ColorectalNCT07540845
Regular Diet After Colorectal Surgery
A study testing Regular Diet Post-Operatively and Historical Cohort: Low-Fiber Diet in people with Colorectal and Diet Habits, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this pilot study is to assess the safety and feasibility of regular diet after surgical removal of the colon. The study will enroll patients preoperatively, prior to colon surgery, and will follow participants for up to 30 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal, Diet Habits, Surgery
- What is being tested?
- Regular Diet Post-Operatively and Historical Cohort: Low-Fiber Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 31 Jan 2027
- 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
- Male or female ≥ 18 years of age
- Scheduled to undergo colorectal resection
Who cannot join
- Patients with bowel obstructions
- Patients below the age of 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine-Section of Colon and Rectal Surgery
New York, New York, 10021
KM Muktasid, 6469622270, kmm4010@med.cornell.edu
Yasmeen Chahal, MD, 6469622270
About this study
Official title: Impact of Postoperative Regular Diet on Colorectal Outcomes and Patient Quality of Life
The goal of this pilot study is to assess the safety and feasibility of regular diet after surgical removal of the colon. The study will enroll patients preoperatively, prior to colon surgery, and will follow participants for up to 30 days. The study hypothesizes that simplifying nutritional recommendations is safe and may improve quality of life.
Read the detailed description
This pilot study aims to establish the safety of a return to a regular diet after surgery. Patients scheduled to undergo removal of a piece of their colon will be recruited before surgery and placed on a regular diet after surgery. Participants in this trial will be compared with previous patients who have undergone a similar surgery but were educated on and prescribed a low-fiber diet after surgery. Measures relating to morbidity and 30-day readmission rate will be collected prospectively. Surgical complications will also be collected. Participants will complete surveys about anxiety and quality of life at various time points in the study.
The study will track the healthcare resources needed by participants during this study through a number of metrics, such as visits, phone calls, and messaging.
The overarching goals of this study are to determine if resuming a regular diet after surgery is safe, if it impacts quality of life, and whether it increases how often patients need to engage with the healthcare system. The study will also explore associations with patient anxiety and strain on the care team in the form of communications related to diet.
- Conditions
- Colorectal, Diet Habits, Surgery, Post-operative Care
- Being tested
- Regular Diet Post-Operatively, Historical Cohort: Low-Fiber Diet
- Keywords
- diet after surgery, nutrition counseling
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Diet Post-OperativelyOther
Participants will be advised to assume their regular diet post-operatively.
Historical Cohort: Low-Fiber DietOther
Patients who were educated on and prescribed a low-fiber diet postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Regular Diet | Experimental | Not described Receives: Other: Regular Diet Post-Operatively |
| Historical Control | Other | This comparator arm consists of information about the safety of patients treated in the past, Receives: Other: Historical Cohort: Low-Fiber Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of 30-day readmissions
Measured: 30 Days post-operative
Surgery related morbidity
Measured: 30 Days Post-Operatively
Secondary outcomes (3)
Percent of participants who complete the study (Feasibility)
If more than >70% subject complete the study, it will have been considered feasible.
Measured: 30 Days Post-Operatively
Number of participants who drop out of the study
Withdrawal by Post-Op Day 30
Measured: 30 Days Post-Operatively
Number of participants removed from the study due to clinical determination
Measured: 30 Days Post-Operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start13 May 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColorectalStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehraneh Jafari, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540845
- Sponsor's protocol ID
- 25-08029170
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postoperative Regular Diet on Colorectal Outcomes and Patient Quality of Life
- ClinicalTrials.gov ID
- NCT07540845
- Acronym / sponsor ID
- 25-08029170
- Conditions
- Colorectal, Diet Habits, Surgery, Post-operative Care
- Keywords
- diet after surgery, nutrition counseling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Apr 2026 (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 pilot study is to assess the safety and feasibility of regular diet after surgical removal of the colon. The study will enroll patients preoperatively, prior to colon surgery, and will follow participants for up to 30 days. The study hypothesizes that simplifying nutritional recommendations is safe and may improve quality of life.
Detailed description
This pilot study aims to establish the safety of a return to a regular diet after surgery. Patients scheduled to undergo removal of a piece of their colon will be recruited before surgery and placed on a regular diet after surgery. Participants in this trial will be compared with previous patients who have undergone a similar surgery but were educated on and prescribed a low-fiber diet after surgery. Measures relating to morbidity and 30-day readmission rate will be collected prospectively. Surgical complications will also be collected. Participants will complete surveys about anxiety and quality of life at various time points in the study.
The study will track the healthcare resources needed by participants during this study through a number of metrics, such as visits, phone calls, and messaging.
The overarching goals of this study are to determine if resuming a regular diet after surgery is safe, if it impacts quality of life, and whether it increases how often patients need to engage with the healthcare system. The study will also explore associations with patient anxiety and strain on the care team in the form of communications related to diet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Diet | Experimental | Other: Regular Diet Post-Operatively |
| Historical Control | Other | Other: Historical Cohort: Low-Fiber DietThis comparator arm consists of information about the safety of patients treated in the past, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female ≥ 18 years of age
- Scheduled to undergo colorectal resection
Key exclusion criteria (2 listed)
- Patients with bowel obstructions
- Patients below the age of 18
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 |
|---|---|---|
| Regular Diet Post-OperativelyParticipants will be advised to assume their regular diet post-operatively. | Other | Regular Diet |
| Historical Cohort: Low-Fiber DietPatients who were educated on and prescribed a low-fiber diet postoperatively. | Other | Historical Control |
Primary outcome
Number of 30-day readmissions
Time frame: 30 Days post-operative
Surgery related morbidity
Time frame: 30 Days Post-Operatively
3 secondary outcomes
Percent of participants who complete the study (Feasibility)
Time frame: 30 Days Post-Operatively
Number of participants who drop out of the study
Time frame: 30 Days Post-Operatively
Number of participants removed from the study due to clinical determination
Time frame: 30 Days Post-Operatively
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 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Mehraneh Jafari, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Diet Post-Operatively and Historical Cohort: Low-Fiber Diet in people with Colorectal and Diet Habits, run by Weill Medical College of Cornell University at 1 site 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 2 inclusion and 2 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 KM Clinical Research Specialist (646-962-2789, kmm4010@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of 30-day readmissions (time frame: 30 Days post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.