Regular Diet Versus Extended Low Residue After Colon Surgery

NCT07083076 | Recruiting

• 1 other identifier: 24-0448
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Colon Resection

Keywords

postoperative diet; low residue diet; colon resection with anastomosis

Outcome Measures

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.

  Preoperative to 3 months postoperative

Secondary Outcomes (2)

• Bowel Function Related Quality of Life

  preoperative to 3 months postoperative

• Health Care Related Quality of Life

  preoperative to 3 months postoperative

Other Outcomes (1)

• Complication Rate

  Preoperative to 2 years postoperative

Study Arms (2)

10 day low residue diet restriction after surgery

EXPERIMENTAL

10 day low residue diet restriction after surgery

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

6 week low residue diet restriction after surgery

OTHER

Usual care arm

Other: 6 week low residue diet restriction

Interventions

Short term (10 day) low residue diet restriction OTHER

Patients will have an unrestricted diet (as opposed to a low residue diet restriction) 10 days after surgery.

10 day low residue diet restriction after surgery

6 week low residue diet restriction OTHER

Patients will be restricted to a low residue diet for 6 weeks after surgery. After this period, their diet will be unrestricted.

6 week low residue diet restriction after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who have elective colon resection with anastomosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Long Island Jewish Hospital

New Hyde Park, New York, 11040, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 35565456 BACKGROUND

• Lau 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.

  PMID: 25203881 BACKGROUND

• Vanhauwaert 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.

  PMID: 26567203 BACKGROUND

• Blomquist 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.

  PMID: 6532041 BACKGROUND

• Uden 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.

  PMID: 3180961 BACKGROUND

• Emmertsen 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.

  PMID: 22504191 BACKGROUND

• He 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.

  PMID: 38426539 BACKGROUND

• Brazier 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.

  PMID: 1285753 BACKGROUND

• Wang 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.

  PMID: 36253504 BACKGROUND

• Battersby 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.

  PMID: 26953985 BACKGROUND

Study Officials

• Andrea Zimmern, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Zimmern, MD

CONTACT

516-730-2100; azimmern@northwell.edu

Russell J Hollis, MD

CONTACT

rhollis1@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery Donald and Barbara Zucker School of Medicine at Hofstra/Northwell

Model Details: 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

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)