Clinical trial · Interventional
A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery
A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China
NCT02248038CI-TRIAL-00015686unknownPhase 3ClinicalTrials.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)
The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic surgery | Procedure | — | UNRESOLVED |
| open surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- open surgery
- description
- Conventional procedure
- interventionNames
- Procedure: open surgery
- type
- EXPERIMENTAL
- label
- laparoscopic surgery
- description
- Minimum invasive procedure
- interventionNames
- Procedure: laparoscopic surgery
Primary outcomes (2)
- measure
- 5 years diseases free survival rate
- timeFrame
- five years
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. informed consent 2. single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line 3. cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm 4. age less than 80 years old 5. normal blood routine test and hepatic or renal function test 6. no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction. Exclusion Criteria: 1. severe comorbidity such as heart attack or stroke, malignance in 5 years 2. can not tolerate to general anesthesia, pneumoperitoneum or surgery 3. pregnant or during breast-feeding period 4. attending other clinical trial involving therapy 5. cannot or disagree to attending the clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.