Clinical trial · Interventional
Double Blinded Randomized Clinical Trial of the Effect of Open Versus Laparoscopic Colectomy on Neutrophils in Patients With Colon Cancer
- 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)
The purpose of this study is: * to determine neutrophil activity in patients with colon cancer, * to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value, * to elucidate the relationship between serum sFas, sFasL and IL - 17 levels and clinicopathologic features of colon cancer, * to compare the influence of laparoscopic and conventional procedures on postoperative serum sFas and sFasL levels in colon cancer patients * to compare the influence of laparoscopic and conventional procedures on postoperative serum IL - 17 levels in colon cancer patients * to compare the influence of laparoscopic and conventional procedures on postoperative neutrophil functions * to confirm the expression of FasL protein in human colorectal cancer and elucidate the relationship between FasL expression and clinicopathologic features of the disease, to establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the relationship between FasL expression and clinicopathologic features of the disease * to determine the functional activity of tumour infiltrating neutrophils
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest | Other | — | UNRESOLVED |
| Therapeutic conventional colorectal surgery | Procedure | — | UNRESOLVED |
| Therapeutic laparoscopic colorectal surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- ARM I - Open colorectal surgery
- description
- Open colorectal surgery
- interventionNames
- Procedure: Therapeutic conventional colorectal surgery
- type
- EXPERIMENTAL
- label
- ARM II - Laparoscopic colorectal surgery
- description
- Laparoscopic colorectal surgery
- interventionNames
- Procedure: Therapeutic laparoscopic colorectal surgery
- type
- OTHER
- label
- Control - reference value
- description
- Blood samples from healthy volunteers will be obtained at one time point.Peripheral blood samples will be obtained into tubes with no additive (BD Vacutainer System, Plymouth, UK).Samples will be processed to serum. Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA)using specific anti-Fas MoAbs, Human sFas Immunoassay. Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay. Serum concentration of IL - 17 will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using Human IL-17 Immunoassay. . Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube. burst neutrophil production will be determined quantitatively by flow cytometry as described by Rothe using a commercial kit Bursttest Kit.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: All patients will be informed that additional blood and tissue samples will be taken during perioperative period for colon cancer research, and written consent will be obtained. Informed consent will be also obtained from each healthy volunteer. Patients with the clinical diagnosis of colorectal cancer based on colonoscopy following histological confirmation will recruited. They should be suitable for elective surgical resection of the tumour along with lymph node dissection by right and left hemicolectomy, sigmoid colectomy, and anterior resection. Clinicopathologic characteristics of these patients will be investigated based on TNM classification of malignant tumours and modified Dukes classification Inclusion criteria; age between 18 and 80 years; colorectal cancer with single tumour locating at cecum, ascending colon, descending colon, sigmoid colon or recto sigmoid junction (distance from anal verge more than 15 cm); ASA I-III; and informed consent. Exclusion criteria; patient refusal to participate in the prospective data collection; prior midline laparotomy; emergency surgery or urgent operation within 24 h after admission to the hospital; conversion to laparotomy; mechanic ileus; perforation or abscess with septic inflammatory response syndrome; planned stoma, low anterior resection or rectal extirpation; known immunological dysfunction (human immunodeficiency virus infection); presence of ongoing infection or infective chronic diseases; severe cardiovascular disease (New York Heart Association class higher than 3) or pulmonary insufficiency (severe pulmonary emphysema, interstitial pneumonitis, arterial PO2\<79 mmHg); advanced liver disease (Child-Pugh class C); synchronous or metachronous (within five years) malignancy; pregnant or lactating women; continuous systemic steroid therapy; drug addiction; previous chemotherapy, radiotherapy or immune therapy.
References
Publications (0)
Data not yet available