An observational study in Postoperative Gastrointestinal Dysfunction, Feeding Intolerance and Colorectal Cancer, sponsored by First Affiliated Hospital of Chongqing Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by First Affiliated Hospital of Chongqing Medical University · Observational
The goal of this observational study is to learn how much energy and protein patients actually take by mouth in the days after surgery for colorectal cancer, compared with the amounts recommended by the hospital's enhanced recovery after surgery (ERAS) programme.
The main questions it aims to answer are:
Participants will:
Surgery is the mainstay of curative treatment for colorectal cancer, and early oral intake is a core element of every ERAS pathway. Adherence to the nutrition element is nonetheless the least audited part of the bundle. In a Canadian academic centre, patients on an ERAS pathway consumed approximately 0.54 g/kg/day of protein in the first three postoperative days, with only about 36 percent meeting the protein target; the corresponding figures under conventional care were 0.33 g/kg/day and 22 percent. The 2025 ESPEN surgical nutrition guideline recommends 25 to 30 kcal/kg/day and 1.2 to 1.5 g/kg/day of protein, with supplemental parenteral nutrition when less than 60 percent of target is reached by 48 to 72 hours in high-risk patients, and the 2025 ERAS Society colorectal guideline recommends 25 kcal/kg/day and 1.5 g/kg/day of protein together with routine daily monitoring of intake. No comparable quantification exists for Chinese colorectal ERAS programmes. This study is a single-centre, prospective, observational cohort with consecutive sampling. Adults scheduled for elective laparoscopic radical resection of colorectal cancer are eligible. All patients receive the standard institutional ERAS pathway, including a protocolised postoperative oral intake schedule; no nutritional intervention is assigned by the study, and all enteral or parenteral nutrition are prescribed by the treating team and recorded as observed. Daily intake was assessed using either the 24-hour dietary recall method or the dietary record method (bookkeeping method). The dietary record method (bookkeeping method) was adopted for patients whose family members could cooperate with the recording. For patients unable to complete dietary recording, daily intake was measured by 24-hour recall, supplemented by visual plate-waste estimation and information from nursing and family caregivers. Energy and protein intake were subsequently calculated using the Chinese Food Composition Tables and product labels. Targets are calculated from admission body weight, with adjusted body weight for patients with a body mass index of 28 or above. The primary outcome is the proportion of patients reaching at least 60 percent of the energy target on postoperative day 5 or at discharge. Secondary outcomes cover daily attainment, process indicators such as time to first oral fluid, first flatus and first bowel movement, resumption of oral intake within 24 hours and supplement prescription and consumption, gastrointestinal tolerance measured by the I-FEED and feeding intolerance scores, agreement between an objective intake grading and the original descriptive intake item, structured patient-level and clinician-level barriers, and clinical outcomes including gastrointestinal recovery, length of stay, 30-day complications, postoperative serum albumin, the interval to initiation of the first postoperative anti-tumour therapy and body weight loss at 3 months. A total of 360 consecutive patients will be enrolled and followed. The sample size is determined by the precision required for the primary outcome, which is a single proportion estimated in the whole cohort rather than a between-group comparison. Published ERAS cohorts show mean postoperative intakes well below prescription, with only a minority of patients reaching 60% of energy requirements during the first three postoperative days[4, 10]. The investigators accordingly assumed p = 0.50, the value that maximises variance and therefore yields the most conservative sample size, with a two-sided 95% confidence interval. A permissible error of 5 percentage points requires 384 patients; the protocol enrols 360, which gives a half-width of 5.2 percentage points and was accepted as the operating precision. Recruitment is consecutive and continues until 360 patients have completed the primary assessment, so that post-enrolment exclusions do not erode the final sample. The two age cohorts will not be of equal size. Based on the age distribution of consecutively admitted patients, approximately two thirds are expected to be aged 60 years or older, giving roughly 240 patients in the older cohort and 120 in the younger cohort. A cohort of about 120 patients yields a half-width of approximately 8.9 percentage points for the cohort-specific proportion. With this allocation, the study has 78% power at a two-sided α of 0.05 to detect an absolute difference of 15 percentage points between age cohorts, and 95% power to detect a difference of 20 percentage points. The primary analysis is performed on the whole cohort; the age-stratified comparison is a prespecified secondary analysis and is not powered as a primary endpoint.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 360 is above the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 96 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adults aged 18 years and older scheduled for elective laparoscopic radical resection of colorectal cancer with ASA physical status I-III, able to communicate and complete assessments, who provide written informed consent, will be enrolled. Exclusions include emergency surgery, palliative procedures, multi-organ resection for metastatic disease, pre-existing chronic gastrointestinal dysfunction, cognitive-psychiatric disorders, severe sensory deficits, major intraoperative adverse events, ICU transfer or early loss-to-follow-up within 72 hours post-operatively. Patients with cancelled surgery, conversion to open operation, intra-operatively confirmed unresectable tumour, or consent withdrawal will be excluded from analysis. All subjects receive routine hospital-standard ERAS management; no study-specific interventions are applied
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutive patients aged 60 years or older at enrolment who undergo elective laparoscopic radical resection for colorectal cancer under the institution's standard ERAS pathway. Cohort assignment is based on age at enrolment, a baseline characteristic, and is not determined by any post-operative outcome. Participants are not allocated to a fixed quota; the size of each cohort reflects the age distribution of consecutively enrolled patients. Followed from preoperative baseline to postoperative day 7 or discharge, with telephone follow-up at 90 days.
Consecutive patients younger than 60 years at enrolment who undergo elective laparoscopic radical resection for colorectal cancer under the institution's standard ERAS pathway. Cohort assignment is based on age at enrolment, a baseline characteristic, and is not determined by any post-operative outcome. Participants are not allocated to a fixed quota; the size of each cohort reflects the age distribution of consecutively enrolled patients. Followed from preoperative baseline to postoperative day 7 or discharge, with telephone follow-up at 90 days.
Proportion of patients reaching at least 60% of the prescribed energy target
Time frame: Postoperative day 5, or day of discharge if earlier (assessed up to 7 days after surgery)
Daily energy intake as a percentage of the prescribed target, target set at 25 kcal/kg/day
Time frame: Postoperative day 1 to Postoperative day 7
Daily protein intake as a percentage of the prescribed target, target set at 1.5 g/kg/day
Time frame: Postoperative day 1 to Postoperative day 7
Time to first oral fluid, first flatus and first bowel movement
Time frame: From end of surgery until first documented oral fluid, first flatus and first bowel movement, assessed up to 7 days after surgery
Time out of bed per postoperative day (hours)
Time out of bed was recorded as the total number of hours per postoperative day during which the patient was out of bed, including sitting out of bed, standing and walking.
Time frame: From postoperative day 1, assessed daily up to postoperative day 7
Duration of supplemental or total parenteral nutrition in days
Time frame: Postoperative day 1 to the day of discharge (assessed up to 30 days after surgery)
I-FEED(Intake, Feeling nauseated, Emesis, Exam, Duration) score
The I-FEED is a five-domain composite instrument for postoperative gastrointestinal dysfunction. Intake, feeling nauseated, emesis and abdominal examination are each scored 0, 1 or 3; duration of symptoms is scored 0, 1 or 2. The total score ranges from 0 to 14, with higher scores indicating worse gastrointestinal function
Time frame: Postoperative day 1 to Postoperative day 7
Patient-level and clinician-level barriers to adequate intake
Time frame: Postoperative day 1 to Postoperative day 7
Postoperative serum albumin
Time frame: Postoperative day 1 to Postoperative day 7
Gastrointestinal-2 recovery
GI-2 is a composite endpoint defined as the later of two events: first tolerance of a semi-liquid diet and first passage of a bowel movement after surgery.
Time frame: Postoperative day 1 to Postoperative day 7
length of stay
Time frame: Postoperative day 1 to the day of discharge (assessed up to 30 days after surgery)
30-day complications and readmission
Time frame: Postoperative day 1 to Postoperative day 30 (assessed up to 30 days after surgery)
Interval from surgery to initiation of the first postoperative anti-tumour therapy
Telephone follow-up at 3 months after surgery with a 2-week window
Time frame: From date of surgery to initiation of first postoperative anti-tumour therapy, assessed up to 3 months after surgery(assessed up to 14 weeks after surgery)
percentage of body weight lost at 3 months
Percentage of body weight lost at 3 months after surgery, calculated as (body weight at admission minus body weight at 3 months after surgery) divided by body weight at admission, multiplied by 100. Admission body weight was measured on the ward before surgery and recorded in the medical record. Body weight at 3 months was obtained at the routine postoperative follow-up visit, with a permitted window of 2 weeks either side of the 3-month time point. Where the patient could not attend, weight was obtained by telephone from a household scale or from the local clinic record.
Time frame: From admission to 3 months after surgery (assessed up to 14 weeks after surgery)
No study locations are listed for this record.
Plan to share: No — De-identified individual participant data will be available upon reasonable request to the corresponding author after publication of the primary manuscript. Data access will be subject to approval by the institutional ethics committee and a signed data use agreement.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 4 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Chongqing Medical University