TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

Phase 4

Recruiting

• Conditions: Colorectal Neoplasms; Surgery

• Registration Number: NCT05148494
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Inclusion Criteria:<br><br> - undergoing transanal endoscopic surgery at the QEII Health Sciences Center in<br> Halifax by one of the colorectal trained surgeons<br><br>Exclusion Criteria:<br><br> - chronic constipation not well controlled with diet or stool softening agents<br><br> - previous pelvic radiation<br><br> - inflammatory bowel disease<br><br> - repeat transanal surgery for the same lesion<br><br> - patient unable to self-administer enemas<br><br> - patient unable to tolerate either of the 2 bowel preps due to medical reasons<br><br> - age over 75<br><br> - clear diagnosis of congestive heart failure<br><br> - daily use of Lasix or similar loop diuretic<br><br> - chronic steroid use<br><br> - Transanal Endoscopic Surgery combined with another surgical procedure

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of bowel preparation

Secondary Outcome Measures

Name	Time	Method
Validation of the modified version of the Ottawa Bowel Prep Scale;Time spent cleaning operating field;Ability to close the surgical defect;Patient tolerability of preparation;Post-operative complications