Regular Diet Versus Extended Low Residue After Colon Surgery
ConditionColon Resection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients who have elective colon resection with anastomosis
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Short term (10 day) low residue diet restriction
Other interventionPatients will have an unrestricted diet (as opposed to a low residue diet restriction) 10 days after surgery.
6 week low residue diet restriction
Other interventionPatients will be restricted to a low residue diet for 6 weeks after surgery. After this period, their diet will be unrestricted.
Treatment groups
222 Participants
are divided into 2 treatment groupsGroup A: 10 day low residue diet restriction after surgeryExperimental treatment 1 intervention
Group B: 6 week low residue diet restriction after surgeryOther 1 intervention
Trial outcomes
Primary outcomes
1
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 postoperativeSecondary outcomes
1
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 postoperative2
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 postoperativeOther outcomes
1
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 postoperativeSponsors and contacts
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Source ClinicalTrials.gov