An interventional study of Short term (10 day) low residue diet restriction and 6 week low residue diet restriction in Colon Resection, sponsored by Northwell Health. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Northwell Health · Not applicable, Interventional, and Treatment
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.
Patients who undergo colon resection surgery are often instructed to adhere to a low residue (low insoluble fiber) diet for at least the first 1-2 weeks after surgery. This approach is based on limited previous literature that associates stool burden in the first three to seven days and the risk of leakage from the new connection in the colon (anastomotic leakage). However, there is no clear consensus on how long this low residue diet should last, and low residue diets can negatively affect bowel function-related quality of life. The investigators hypothesize that resuming an unrestricted diet at an earlier time point (10 days) after surgery will improve bowel function-related quality of life without increasing the risk of leakage or other complications compared to a longer time point (6 weeks). Both time points are within the scope of practice, but many surgeons opt for the longer time point. To answer our hypothesis, the investigators plan to use validated survey instruments pre- and postoperatively (at within 2 weeks preoperatively then 1 week, 3 week, 6 week, and 3 months after the surgery) to assess patient's bowel function and health care-related quality of life. Patients will be consented preoperatively and randomized after their surgeries, no later than the day of discharge from the hospital. The participants will take a survey before surgery then have their surgery as the participants normally would. The participants will also have their post-surgery hospital care as normal and before discharge will be instructed on which diet plan the participants must follow (either 10 days or 6 weeks of low residue diet). Patients who have postoperative issues while in the hospital will be excluded, as the participants usually have different postoperative diet recommendations outside of the typical post-surgical pathway. Other than the surveys and different diet instructions, nothing else will change about their post-surgical care. The results of the surveys for each group will be evaluated in several ways. Summary statistics will be obtained to characterize both the intervention and control group. In addition, the pre and post-surgical results will be compared. Other information will be collected, such as demographic information and complication rate, that will be used to compare both groups as well. These results and the subsequent analysis will address our hypothesis and allow us to either recommend a 10-day period of low residue diet or confirm that the 6-week period is safer.
Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 day low residue diet restriction after surgery
Other: Short term (10 day) low residue diet restriction
Usual care arm
Other: 6 week low residue diet restriction
Patients will have an unrestricted diet (as opposed to a low residue diet restriction) 10 days after surgery.
Patients will be restricted to a low residue diet for 6 weeks after surgery. After this period, their diet will be unrestricted.
Return to baseline bowel function (Postoperative Low Anterior Resection Syndrome Score - Preoperative Low Anterior Resection Syndrome Score <=5)
Return to baseline bowel function is defined by comparing the preoperative LARS score (range 0-42) to postoperative LARS score (range 0-42). Return to baseline is defined as a difference equal to or less than 5 when subtracting the postoperative score by the preoperative score.
Time frame: Preoperative to 3 months postoperative
Bowel Function Related Quality of Life
This is a single question survey asking patients about the impact their bowel function has on their quality of life. These answers will be accumulated and compared across both groups. From better to worse, the answers are: A) not at all, B) very little, C) somewhat, D) a lot.
Time frame: preoperative to 3 months postoperative
Health Care Related Quality of Life
This outcome measure is based on 36-Item Short Form Survey Instrument (SF-36) scores which will be averaged, separated in its components, and compared across groups. Each component is scored from 0 - 100 based on responses from the participants, with 100 being the best possible score.
Time frame: preoperative to 3 months postoperative
Complication Rate
Complications, if any occur, will be recorded for each group and incidence of complications will be compared across groups.
Time frame: Preoperative to 2 years postoperative
Plan to share: No — We do not intend to share IPD with other researchers. Data deidentified through REDCap may be shared upon publication of results if requested by the journal and in compliance with IRB requirements.
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