Clinical trial · Interventional
Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
NCT02682589CI-TRIAL-00022910OLCMECCunknownPhase 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)
Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced 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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
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
- Patients undergo open CME. A standard midline incision carefully protected is made through the abdominal wall and the abdominal cavity is explored. A colectomy with CME is performed with the removal of the afflicted colon and its accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia.
- interventionNames
- Procedure: Open surgery
- type
- EXPERIMENTAL
- label
- Laparoscopic surgery
- description
- Patients undergo laparoscopic CME. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with carbon dioxide to allow access and visualization. The abdominal cavity is explored. A colectomy with CME is performed using laparoscopic-assisted techniques. A 6-8cm midline auxiliary incision is made for specimen extraction and anastomosis.
- interventionNames
- Procedure: Laparoscopic surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients suitable for curative surgery over 18 years old; * American Society of Anesthesiologists(ASA) grade I-III; * Pathological diagnosis of adenocarcinoma; * Tumor located between the cecum and sigmoid colon; * Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis; * Informed consent; * No preoperative chemoradiotherapy; * No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease. Exclusion Criteria: * Pregnant patient; * History of psychiatric disease; * Use of systemic steroids; * Conversion to laparotomy; * Simultaneous or simultaneous multiple primary colorectal cancer; * Preoperative imaging examination results show: 1. Tumor involves the surrounding organs and combined organ resection need to be done; 2. distant metastasis; 3. unable to perform R0 resection; * Postoperative pathology of T1-T2 N0; * History of any other malignant tumor in recent 5 years; * Patients need emergency operation: mechanic ileus, perforation. * Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
References
Publications (0)
Data not yet available
No reference posted for this study.