Clinical trial · Interventional
Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer
Robotic Versus Laparoscopic D3-D4 Lymphadenectomy for Patients With Advanced Colorectal Cancer… A Randomized Prospective Clinical Trial for the Comparison of Oncologic and Functional Outcomes
- 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)
Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy. Our previous study has indicated that, by laparoscopic approach, the extended abdomino-iliac lymphadenectomy, the so-called D3-D4 lymph node dissection, could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes, as compared with traditional open surgery. In the present study, the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial.
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 |
|---|---|---|---|
| Robotic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Laparoscopic surgery
- description
- The patients will undergoing laparoscopic surgery for the treatment of locally advanced colorectal cancer
- type
- ACTIVE_COMPARATOR
- label
- Robotic group
- description
- The patients will undergoing robotic surgery for the treatment of locally advanced colorectal cancer
- interventionNames
- Procedure: Robotic surgery
Primary outcomes (1)
- measure
- The time to recurrence of cancer after curative resection
- timeFrame
- Up to 3 years
- description
- The duration between the time of curative resection and the time to cancer recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically proved adenocarcinoma located at upper rectum (above pelvic peritoneal reflection), recto-sigmoid junction, or distal sigmoid colon (generally 10 to 25 cm above anal verge). Only recto-sigmoid cancers above the peritoneal reflection were investigated because the lymphatic drainage of upper rectum and distal sigmoid colon was along the inferior mesenteric artery to the para-aortic area, and therefore the extent of surgical resection and lymph node mapping were standardized. * Clinically TNM stage III cancers. * Curative robotic or laparoscopic surgery. * American Society of Anesthesiology (ASA) class I to III patients. * Age between 50 and 75 years. This was because patients \>50 years old are generally deemed to be over the reproductive age, and the D3 dissection was considered too aggressive for patients older than 75 years. * Patients who are willing to receive minimally invasive surgical procedures to treat their rectosigmoid cancer. Exclusion Criteria: * Tumors located at other anatomic positions; * Emergency or palliative surgery; * Evidence of disseminated disease or adjacent organ invasion; * Primary tumor mass ≥8 cm in diameter; * Morbidly obese patients (body mass index ≥40 kg/m2); * Previous major surgery of lower abdomen.
References
Publications (0)
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