedure, drink 1L PEG the night before the procedure starting at 7 PM, take

Sponsors

Beijing Shijitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the study include patients undergoing EMR or ESD meet the following criteria: (1) age 18-70 years; (2) were able to comprehend the trial, sign a written informed consent, including consent a screening procedure to determine eligibility; (3) can communicate with the investigators well and follow verbal and written instructions; (4) take test drugs correctly according to the procedure; (5) undergo follow-up in accordance with the protocol.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the study include patients meet one or more following criteria: (1) lack of an indication for full colonoscopy; (2) has a general contraindication to colonoscopy preparation, such as gastrointestinal obstruction, toxic megacolon, acute surgical abdomen including appendicitis, intestinal perforation and acute diverticulitis; (3) has one of the following diseases: electrolyte disturbances, severe diseases of the heart, liver or kidney; (4) history of any colonic surgery; (5) is taking or has taken linalotide, or is allergic to linalotide; (6)pregnant women; (7) lactating women; (8) are participating in other clinical trials or participated in other clinical trials within 60 days.

Design outcomes

Primary

MeasureTime frame
comfort degree;

Secondary

MeasureTime frame
defecation frequency;Boston Bowel Preparation Scale score;caecal intubation rate;colonoscope insertion time and withdrawal time;adenoma detection rate;

Countries

China

Contacts

Public ContactChunmei Guo

Beijing Shijitan Hospital, Capital Medical University

guoguo10086@163.com+86 134 2647 1832

Outcome results

None listed

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