Clinical trial · Observational
Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer
The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma (CRC) | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Complications | — | UNRESOLVED | — |
| Endothelial Dysfunction | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling for laboratory analyses before and after surgery | Procedure | — | UNRESOLVED |
| Skin and subcutaneous tissue sampling for histopathological analysis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients who received neoadjuvant therapy.
- description
- The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy.
- interventionNames
- Procedure: Skin and subcutaneous tissue sampling for histopathological analysis
- Procedure: Blood sampling for laboratory analyses before and after surgery
- label
- Patients who did not receive neoadjuvant therapy, control group.
- description
- The control group will include 34 patients undergoing colorectal cancer surgery who have not received neoadjuvant therapy.
- interventionNames
- Procedure: Skin and subcutaneous tissue sampling for histopathological analysis
- Procedure: Blood sampling for laboratory analyses before and after surgery
Primary outcomes (2)
- measure
- Analysis of microvascular density
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged ≥18 years with histologically confirmed colorectal cancer * Planned surgical treatment for colorectal cancer (either laparoscopic LPSC or open laparotomy) * Ability to understand the study protocol and provide written informed consent. * Both sexes * ASA classification II or III * Patients who received neoadjuvant therapy is investigational group and patients who did not receive neoadjuvant therapy is control group Exclusion Criteria: * Age \<18 years * Patients who are not conscious, not oriented, or unable to provide informed consent * Patients unable to understand the study protocol * Emergency surgical cases * Patients on chronic corticosteroid therapy
References
Publications (7)
- BACKGROUNDElawa S, Fredriksson I, Steinvall I, Zotterman J, Farnebo S, Tesselaar E. Skin perfusion and oxygen saturation after mastectomy and radiation therapy in breast cancer patients. Breast. 2024 Jun;75:103704. doi: 10.1016/j.breast.2024.103704. Epub 2024 Mar 6. PMID 38460441
- BACKGROUNDAfolabi H, Salleh SM, Zakaria Z, Ch'ng ES, Mohd Nafi SN, Abdul Aziz AAB, Al-Mhanna SB, Wada Y, Abdulrahman AS. The Prediction of Survival Outcome and Prognosis Factor in Association with Comorbidity Status in Patients with Colorectal Cancer: A Research-Based Study. Healthcare (Basel). 2022 Sep 5;10(9):1693. doi: 10.3390/healthcare10091693. PMID 36141305
- BACKGROUNDChen CC, Wu ML, Huang KC, Huang IP, Chung YL. The Effects of Neoadjuvant Treatment on the Tumor Microenvironment in Rectal Cancer: Implications for Immune Activation and Therapy Response. Clin Colorectal Cancer. 2020 Dec;19(4):e164-e180. doi: 10.1016/j.clcc.2020.04.002. Epub 2020 Apr 16. PMID 32387305
- BACKGROUNDAdmasu FT, Dejenie TA, Ayehu GW, Zewde EA, Dessie G, Adugna DG, Enyew EF, Geto Z, Abebe EC. Evaluation of thromboembolic event, basic coagulation parameters, and associated factors in patients with colorectal cancer: a multicenter study. Front Oncol. 2023 May 2;13:1143122. doi: 10.3389/fonc.2023.1143122. eCollection 2023. PMID 37205202
- BACKGROUNDLee S, Huh SJ, Oh SY, Koh MS, Kim SH, Lee JH, Han JY, Choi HJ, Kim SJ, Kim HJ. Clinical significance of coagulation factors in operable colorectal cancer. Oncol Lett. 2017 Jun;13(6):4669-4674. doi: 10.3892/ol.2017.6058. Epub 2017 Apr 20. PMID 28599468
- BACKGROUNDGamboa AC, Lee RM, Turgeon MK, Varlamos C, Regenbogen SE, Hrebinko KA, Holder-Murray J, Wiseman JT, Ejaz A, Feng MP, Hawkins AT, Bauer P, Silviera M, Maithel SK, Balch GC. Impact of Postoperative Complications on Oncologic Outcomes After Rectal Cancer Surgery: An Analysis of the US Rectal Cancer Consortium. Ann Surg Oncol. 2021 Mar;28(3):1712-1721. doi: 10.1245/s10434-020-08976-8. Epub 2020 Sep 23.