Regular Diet Versus Extended Low Residue After Colon Surgery
Part of paid clinical trials in Manhasset, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT07083076
- Status
- Recruiting
Conditions
- Colon Resection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Short term (10 day) low residue diet restriction — OTHERPatients will have an unrestricted diet (as opposed to a low residue diet restriction) 10 days after surgery.
- 6 week low residue diet restriction — OTHERPatients will be restricted to a low residue diet for 6 weeks after surgery. After this period, their diet will be unrestricted.
Study Details
The goal of this clinical trial is to learn if a 10 day low-residue diet restriction is better for bowel function and quality of life without increasing complications compared to a 6 week low-residue diet restriction after elective colon resection surgery. The main questions it aims to answer are: Does a shorter time period of low residue restriction result in a faster return to normal bowel function? Are there any differences in complication rate between a 10 day low-residue diet restriction compared to a 6 week low-residue diet restriction? Participants will be randomized to one of the two diet plans and will be asked to answer surveys about their bowel function and health care related quality of life at various time points for up to 3 months.
Key Dates
- Start date
- Sep 19, 2025
- Status verified
- Jul 2025
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2028
Study Design
- Enrollment
- 222 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 10 day low residue diet restriction after surgery10 day low residue diet restriction after surgery
- Other: 6 week low residue diet restriction after surgeryUsual care arm
Primary Outcome Measure
Return to baseline bowel function (Postoperative Low Anterior Resection Syndrome Score - Preoperative Low Anterior Resection Syndrome Score <=5) [ Time Frame: Preoperative to 3 months postoperative ]
Central Contacts
- Andrea Zimmern, MD516-730-2100
- Russell J Hollis, MD
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | Russell Hollis, MD |
| Long Island Jewish Hospital | New Hyde Park | New York | 11040 | Russell Hollis, MD |