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 — OTHER
    Patients will have an unrestricted diet (as opposed to a low residue diet restriction) 10 days after surgery.
  • 6 week low residue diet restriction — OTHER
    Patients 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 surgery
    10 day low residue diet restriction after surgery
  • Other: 6 week low residue diet restriction after surgery
    Usual 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

Locations (2)

FacilityCityStateZIPSite coordinators
North Shore University HospitalManhassetNew York11030
Andrea Zimmern, MD
(516) 730-2100
Russell Hollis, MD
Long Island Jewish HospitalNew Hyde ParkNew York11040
Andrea Zimmern, MD
(516) 730-2100
Russell Hollis, MD

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