Colon ResectionNCT07083076
Regular Diet Versus Extended Low Residue After Colon Surgery
A study testing Short term (10 day) low residue diet restriction and 6 week low residue diet restriction in people with Colon Resection, run by Northwell Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Resection
- What is being tested?
- Short term (10 day) low residue diet restriction and 6 week low residue diet restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who have elective colon resection with anastomosis
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russell J Hollis, MD contact
United States2 sites, 2 recruiting
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Andrea Zimmern, MD, (516) 730-2100, azimmern@northwell.edu
Russell Hollis, MD, rhollis1@northwell.edu
- Recruiting
Long Island Jewish Hospital
New Hyde Park, New York, 11040
Andrea Zimmern, MD, (516) 730-2100, azimmern@northwell.edu
Russell Hollis, MD, rhollis1@northwell.edu
About this study
Official title: Early Introduction of Regular Diet Versus Extended Low Residue Restriction After Colon Surgery
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.
Read the detailed 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.
- Conditions
- Colon Resection
- Being tested
- Short term (10 day) low residue diet restriction, 6 week low residue diet restriction
- Keywords
- postoperative diet, low residue diet, colon resection with anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short term (10 day) low residue diet restrictionOther
Patients will have an unrestricted diet (as opposed to a low residue diet restriction) 10 days after surgery.
6 week low residue diet restrictionOther
Patients will be restricted to a low residue diet for 6 weeks after surgery. After this period, their diet will be unrestricted.
| Study group | Role | What they receive |
|---|---|---|
| 10 day low residue diet restriction after surgery | Experimental | 10 day low residue diet restriction after surgery Receives: Other: Short term (10 day) low residue diet restriction |
| 6 week low residue diet restriction after surgery | Other | Usual care arm Receives: Other: 6 week low residue diet restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative to 3 months postoperative
Secondary outcomes (2)
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.
Measured: 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.
Measured: preoperative to 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start19 Sep 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colon ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: 10 day low residue diet resection after colon resection surgery Group B: 6 week low residue diet resection after colon resection surgery Groups are stratified by hospital, side of colon resected, and biological sex
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Zimmern, Northwell Health
- Investigators
- Andrea Zimmern, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083076
- Sponsor's protocol ID
- 24-0448
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kawada K, Wada T, Yamamoto T, Itatani Y, Hida K, Obama K. Correlation between Colon Perfusion and Postoperative Fecal Output through a Transanal Drainage Tube during Laparoscopic Low Anterior Resection. Cancers (Basel). 2022 May 8;14(9):2328. doi: 10.3390/cancers14092328.
PubMed 35565456Lau C, Phillips E, Bresee C, Fleshner P. Early use of low residue diet is superior to clear liquid diet after elective colorectal surgery: a randomized controlled trial. Ann Surg. 2014 Oct;260(4):641-7; discussion 647-9. doi: 10.1097/SLA.0000000000000929.
PubMed 25203881Vanhauwaert E, Matthys C, Verdonck L, De Preter V. Low-residue and low-fiber diets in gastrointestinal disease management. Adv Nutr. 2015 Nov 13;6(6):820-7. doi: 10.3945/an.115.009688. Print 2015 Nov.
PubMed 26567203Blomquist P, Jiborn H, Zederfeldt B. The effect of relative bowel rest on healing of colonic anastomoses. Breaking strength and collagen in the colonic wall following left colon resection and anastomosis in the rat. Acta Chir Scand. 1984;150(8):671-5.
PubMed 6532041Uden P, Blomquist P, Jiborn H, Zederfeldt B. Influence of long-term relative bowel rest on the healing of a left colon anastomosis. Dis Colon Rectum. 1988 Nov;31(11):886-91. doi: 10.1007/BF02554855.
PubMed 3180961Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
PubMed 22504191He S, Zhang J, Wang R, Li L, Sun W, Wang J, Deng Y, Liang W, Dou R. Long-term Changes in Low Anterior Resection Syndrome in Survivors of Rectal Cancer: Longitudinal Follow-up of a Randomized Controlled Trial. Dis Colon Rectum. 2024 Jun 1;67(6):834-840. doi: 10.1097/DCR.0000000000003262. Epub 2024 Mar 1.
PubMed 38426539Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
PubMed 1285753Wang A, Robitaille S, Liberman S, Feldman LS, Fiore JF Jr, Lee L. Does the Low Anterior Resection Syndrome Score Accurately Represent the Impact of Bowel Dysfunction on Health-Related Quality of Life? J Gastrointest Surg. 2023 Jan;27(1):114-121. doi: 10.1007/s11605-022-05481-z. Epub 2022 Oct 17.
PubMed 36253504Battersby NJ, Juul T, Christensen P, Janjua AZ, Branagan G, Emmertsen KJ, Norton C, Hughes R, Laurberg S, Moran BJ; United Kingdom Low Anterior Resection Syndrome Study Group. Predicting the Risk of Bowel-Related Quality-of-Life Impairment After Restorative Resection for Rectal Cancer: A Multicenter Cross-Sectional Study. Dis Colon Rectum. 2016 Apr;59(4):270-80. doi: 10.1097/DCR.0000000000000552.
PubMed 26953985
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Introduction of Regular Diet Versus Extended Low Residue Restriction After Colon Surgery
- ClinicalTrials.gov ID
- NCT07083076
- Acronym / sponsor ID
- 24-0448
- Conditions
- Colon Resection
- Keywords
- postoperative diet, low residue diet, colon resection with anastomosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: 10 day low residue diet resection after colon resection surgery Group B: 6 week low residue diet resection after colon resection surgery Groups are stratified by hospital, side of colon resected, and biological sex
| Arm | Type | Receives |
|---|---|---|
| 10 day low residue diet restriction after surgery | Experimental | Other: Short term (10 day) low residue diet restriction10 day low residue diet restriction after surgery |
| 6 week low residue diet restriction after surgery | Other | Other: 6 week low residue diet restrictionUsual care arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who have elective colon resection with anastomosis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short term (10 day) low residue diet restrictionPatients will have an unrestricted diet (as opposed to a low residue diet restriction) 10 days after surgery. | Other | 10 day low residue diet restriction after surgery |
| 6 week low residue diet restrictionPatients will be restricted to a low residue diet for 6 weeks after surgery. After this period, their diet will be unrestricted. | Other | 6 week low residue diet restriction after surgery |
Primary outcome
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
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.
2 secondary outcomes
Bowel Function Related Quality of Life
Time frame: preoperative to 3 months postoperative
Health Care Related Quality of Life
Time frame: preoperative to 3 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 35565456Kawada K, Wada T, Yamamoto T, Itatani Y, Hida K, Obama K. Correlation between Colon Perfusion and Postoperative Fecal Output through a Transanal Drainage Tube during Laparoscopic Low Anterior Resection. Cancers (Basel). 2022 May 8;14(9):2328. doi: 10.3390/cancers14092328.
- Background: PubMed 25203881Lau C, Phillips E, Bresee C, Fleshner P. Early use of low residue diet is superior to clear liquid diet after elective colorectal surgery: a randomized controlled trial. Ann Surg. 2014 Oct;260(4):641-7; discussion 647-9. doi: 10.1097/SLA.0000000000000929.
- Background: PubMed 26567203Vanhauwaert E, Matthys C, Verdonck L, De Preter V. Low-residue and low-fiber diets in gastrointestinal disease management. Adv Nutr. 2015 Nov 13;6(6):820-7. doi: 10.3945/an.115.009688. Print 2015 Nov.
- Background: PubMed 6532041Blomquist P, Jiborn H, Zederfeldt B. The effect of relative bowel rest on healing of colonic anastomoses. Breaking strength and collagen in the colonic wall following left colon resection and anastomosis in the rat. Acta Chir Scand. 1984;150(8):671-5.
- Background: PubMed 3180961Uden P, Blomquist P, Jiborn H, Zederfeldt B. Influence of long-term relative bowel rest on the healing of a left colon anastomosis. Dis Colon Rectum. 1988 Nov;31(11):886-91. doi: 10.1007/BF02554855.
- Background: PubMed 22504191Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
- Background: PubMed 38426539He S, Zhang J, Wang R, Li L, Sun W, Wang J, Deng Y, Liang W, Dou R. Long-term Changes in Low Anterior Resection Syndrome in Survivors of Rectal Cancer: Longitudinal Follow-up of a Randomized Controlled Trial. Dis Colon Rectum. 2024 Jun 1;67(6):834-840. doi: 10.1097/DCR.0000000000003262. Epub 2024 Mar 1.
- Background: PubMed 1285753Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
- Background: PubMed 36253504Wang A, Robitaille S, Liberman S, Feldman LS, Fiore JF Jr, Lee L. Does the Low Anterior Resection Syndrome Score Accurately Represent the Impact of Bowel Dysfunction on Health-Related Quality of Life? J Gastrointest Surg. 2023 Jan;27(1):114-121. doi: 10.1007/s11605-022-05481-z. Epub 2022 Oct 17.
- Background: PubMed 26953985Battersby NJ, Juul T, Christensen P, Janjua AZ, Branagan G, Emmertsen KJ, Norton C, Hughes R, Laurberg S, Moran BJ; United Kingdom Low Anterior Resection Syndrome Study Group. Predicting the Risk of Bowel-Related Quality-of-Life Impairment After Restorative Resection for Rectal Cancer: A Multicenter Cross-Sectional Study. Dis Colon Rectum. 2016 Apr;59(4):270-80. doi: 10.1097/DCR.0000000000000552.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Russell J Hollis, MD contact
Andrea Zimmern, MD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short term (10 day) low residue diet restriction and 6 week low residue diet restriction in people with Colon Resection, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Zimmern, MD (516-730-2100, azimmern@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083076, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.