Preoperative Calorie Restriction and Exercise in Patients With Obesity Undergoing Colorectal Cancer Resection
NCT07928076, Not applicable, Not yet recruiting, Universidad de Granada
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Preoperative Calorie Restriction and Exercise in Patients With Obesity Undergoing Colorectal Cancer Resection | ClinicalTrials.gov |
| NCT number | NCT07928076 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universidad de Granada | ClinicalTrials.gov |
| Conditions | Colorectal Cancer Postoperative Complications | ClinicalTrials.gov |
| Interventions | PRECAREX intervention, Usual Care | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Feasibility of the preoperative intervention | From enrollment to surgery. | Feasibility will be assessed through recruitment and retention rates, attendance at supervised exercise sessions, and adherence to the prescribed calorie restriction. | ClinicalTrials.gov |
| Primary | Safety of the preoperative intervention | From intervention initiation to surgery. | Safety will be assessed by recording adverse events occurring during the intervention, including their severity. | ClinicalTrials.gov |
| Secondary | Comprehensive Complication Index | Within 30 and 90 days after surgery. | Overall postoperative complication burden assessed using the Comprehensive Complication Index, which integrates all postoperative complications into a score ranging from 0 (no complications) to 100 (death). | ClinicalTrials.gov |
| Secondary | Incidence of postoperative complications | Within 30 and 90 days after surgery. | Proportion of participants experiencing at least one postoperative complication, expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Incidence of major postoperative complications | Within 30 and 90 days after surgery. | Proportion of participants experiencing major postoperative complication (CCI \> 20), expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Incidence of postoperative medical complications | Within 30 and 90 days after surgery. | Proportion of participants experiencing at least one medical complication, expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Incidence of postoperative surgical complications | Within 30 and 90 days after surgery. | Proportion of participants experiencing at least one surgical complication, expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Hospital length of stay | Within 90 days after surgery. | Number of days from surgery to discharge from the hospital. | ClinicalTrials.gov |
| Secondary | Emergency department visits | Within 30 and 90 days after surgery. | Proportion of participants attending emergency department after discharge, expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Glycemic profile | Baseline, preoperatively, and 1 month after surgery. | Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the glycemic profile. We will obtain plasma glucose (mg/dL) and insulin (mg/dL) levels. | ClinicalTrials.gov |
| Secondary | Lipid profile | Baseline, preoperatively, and 1 month after surgery. | Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the lipid profile. We will obtain total cholesterol (mg/dL), Light-Density Lipoprotein Cholesterol (mg/dL), High-Density Lipoprotein Cholesterol (mg/dL), and Triglycerides (mg/dL) levels. | ClinicalTrials.gov |
| Secondary | Hepatic transaminases | Baseline, preoperatively, and 1 month after surgery. | Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the hepatic transaminases levels. Serum alanine aminotransferase (ALT), aspartate aminotransferase (GOT), gamma-glutamyl transferase (GGT), and alkaline phosphatase (ALP) will be measured and expressed in units per litre (U/L). | ClinicalTrials.gov |
| Secondary | Immunological blood profiles | Baseline, preoperatively, and 1 month after surgery. | Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the immunological blood profiles. The following parameters will be obtained: Leukocytes (10\*3 uL), Neutrophils (10\*3 uL), Lymphocytes (10\*3 uL), Monocytes (10\*3 uL), Eosinophils (10\*3 uL), Basophils (10\*3 uL) and LUC cells (10\*3 uL). | ClinicalTrials.gov |
| Secondary | Red cells | Baseline, preoperatively, and 1 month after surgery. | Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the red cells levels, including red blood cell count (×10\^12/L), haemoglobin (g/dL), haematocrit (%), mean corpuscular volume (fL), mean corpuscular haemoglobin (pg), mean corpuscular haemoglobin concentration (g/dL), and red cell distribution width (%). | ClinicalTrials.gov |
| Secondary | Tumour markers | Baseline, preoperatively, and 1 month after surgery. | Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the tumour markers levels (CA 19-9, CEA, CA 125, TPA and CA 15.3; all will be expressed as pg/mL)) | ClinicalTrials.gov |
| Secondary | Systolic blood pressure | Baseline, preoperatively, and 1 month after surgery. | Changes in systolic blood pressure will be assessed by blood pressure monitor. | ClinicalTrials.gov |
| Secondary | Diastolic lood pressure | Baseline, preoperatively, and 1 month after surgery. | Changes in diastolic blood pressure will be assessed by blood pressure monitor. | ClinicalTrials.gov |
| Secondary | Cardiorespiratory fitness | Baseline, preoperatively, and 1 month after surgery. | Changes in cardiorespiratory fitness assessed using the six-minute walk test. | ClinicalTrials.gov |
| Secondary | Upper body muscular strength | Baseline, preoperatively, and 1 month after surgery. | Changes in upper body muscular strength assessed through handgrip test. | ClinicalTrials.gov |
| Secondary | Lower body muscular strength and power | Baseline, preoperatively, and 1 month after surgery. | Changes in lower body muscular strength will be assessed using the 30 seconds sit-to-stand test. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 8
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)