ConstipationFOCPNCT07470892
Preoperative Fish Oil PN and Prognosis After Constipation Surgery
An observational study of Constipation and Slow Transit Constipation, run by Qianfoshan Hospital.
Trial summary
This is a prospective, multicenter, real-world observational study to evaluate the impact of perioperative parenteral nutrition (PN) with fish oil-containing lipid emulsion on outcomes in adult patients with constipation undergoing elective colon surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation, Slow Transit Constipation, Megacolon
- What is being tested?
- Fish oil-containing total parenteral nutrition (PN)
- Type of treatment
- Pill or oral medicine
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Sep 2029
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Adult patients (18-75 years) with slow-transit constipation (STC) or megacolon who meet clinical and diagnostic criteria, are scheduled for elective colon surgery, and have nutritional risk (NRS2002 score >=3). STC is identified based on Rome IV functional constipation criteria with objective evidence of delayed colonic transit and exclusion of outlet obstruction/pelvic floor dyssynergia. Megacolon is diagnosed based on clinical presentation and imaging evidence of colonic dilatation without mechanical obstruction, with exclusion of Hirschsprung disease and other obstructive causes. Participants are enrolled in a prospective multicenter real-world observational study comparing perioperative timing strategies of fish oil-containing parenteral nutrition.
Who may be able to join
- Age 18 to 75 years.
- Meets diagnostic criteria for slow-transit constipation (STC) or megacolon and is scheduled for elective colon surgery.
- Nutritional Risk Screening 2002 (NRS2002) score >=3.
- Receives fish oil-containing parenteral nutrition (PN) for >=3 days preoperatively or initiates PN for the first time postoperatively (according to the study cohort definition).
- Voluntarily participates in the study and provides signed informed consent.
Who cannot join
- Mental disorders or other conditions that prevent cooperation with treatment or follow-up.
- Pregnant or breastfeeding women, women planning pregnancy / in a pre-pregnancy state, or women with a clear intention to become pregnant during the perioperative period or follow-up.
- Contraindications to surgery or parenteral nutrition.
- Concurrent enrollment in another study.
- No baseline data available before initiation of nutritional support treatment.
- Any other condition judged by the investigator to make the participant unsuitable for this study.
About this study
Official title: Impact of Preoperative Fish Oil-Containing Parenteral Nutrition on Prognosis in Patients Undergoing Surgery for Constipation: A Prospective, Multicenter, Real-World Study
This is a prospective, multicenter, real-world observational study to evaluate the impact of perioperative parenteral nutrition (PN) with fish oil-containing lipid emulsion on outcomes in adult patients with constipation undergoing elective colon surgery.
The study will compare two clinical nutrition strategies: (1) PN with fish oil-containing lipid emulsion started before surgery and continued after surgery, and (2) PN with fish oil-containing lipid emulsion started only after surgery. Eligible participants are adults (18-75 years) with slow-transit constipation (STC) or megacolon who are scheduled for elective colon surgery and have nutritional risk (NRS2002 score >=3).
Read more
The primary objective is to compare the incidence of postoperative complications between these two PN timing strategies. Secondary objectives include comparison of perioperative nutritional status, postoperative inflammatory status, prognosis, and safety outcomes.
This study will collect and analyze clinical data, laboratory indicators, perioperative recovery outcomes, follow-up assessments, and safety information in routine clinical practice. Outcomes include postoperative complication rates, changes in nutritional and inflammatory markers, bowel function recovery, length of hospital stay, constipation-related symptoms, quality of life, and adverse events. No experimental intervention will be assigned as part of this observational study.
The planned sample size is 306 participants. The findings may help optimize perioperative nutritional support strategies for patients with constipation undergoing surgery.
- Conditions
- Constipation, Slow Transit Constipation, Megacolon
- Being tested
- Fish oil-containing total parenteral nutrition (PN)
- Medical subject headings
- Constipation, Megacolon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil-containing total parenteral nutrition (PN)Drug
Nutritional support is based on an all-in-one parenteral nutrition (PN) formulation containing omega-3 triglycerides (fish oil, 2%), medium/long-chain lipid emulsion, amino acids, and glucose. In the preoperative observation cohort, participants receive fish oil-containing PN in addition to a normal diet for >=3 days before surgery (duration determined by clinical condition), including PN administration around the preoperative fasting period to maintain energy supply. In the comparison cohort, participants receive a normal diet preoperatively. In both cohorts, PN is initiated on postoperative day 1. Postoperative nutritional management follows the same protocol in both cohorts, with gradual advancement toward energy/protein targets and progressive transition to enteral nutrition/oral nutritional supplements (EN/ONS), with PN tapering and discontinuation when EN/ONS provides adequate energy intake.
| Study group | Role | What they receive |
|---|---|---|
| Pre+Post-op Fish Oil PN Group | Participants who receive parenteral nutrition (PN) with a fish oil-containing lipid emulsion before elective colon surgery (for at least 3 days preoperatively, based on clinical condition) and continue PN after surgery as part of routine clinical care, including perioperative use around the preoperative fasting period to maintain energy supply. Postoperative PN is initiated on postoperative day 1. Receives: Drug: Fish oil-containing total parenteral nutrition (PN) | |
| Post-op Only Fish Oil PN Group | Participants who initiate parenteral nutrition (PN) with a fish oil-containing lipid emulsion only after elective colon surgery as part of routine clinical care. Before surgery, participants receive a normal diet and do not receive the study PN strategy preoperatively. Postoperative PN is initiated on postoperative day 1. Receives: Drug: Fish oil-containing total parenteral nutrition (PN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rate
Measured: From postoperative period through 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingbo Chen, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470892
- Sponsor's protocol ID
- YXLL-KY-2026
- Acronym
- FOCP
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Fish Oil-Containing Parenteral Nutrition on Prognosis in Patients Undergoing Surgery for Constipation: A Prospective, Multicenter, Real-World Study
- ClinicalTrials.gov ID
- NCT07470892
- Acronym / sponsor ID
- FOCP / YXLL-KY-2026
- Conditions
- Constipation, Slow Transit Constipation, Megacolon
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 13 Mar 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.
This is a prospective, multicenter, real-world observational study to evaluate the impact of perioperative parenteral nutrition (PN) with fish oil-containing lipid emulsion on outcomes in adult patients with constipation undergoing elective colon surgery.
The study will compare two clinical nutrition strategies: (1) PN with fish oil-containing lipid emulsion started before surgery and continued after surgery, and (2) PN with fish oil-containing lipid emulsion started only after surgery. Eligible participants are adults (18-75 years) with slow-transit constipation (STC) or megacolon who are scheduled for elective colon surgery and have nutritional risk (NRS2002 score >=3).
The primary objective is to compare the incidence of postoperative complications between these two PN timing strategies. Secondary objectives include comparison of perioperative nutritional status, postoperative inflammatory status, prognosis, and safety outcomes.
This study will collect and analyze clinical data, laboratory indicators, perioperative recovery outcomes, follow-up assessments, and safety information in routine clinical practice. Outcomes include postoperative complication rates, changes in nutritional and inflammatory markers, bowel function recovery, length of hospital stay, constipation-related symptoms, quality of life, and adverse events. No experimental intervention will be assigned as part of this observational study.
The planned sample size is 306 participants. The findings may help optimize perioperative nutritional support strategies for patients with constipation undergoing surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre+Post-op Fish Oil PN Group | – | Drug: Fish oil-containing total parenteral nutrition (PN)Participants who receive parenteral nutrition (PN) with a fish oil-containing lipid emulsion before elective colon surgery (for at least 3 days preoperatively, based on clinical condition) and continue PN after surgery as part of routine clinical care, including perioperative use around the preoperative fasting period to maintain energy supply. Postoperative PN is initiated on postoperative day 1. |
| Post-op Only Fish Oil PN Group | – | Drug: Fish oil-containing total parenteral nutrition (PN)Participants who initiate parenteral nutrition (PN) with a fish oil-containing lipid emulsion only after elective colon surgery as part of routine clinical care. Before surgery, participants receive a normal diet and do not receive the study PN strategy preoperatively. Postoperative PN is initiated on postoperative day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-75 years) with slow-transit constipation (STC) or megacolon who meet clinical and diagnostic criteria, are scheduled for elective colon surgery, and have nutritional risk (NRS2002 score >=3). STC is identified based on Rome IV functional constipation criteria with objective evidence of delayed colonic transit and exclusion of outlet obstruction/pelvic floor dyssynergia. Megacolon is diagnosed based on clinical presentation and imaging evidence of colonic dilatation without mechanical obstruction, with exclusion of Hirschsprung disease and other obstructive causes. Participants are enrolled in a prospective multicenter real-world observational study comparing perioperative timing strategies of fish oil-containing parenteral nutrition.
Key inclusion criteria (5 listed)
- Age 18 to 75 years.
- Meets diagnostic criteria for slow-transit constipation (STC) or megacolon and is scheduled for elective colon surgery.
- Nutritional Risk Screening 2002 (NRS2002) score >=3.
- Receives fish oil-containing parenteral nutrition (PN) for >=3 days preoperatively or initiates PN for the first time postoperatively (according to the study cohort definition).
- Voluntarily participates in the study and provides signed informed consent.
Key exclusion criteria (6 listed)
- Mental disorders or other conditions that prevent cooperation with treatment or follow-up.
- Pregnant or breastfeeding women, women planning pregnancy / in a pre-pregnancy state, or women with a clear intention to become pregnant during the perioperative period or follow-up.
- Contraindications to surgery or parenteral nutrition.
- Concurrent enrollment in another study.
- No baseline data available before initiation of nutritional support treatment.
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 |
|---|---|---|
| Fish oil-containing total parenteral nutrition (PN)Nutritional support is based on an all-in-one parenteral nutrition (PN) formulation containing omega-3 triglycerides (fish oil, 2%), medium/long-chain lipid emulsion, amino acids, and glucose. In the preoperative observation cohort, participants receive fish oil-containing PN in addition to a normal diet for >=3 days before surgery (duration determined by clinical condition), including PN administration around the preoperative fasting period to maintain energy supply. In the comparison cohort, participants receive a normal diet preoperatively. In both cohorts, PN is initiated on postoperative day 1. Postoperative nutritional management follows the same protocol in both cohorts, with gradual advancement toward energy/protein targets and progressive transition to enteral nutrition/oral nutritional supplements (EN/ONS), with PN tapering and discontinuation when EN/ONS provides adequate energy intake. | Drug | Post-op Only Fish Oil PN Group, Pre+Post-op Fish Oil PN Group |
Primary outcome
Postoperative complication rate
Time frame: From postoperative period through 6 months after surgery
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 13 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Slow Transit Constipation, run by Qianfoshan Hospital.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rate (time frame: From postoperative period through 6 months after surgery). 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 13 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.