An observational study in Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Observational
Octogenarian patients with colorectal cancer are a growing population with substantial heterogeneity in frailty, functional reserve, nutritional status, and comorbidity. Chronological age alone does not adequately capture this variation in perioperative risk. Although geriatric assessment has been increasingly incorporated into the care of older patients with cancer, comprehensive geriatric assessment can be difficult to implement routinely in colorectal surgical practice.
The SGA-OCRC study is a prospective, multicenter observational cohort study designed to address this gap. The investigators will evaluate whether a pragmatic simplified geriatric assessment provides prognostic information beyond conventional clinical, laboratory, and tumor-related risk factors in patients aged ≥80 years with non-metastatic, resectable colorectal cancer. The study will develop and internally validate a preoperative prediction model for 90-day major adverse postoperative outcomes using contemporary prediction-model methodology. Particular attention will be given to model calibration, clinical utility, and internal validation rather than predictor selection based solely on statistical significance.
5,755 studies on the registry are indexed under Colorectal Neoplasms; 1,495 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 250 across 1,261 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 97 studies on the registry; 65 are open to participants now.
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Eligible patients will be aged ≥80 years with newly diagnosed or highly suspected, non-metastatic, technically resectable colorectal cancer involving the colon or upper rectum (lower tumor margin ≥12 cm from the anal verge).
Elective and expedited surgery will be eligible. Expedited surgery refers to resection after initial assessment or stabilization for tumor-related symptoms, including bowel obstruction, when immediate emergency surgery is not required. Patients requiring immediate emergency surgery for perforation, acute complete obstruction, bowel ischemia, or other life-threatening complications will be excluded. Other exclusion criteria will include previous colorectal or major abdominal surgery, metastatic disease, lower rectal cancer requiring neoadjuvant treatment, severe cognitive impairment without a reliable informant, or refusal.
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Exclusion Criteria:
Withdrawal Criteria:
Patients who undergo curative-intent colorectal resection will form the primary analysis cohort
Patients who fail to receive surgical resection will form the primary analysis cohort
90-day major adverse postoperative outcomes (MAPO)
The primary outcome is 90-day major adverse postoperative outcomes (MAPO), defined as the occurrence of any of the following: 1. Clavien-Dindo grade ≥III complication: a postoperative complication requiring surgical, endoscopic, or radiological intervention, or more intensive treatment for life-threatening complications. 2. Unplanned ICU admission: an unexpected transfer to the intensive care unit for postoperative monitoring or organ support. 3. Mechanical ventilation \>48 h: the need for invasive mechanical ventilation for more than 48 hours after surgery. 4. 30- or 90-day all-cause mortality: death from any cause within 30 or 90 days after surgery. 5. Unplanned readmission within 90 days: an unexpected hospital admission within 90 days after discharge from the index hospitalization. The primary composite outcome will be analyzed as a binary variable. Patients will be classified as having MAPO if at least one qualifying event occurs within 90 days after surgery.
Time frame: 90 days after surgery
Major pulmonary complications
Major postoperative pulmonary complications (PPCs) will be defined as clinically significant pulmonary complications occurring within 90 days after surgery that require active treatment or substantial respiratory support. Definitions will be based on the European Perioperative Clinical Outcome (EPCO) recommendations and the Standardized Endpoints in Perioperative Medicine-Consensus for Perioperative Clinical Outcomes (StEP-COMPAC) recommendations. Major PPCs will be analyzed as a binary outcome and reported as the number and proportion of patients who experience at least one qualifying event within 90 days after surgery. Each component will also be reported separately as the number and proportion of affected patients. Patients experiencing multiple pulmonary complications will be counted only once in the composite outcome.
Time frame: 90 days after surgery
KDIGO-defined acute kidney injury
AKI severity will be classified as KDIGO Stage 1-3 according to the highest stage reached based on either serum creatinine or urine output criteria. Any AKI will be defined as KDIGO Stage 1-3, whereas moderate-to-severe AKI will be defined as KDIGO Stage 2-3. Stage 3 AKI will be recorded separately because of its clinical severity and potential need for renal replacement therapy. AKI will be analyzed as a binary outcome, with any AKI (KDIGO Stage 1-3) reported as the number and proportion of affected patients, with a 95% CI. The numbers and proportions of patients in each KDIGO stage will also be reported. Moderate-to-severe AKI (Stages 2-3) and Stage 3 AKI will be summarized separately.
Time frame: 90 days after surgery
Postoperative delirium
Postoperative delirium (POD) will be assessed using the 4 'A's Test (4AT). The 4AT is a brief, validated tool for detecting delirium in older hospitalized patients and has also been evaluated in postoperative settings. A score of ≥4 will be considered a positive delirium screen. Patients will be assessed daily from postoperative day 1 through postoperative day seven or hospital discharge, whichever occurs first. Delirium will be defined as an acute and fluctuating disturbance in attention and awareness accompanied by an additional disturbance in cognition, consistent with established diagnostic criteria. Whenever feasible, patients with a positive 4AT screen (≥4) will undergo clinical confirmation by a trained investigator using DSM-5-based criteria. The incidence of POD will be analyzed as a binary outcome and reported as the number and proportion of affected patients, with a 95% CI. Delirium duration will be summarized using the median and interquartile range (IQR), as appropriate.
Time frame: 90 days after surgery
Anastomotic leakage
Anastomotic leakage (AL) will be defined according to the International Study Group of Rectal Cancer (ISREC) criteria as a defect in the intestinal wall at the anastomotic site, including the suture or staple line, resulting in communication between the intraluminal and extraluminal compartments. The diagnosis may be established by clinical, radiological, endoscopic, or operative findings. Anastomotic leakage will be classified according to the ISREC grading system. Grade A leakage requires no change in clinical management; Grade B leakage requires active therapeutic intervention but can be managed without relaparotomy; and Grade C leakage requires relaparotomy. The incidence of any AL (Grades A-C) will be analyzed as a binary outcome and reported as the number and proportion of affected patients, with a 95% CI. The numbers and proportions of patients with Grade A, B, and C leakage will be reported separately. Grade B and Grade C leakage will also be summarized separately to describe
Time frame: 90 days after surgery
Change in activities of daily living (ADL)
The difference between baseline and follow-up Barthel Index score will be analyzed as a continuous measure before surgery, at hospital discharge, and on postoperative day 90 . The mean change and 95% confidence interval (CI) will be reported, or the median change and interquartile range (IQR) if the data are not normally distributed.
Time frame: 90 days after surgery
Return to pre-admission residence
The proportion of patients who have returned to their pre-admission living arrangement by the end of follow-up will be reported as the number and percentage of patients meeting this outcome, with a 95% CI.
Time frame: 90 days after surgery
Functional independence in basic activities of daily living
The Barthel Index will be assessed before surgery, at hospital discharge, and on postoperative day 90. Changes in score from baseline will be calculated separately for each follow-up assessment and analyzed as a continuous outcome. The mean change and 95% CI will be reported, or the median change and IQR if the data are not normally distributed. Functional independence in basic activities of daily living at each follow-up assessment will be defined as a Barthel Index score of 100 on the 0-100 scale, and the number and percentage of patients meeting this criterion will be reported, with a 95% CI.
Time frame: 90 days after surgery
Change in cognitive screening scores (Mini-Cog)
Cognitive status will be assessed using the Mini-Cog before surgery, at hospital discharge, and on postoperative day 90. Changes in total score (follow-up minus baseline; range, -5 to +5) will be calculated separately for the discharge and day-90 assessments among patients with available paired data. The mean change and 95% CI will be reported, or the median change and IQR if the data are not normally distributed. Changes in Mini-Cog scores will be interpreted as changes in cognitive screening performance rather than definitive evidence of cognitive improvement or decline.
Time frame: 90 days after surgery
Distribution of hospital discharge destinations
The initial discharge destination after the index hospitalization will be obtained from hospital discharge records and classified as the pre-admission residence (including home or a long-term care facility), a rehabilitation facility, or another healthcare facility. Discharge destinations will be summarized using descriptive statistics, with the number and percentage of patients in each category reported alongside 95% CIs for the corresponding proportions.
Time frame: 90 days after surgery
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: Data are available upon reasonable request. Interested researchers can submit project proposals and request data or samples by contacting wangzhanhuai@zju.edu.cn. Ethics approval will be required prior to data collection.
No publications or documents are linked to this record.
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 ↗
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Second Affiliated Hospital, Zhejiang University, School of Medicine