Low-Residue Diet for Colon Resection

Recruiting at 1 trial location

Overseen By Russell J Hollis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Ostomy, Emergency surgery, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

222 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a shorter, 10-day low-residue diet is as effective as a longer, 6-week diet in restoring normal bowel function after elective colon resection surgery. Researchers aim to determine if the shorter diet plan can facilitate a quicker return to normal life without increasing complications. Participants will follow one of these diet plans and share their experiences through surveys over three months. This trial suits adults who have undergone elective colon resection surgery without an ostomy and are following the standard recovery protocol. As an unphased trial, it offers participants the chance to contribute to innovative research that could simplify recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diet protocol is safe for post-surgery patients?

Research has shown that a 10-day low-residue diet is generally safe and easy to follow. Studies have found that shorter diet restrictions, such as 10 days, do not harm bowel function and might even improve adherence. These studies primarily examined the diet's impact on bowel preparation while also assessing safety. No major problems were reported with shorter diet restrictions, suggesting that the 10-day low-residue diet is as safe as longer diets, like the 6-week plan. Overall, evidence indicates that the 10-day diet plan does not increase the risk of complications, making it a potentially safe choice for those undergoing planned colon surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different durations of low-residue diets after colon resection because this approach could simplify patient recovery. Unlike the typical long-term dietary restrictions, a short-term 10-day low-residue diet might offer a quicker transition back to regular foods, potentially enhancing patient comfort and satisfaction. Moreover, understanding whether a shorter diet period is just as effective as the standard 6-week regimen could lead to more personalized and flexible postoperative care. This trial aims to determine if less restrictive diets can maintain the same health outcomes, possibly setting a new standard for recovery after colon surgery.

What evidence suggests that this trial's diet plans could be effective for bowel function after colon resection?

This trial will compare a 10-day low-residue diet restriction with a 6-week low-residue diet restriction after colon surgery. Research has shown that a shorter, 10-day low-fiber diet after colon surgery might improve bowel function without causing additional issues. Studies indicate that when patients begin a less strict diet sooner, it does not negatively affect their bowel preparation. In fact, it appears to increase adherence to the plan. Some research also suggests that shorter diet restrictions are as effective as longer ones in preparing the bowel. This could lead to quicker recovery and improved quality of life after surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrea Zimmern, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for adult patients undergoing elective colon resection with anastomosis. It's not specified who can't join, but typically those with health issues that could interfere with the study or its outcomes would be excluded.

Inclusion Criteria

I am an adult scheduled for elective surgery to remove part of my colon and join the ends.

Exclusion Criteria

Vulnerable populations: fetuses, pregnant women, children, cognitively impaired individuals, hospital employees, students, healthy controls, prisoners, and other institutionalized individuals

I am under 18 years old.

Patients who do not follow the enhanced recovery protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Randomization

Participants undergo colon resection surgery and are randomized to one of the two diet plans

Hospital stay

In-hospital stay

Dietary Intervention

Participants follow either a 10-day or 6-week low residue diet restriction post-surgery

10 days or 6 weeks

Post-surgery follow-up visits

Follow-up

Participants are monitored for bowel function and quality of life through surveys

3 months

Surveys at 1 week, 3 weeks, 6 weeks, and 3 months post-surgery

Long-term Follow-up

Participants are monitored for complications and quality of life

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 6 week low residue diet restriction
• Short term (10 day) low residue diet restriction

Trial Overview The trial compares two diet restrictions after colon surgery: a short-term (10-day) low-residue diet versus a longer (6-week) one. The aim is to see which leads to faster bowel function recovery and better quality of life without increasing complications.

How Is the Trial Designed?

Group I: 6 week low residue diet restriction after surgery Experimental Treatment 1 Intervention

Usual care arm

Group II: 10 day low residue diet restriction after surgery Experimental Treatment 1 Intervention

10 day low residue diet restriction after surgery

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Citations

1. trialx.com trialx.com/clinical-trials/listings/308015/regular-diet-versus-extended-low-residue-after-colon-surgery/

Regular Diet Versus Extended Low Residue After Colon ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6203512/

Impact of diet restriction on bowel preparation for ... In these studies, diet liberalization did not adversely affect bowel preparations and improved patient willingness to repeat the bowel ...

3. withpower.com withpower.com/trial/phase-colon-resection-6-2025-0c574

Low-Residue Diet for Colon Resection 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 ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2018/10120/impact_of_diet_restriction_on_bowel_preparation.34.aspx

Impact of diet restriction on bowel preparation for... Surprisingly, the compliance of diet restriction was very low (27.8%) in this study. This rate of compliance is significantly lower than reported compliance ...

5. e-ce.org e-ce.org/upload/pdf/ce-2024-061.pdf

day low-residue diet in achieving adequate bowel cleansing Conclusions: The efficacy of 1-day and multiple-day LRD is comparable in achieving satisfactory bowel preparation, highlighting their similar impact on the ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510718328268

The association among diet, dietary fiber, and bowel ... Only 17% and 77% of patients complied with diet restrictions 2 and 1 day(s) before colonoscopy, respectively. We found no association between foods consumed 2 ...