Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 10:18 AM
Study NCT ID:
NCT07470892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Fish Oil PN and Prognosis After Constipation Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D008531', 'term': 'Megacolon'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complication rate', 'timeFrame': 'From postoperative period through 6 months after surgery'}]}, 'conditionsModule': {'conditions': ['Constipation', 'Slow Transit Constipation', 'Megacolon']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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).\n\nThe 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.\n\nThis 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.\n\nThe planned sample size is 306 participants. The findings may help optimize perioperative nutritional support strategies for patients with constipation undergoing surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 75 years.\n2. Meets diagnostic criteria for slow-transit constipation (STC) or megacolon and is scheduled for elective colon surgery.\n3. Nutritional Risk Screening 2002 (NRS2002) score \\>=3.\n4. 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).\n5. Voluntarily participates in the study and provides signed informed consent.\n\nExclusion Criteria:\n\n1. Mental disorders or other conditions that prevent cooperation with treatment or follow-up.\n2. 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.\n3. Contraindications to surgery or parenteral nutrition.\n4. Concurrent enrollment in another study.\n5. No baseline data available before initiation of nutritional support treatment.\n6. Any other condition judged by the investigator to make the participant unsuitable for this study.'}, 'identificationModule': {'nctId': 'NCT07470892', 'acronym': 'FOCP', 'briefTitle': 'Preoperative Fish Oil PN and Prognosis After Constipation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Impact of Preoperative Fish Oil-Containing Parenteral Nutrition on Prognosis in Patients Undergoing Surgery for Constipation: A Prospective, Multicenter, Real-World Study', 'orgStudyIdInfo': {'id': 'YXLL-KY-2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre+Post-op Fish Oil PN Group', 'description': '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.', 'interventionNames': ['Drug: Fish oil-containing total parenteral nutrition (PN)']}, {'label': 'Post-op Only Fish Oil PN Group', 'description': '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.', 'interventionNames': ['Drug: Fish oil-containing total parenteral nutrition (PN)']}], 'interventions': [{'name': 'Fish oil-containing total parenteral nutrition (PN)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Post-op Only Fish Oil PN Group', 'Pre+Post-op Fish Oil PN Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jingbo Chen', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}