Trial · NCT07903129
SGA-OCRC: Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarians With Resectable Colorectal Cancer
NCT07903129, Not yet recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SGA-OCRC: Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarians With Resectable Colorectal Cancer. Trials, record NCT07903129. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903129
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SGA-OCRC: Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarians With Resectable Colorectal Cancer
- NCT number
- NCT07903129
- Status
- Not yet recruiting
- Enrollment
- 1,000 participants, estimated
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Conditions
- Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 90-day major adverse postoperative outcomes (MAPO) | 90 days after surgery | 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. |
| Secondary | Major pulmonary complications | 90 days after surgery | 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. |
| Secondary | KDIGO-defined acute kidney injury | 90 days after surgery | 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. |
| Secondary | Postoperative delirium | 90 days after surgery | 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. |
| Secondary | Anastomotic leakage | 90 days after surgery | 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 |
| Other | Change in activities of daily living (ADL) | 90 days after surgery | 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. |
| Other | Return to pre-admission residence | 90 days after surgery | 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. |
| Other | Functional independence in basic activities of daily living | 90 days after surgery | 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. |
| Other | Change in cognitive screening scores (Mini-Cog) | 90 days after surgery | 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. |
| Other | Distribution of hospital discharge destinations | 90 days after surgery | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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