MedTrace Logo

TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

NCT05148494 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-08-27

No results posted yet for this study

Summary

There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy, to facilitate safe, precise and efficient resection of the rectal lesion and potentially adequate closure of the defect. Both Fleet enemas and oral mechanical bowel preparation are considered standard of care in preparation for TES. This single center two arm single blinded randomized controlled trial will compare the effectiveness of Fleet enemas in comparison to Pico Salax oral mechanical bowel preparation in cleansing the rectum as measured by a modified version of the Ottawa Bowel Prep Scale.

Conditions

  • Colorectal Neoplasms
  • Surgery

Interventions

DRUG

Fleet Enema

standard pre-op application, see arm description

DRUG

Pico-Salax

standard pre-op application, see arm description

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Katerina Neumann · NSHA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2026-08-01
Completion
2026-10-01
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148494 on ClinicalTrials.gov