Clinical trial · Interventional
Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer
Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer --an Open Label, Multicenter, Prospective Phase Ⅱ Study
- 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)
Colorectal cancer is the third most common malignant tumor. Radical resection is the mainstay of treatments for non-metastatic colorectal cancer. In case of traditional laparoscopic surgery, inexperienced assistants are likely to cause side injuries and interfere surgeon due to limited operating space. Reduced-port laparoscopic surgery has only 3 ports for surgeon and observer, and the surgeon completes the surgery independently, which increases the difficulty of the operation. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery avoids the prolongation of the operation time and parainjury caused by inexperienced assistant. Reduced-port laparoscopy reduces some surgical incisions, resulting in less pain and faster recovery. Reduced-port laparoscopy also reduces the consumables, human resources and medical expenses. This study aims to evaluate the curative effect and safety of reduced-port laparoscopic surgery versus conventional laparoscopic surgery for resectable colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional laparoscopic surgery | Procedure | — | UNRESOLVED |
| Reduced-port laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reduced-port laparoscopic surgery
- description
- locations of trocars: A 10mm trocar is placed in the supraumbilical or subumbilicus as an observation port, and the surgeon inserts a 10mm trocar and a 5mm trocar on the ipsilateral side of the patient according to the intraoperative situation, as the main operation port and the secondary operation port, and the positions of the trocars follow the principle that the lesion is located at the triangular apex of the two trocars.
- interventionNames
- Procedure: Reduced-port laparoscopic surgery
- type
- ACTIVE_COMPARATOR
- label
- conventional laparoscopic surgery
- description
- locations of trocars: A 10mm trocar is placed in the supraumbilicus or subumbilicus as an observation port, and the surgeon inserts a 10mm trocar and a 5mm trocar in a suitable position according to the intraoperative situation as the main operation port and the secondary operation port. The assistant places two 5mm trocars in the appropriate position as the assistant operation port.
- interventionNames
- Procedure: conventional laparoscopic surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-80 years old; 2. Pathological diagnosis of colorectal adenocarcinoma (including high, medium and low-differentiated adenocarcinoma, excluded: mucinous adenocarcinoma, signet ring cell carcinoma); 3. Eastern Cooperative Oncology Group (ECOG) is 0-1 points; 4. Chest, whole abdomen, pelvic enhanced CT confirm colon or upper rectal cancer, without distant metastasis; 5. No other multiple primary tumors; 6. No organ dysfunction; 7. The patient and his/her family are able to understand the study protocol and are willing to participate in the study and sign informed consent. Exclusion Criteria: 1. Age \< 18, or \> 80 years old; 2. Combined with simultaneous or heterogeneous (within 5 years) malignant tumors; 3. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who require emergency surgery; 4. Joint organ resection is required; 5. ASA Class IV or V; 6. Suffering from a serious mental illness; 7. Patients with severe emphysema, interstitial pneumonia or ischemic heart disease, etc. who cannot tolerate surgery; 8. Continuous systemic steroid therapy within 1 months; 9. Patients or families are unable to understand the conditions and objectives of this study.
References
Publications (0)
Data not yet available