Clinical trial · Interventional
Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
NCT01269060CI-TRIAL-00007740completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted. However, there are not sufficient evidences for single incision colon surgery in colon cancer. The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon 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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single Incision Laparoscopic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single incision sigmoidectomy
- description
- Single incision laparoscopic sigmoidectomy for sigmoid colon cancer
- interventionNames
- Procedure: Single Incision Laparoscopic Surgery
Primary outcomes (1)
- measure
- Harvested numbers of lymph node
- timeFrame
- Within the first 7 days (plus or minus 3 days) after surgery
Secondary outcomes (1)
- measure
- Postoperative mortality, morbidity
- timeFrame
- Within 30 days after operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients should sign a written informed consent * Age between 18-80 * Patients have sigmoid colon cancer that was proved by pathology * Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3 * Adequate kidney function Creatinine ≤ 1.5 mg/dl * No remarkable evidence of heart dysfunction and lung dysfunction Exclusion Criteria: * Distant metastasis * Tumor diameter \> 5 cm * Other organ invasion * Intestinal obstruction and stent insertion status * Patient was used steroid * Patients undergo emergency surgery with multiple symptoms * Other organ cancer history (except who had radical excision for skin cancer) * Presence of other serious disease * Mentally ill patients * Legally unable to participate in clinical trial * Lactating or pregnant women * Patients who will obviously fail to regular follow-up visit or will be off study voluntarily * Not eligible to participate for other reasons by doctor's decision
References
Publications (0)
Data not yet available
No reference posted for this study.