10-day versus 6-week low-residue diet after colon resection with an anastomosis
Early Introduction of Regular Diet Versus Extended Low Residue Restriction After Colon Surgery
NA · Northwell Health · NCT07083076
This study will test whether returning to a regular diet after 10 days instead of staying on a low-residue diet for 6 weeks helps people recover bowel function faster after elective colon resection with an anastomosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health (other) |
| Locations | 2 sites (Manhasset, New York and 1 other locations) |
| Trial ID | NCT07083076 on ClinicalTrials.gov |
What this trial studies
Adults having elective colon resection with an anastomosis are randomized after surgery to either a 10-day or a 6-week low-residue diet restriction. Participants complete validated surveys on bowel function and health-related quality of life before surgery and at 1 week, 3 weeks, 6 weeks, and 3 months after surgery. The trial tracks time to return of normal bowel function and compares complication rates, including anastomotic leakage, between the two groups. Patients with ostomies, emergency surgeries, or those not following the enhanced recovery protocol are excluded, and enrollment and follow-up occur at two Northwell Health hospitals in New York.
Who should consider this trial
Good fit: Adults undergoing elective colon resection with an anastomosis who will follow the standard enhanced recovery postoperative protocol and can attend follow-up at the study sites are eligible.
Not a fit: Patients who have an ostomy, emergency surgery, cannot follow the enhanced recovery protocol, are under 18, or belong to excluded vulnerable groups are unlikely to benefit from or be eligible for this comparison.
Why it matters
Potential benefit: If successful, patients could return to normal eating and bowel habits sooner and have better bowel-related quality of life without an increased risk of complications.
How similar studies have performed: Prior literature linking early stool burden to anastomotic risk is limited and variable, and the direct comparison of a 10-day versus 6-week low-residue period is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients who have elective colon resection with anastomosis Exclusion Criteria: * Patients who have an ostomy as part of their surgery * Patients who undergo emergency surgery * Patients who do not follow the enhanced recovery protocol (the standard postoperative protocol for patients undergoing elective colon resection) * Patients less than 18 years of age * Vulnerable populations: fetuses, pregnant women, children, cognitively impaired, hospital employees, students, healthy controls, prisoners, and other institutionalized individuals
Where this trial is running
Manhasset, New York and 1 other locations
- North Shore University Hospital — Manhasset, New York, United States (RECRUITING)
- Long Island Jewish Hospital — New Hyde Park, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Andrea Zimmern, MD — Northwell Health
- Study coordinator: Andrea Zimmern, MD
- Email: azimmern@northwell.edu
- Phone: 516-730-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colon Resection, postoperative diet, low residue diet, colon resection with anastomosis