Clinical trial · Interventional
Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery
Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study has never been opened to accrual at COH. Study to be closed at COH due to the lack of qualified robotic colorectal surgeons.
Summary
Brief summary (as posted)
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer. PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see how well it works compared to laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional laparoscopic surgery | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| robotic-assisted laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients undergo standard conventional laparoscopic resection.
- interventionNames
- Procedure: conventional laparoscopic surgery
- Procedure: quality-of-life assessment
- Other: questionnaire administration
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo robotic-assisted laparoscopic resection.
- interventionNames
- Procedure: robotic-assisted laparoscopic surgery
- Procedure: quality-of-life assessment
- Other: questionnaire administration
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Able to provide written informed consent * Diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged T1-3, N0-2, M0 by CT and MRI or transrectal ultrasound) * Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure * Fit for robotic-assisted or standard laparoscopic rectal resection * ASA =\< 3 * Capable of completing required questionnaires at time of consent Exclusion * Benign lesions of the rectum * Cancers of the anal canal * Locally advanced cancers not amenable to curative surgery * Locally advanced cancers requiring en bloc multi-visceral resection * Synchronous colorectal tumours requiring multi-segment surgical resection * Co-existent inflammatory bowel disease * Clinical or radiological evidence of metastatic spread * Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable; for other cases please discuss with Chief Investigator via CTRU) * History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements * Pregnancy * Participation in another rectal cancer clinical trial relating to surgical technique
References
Publications (0)
Data not yet available