Regular Diet Versus Extended Low Residue After Colon Surgery

Northwell Health

Status: Enrolling

Conditions: Colon Resection

Treatments: Other: Short term (10 day) low residue diet restriction; Other: 6 week low residue diet restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT07083076

24-0448

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 222 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

10 day low residue diet restriction after surgery

Experimental group

Description:

10 day low residue diet restriction after surgery

Treatment:

Other: Short term (10 day) low residue diet restriction

6 week low residue diet restriction after surgery

Other group

Description:

Usual care arm

Treatment:

Other: 6 week low residue diet restriction