- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07931716
Postoperative Energy and Protein Intake Attainment After Elective Laparoscopic Colorectal Cancer Surgery
Development and Validation of a Postoperative Gastrointestinal Dysfunction Assessment Scale for Patients With Colorectal Cancer
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:
- How many patients reach at least 60% of the recommended daily energy intake by day 5 after surgery, or by the day they leave hospital?
- Do patients aged 60 years or older reach the recommended intake less often than younger patients?
Participants will:
- Have all food, drinks and oral nutrition supplements recorded every day, either by a family member using a simple diary or during a daily interview with a dietitian
- Undergo daily assessment of gastrointestinal tolerance using the I-FEED score and the feeding intolerance score
- Have the results of routine blood tests recorded
- Be contacted by telephone about 3 months after surgery to ask about body weight and any further cancer treatment No new treatment is given. All participants receive the usual care of the hospital's ERAS programme.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Huayan Lv, PhD
- Puhelinnumero: +8613967446757
- Sähköposti: lvhuyan2009@163.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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
Kuvaus
Inclusion Criteria:
- Age 18 years or older.
- Elective laparoscopic radical resection for colorectal cancer.
- Alert and able to communicate, read and write, and to complete the study assessments.
- American Society of Anesthesiologists physical status class I, II or III.
- Written informed consent obtained.
Exclusion Criteria:
- Emergency surgery.
- Advanced tumour not amenable to curative resection, treated by palliative resection or palliative stoma only.
- Metastatic disease requiring multi-organ resection.
- Pre-existing chronic gastrointestinal dysfunction that could confound assessment, including inflammatory bowel disease, short bowel syndrome and chronic intestinal obstruction.
- Cognitive impairment or psychiatric disorder precluding assessment.
- Severe visual or auditory impairment precluding interview or questionnaire completion.
- Major intraoperative adverse events, including massive haemorrhage or cardiopulmonary failure.
- Transfer to intensive care, self-discharge or loss to follow-up within 72 hours after surgery.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
Patients aged 60 years or older
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. |
|
Patients younger than 60 years
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Proportion of patients reaching at least 60% of the prescribed energy target
Aikaikkuna: Postoperative day 5, or day of discharge if earlier (assessed up to 7 days after surgery)
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Postoperative day 5, or day of discharge if earlier (assessed up to 7 days after surgery)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Daily energy intake as a percentage of the prescribed target, target set at 25 kcal/kg/day
Aikaikkuna: Postoperative day 1 to Postoperative day 7
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Postoperative day 1 to Postoperative day 7
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Daily protein intake as a percentage of the prescribed target, target set at 1.5 g/kg/day
Aikaikkuna: Postoperative day 1 to Postoperative day 7
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Postoperative day 1 to Postoperative day 7
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Time to first oral fluid, first flatus and first bowel movement
Aikaikkuna: From end of surgery until first documented oral fluid, first flatus and first bowel movement, assessed up to 7 days after surgery
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From end of surgery until first documented oral fluid, first flatus and first bowel movement, assessed up to 7 days after surgery
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Time out of bed per postoperative day (hours)
Aikaikkuna: From postoperative day 1, assessed daily up to postoperative day 7
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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. |
From postoperative day 1, assessed daily up to postoperative day 7
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Duration of supplemental or total parenteral nutrition in days
Aikaikkuna: Postoperative day 1 to the day of discharge (assessed up to 30 days after surgery)
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Postoperative day 1 to the day of discharge (assessed up to 30 days after surgery)
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I-FEED(Intake, Feeling nauseated, Emesis, Exam, Duration) score
Aikaikkuna: Postoperative day 1 to Postoperative day 7
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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 |
Postoperative day 1 to Postoperative day 7
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Patient-level and clinician-level barriers to adequate intake
Aikaikkuna: Postoperative day 1 to Postoperative day 7
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Postoperative day 1 to Postoperative day 7
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Postoperative serum albumin
Aikaikkuna: Postoperative day 1 to Postoperative day 7
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Postoperative day 1 to Postoperative day 7
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Gastrointestinal-2 recovery
Aikaikkuna: Postoperative day 1 to Postoperative day 7
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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. |
Postoperative day 1 to Postoperative day 7
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length of stay
Aikaikkuna: Postoperative day 1 to the day of discharge (assessed up to 30 days after surgery)
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Postoperative day 1 to the day of discharge (assessed up to 30 days after surgery)
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30-day complications and readmission
Aikaikkuna: Postoperative day 1 to Postoperative day 30 (assessed up to 30 days after surgery)
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Postoperative day 1 to Postoperative day 30 (assessed up to 30 days after surgery)
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Interval from surgery to initiation of the first postoperative anti-tumour therapy
Aikaikkuna: 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)
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Telephone follow-up at 3 months after surgery with a 2-week window |
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)
|
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percentage of body weight lost at 3 months
Aikaikkuna: From admission to 3 months after surgery (assessed up to 14 weeks after surgery)
|
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. |
From admission to 3 months after surgery (assessed up to 14 weeks after surgery)
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2026-0836-01
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
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