Recruiting

Low-Residue Diet

Sponsor:

Northwell Health

Code:

NCT07083076

Conditions

Colon Resection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Short term (10 day) low residue diet restriction

6 week low residue diet restriction

Study Details

Brief summary:

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.

Conditions

Colon Resection

Study ID

NCT07083076

Start date

Sep 19, 2025

Status verified date

Jul, 2025

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

222 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Short term (10 day) low residue diet restriction

Patients will have an unrestricted diet (as opposed to a low residue diet restriction) 10 days after surgery.

6 week low residue diet restriction

Patients will be restricted to a low residue diet for 6 weeks after surgery. After this period, their diet will be unrestricted.

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 and Locations

Central contacts

Andrea Zimmern, MD

516-730-2100azimmern@northwell.edu

Russell J Hollis, MD

rhollis1@northwell.edu

Locations

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Andrea Zimmern, MD

(516) 730-2100azimmern@northwell.edu

Russell Hollis, MD

rhollis1@northwell.edu

Long Island Jewish Hospital

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Andrea Zimmern, MD

(516) 730-2100azimmern@northwell.edu

Russell Hollis, MD

rhollis1@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Sep 24, 2025

Last verified

Jul, 2025

Keywords

  • postoperative diet
  • low residue diet
  • colon resection with anastomosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-09-24.