Clinical trial · Interventional
A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer
- 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)
This study sets up the final study end point and three detailed goals as the following. The main objective of study: This trial is done to assess the safety and benefit of robotic resection compared with conventional laparoscopy-assisted resection for curative treatment of patients with cancer of the mid or low rectum. Detailed goal of study: The primary endpoint: This study is designed to assess whether robotic surgical system improves the quality of rectal cancer surgery, especially in total mesorectal excision quality and a circumferential margin positivity rate The secondary endpoint: This study aims to compare 3- and 5-year disease-free survival and overall survival after robot and laparoscopic resection of distal rectal cancer. This study will also assess the pelvic autonomic nerve preservation, short-term morbidity, pathological quality (i.e. number of harvested lymph node), local recurrence, and blood loss during 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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
| robot-assisted surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic LAR
- description
- Individuals who underwent robot-assisted surgery for primary rectal cancer
- interventionNames
- Procedure: robot-assisted surgery
- type
- ACTIVE_COMPARATOR
- label
- Lap LAR
- description
- Individuals who underwent laparoscopic surgery for primary rectal cancer
- interventionNames
- Procedure: Laparoscopic surgery
Primary outcomes (1)
- measure
- Surgical quality based on pathological examination
- timeFrame
- up to 4 weeks after operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Eligibility rule of enrollment * Rectal adenocarcinoma that were 10 cm or less from the anal verge * at least 18 years old \& at most 80 years old * Clinically diagnosed cT3N0-2 disease * Clinical diagnosis of carcinoma involving a single rectal segment * Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography Exclusion Criteria: * The presence of metastasis to the liver, lung, brain, bone, abdominal aortic lymph node, lateral pelvic wall lymph node and inguinal lymph node * A past history of the cancer occurring in other body areas than the rectal cancer (except for a past history of the radical resection due to skin cancer) * Severe cardiac diseases or failure * Severe pulmonary diseases or dysfunction * The presence of psychiatric diseases * The concurrent presence of other severe medical diseases * An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
References
Publications (0)
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