Clinical trial · Interventional
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial
NCT02817126CI-TRIAL-00057261REALunknownN/AClinicalTrials.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 evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic 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 Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic resection | Procedure | — | UNRESOLVED |
| Robot-assisted resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robot-assisted surgery
- description
- Patients undergo robot-assisted resections.
- interventionNames
- Procedure: Robot-assisted resection
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic surgery
- description
- Patients undergo laparoscopic resections.
- interventionNames
- Procedure: Laparoscopic resection
Primary outcomes (1)
- measure
- Locoregional recurrence rate
- timeFrame
- 3 years after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * American Society of Anesthesiologists (ASA) class I - III; * Histologically proved rectal adenocarcinoma; * Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy; * Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI; * No evidence of distant metastases; * No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri; * Suitable for both robotic and laparoscopic surgery; * Informed consent. Exclusion Criteria: * Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy; * Tumors assessed as cT1N0 and suitable for local excision; * Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery; * Multiple colorectal tumors or other schedules needing for synchronous colon surgery; * Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.); * Co-existent inflammatory bowel disease; * Pregnancy or lactation; * Patients received treatment other than preoperative radio- or chemoradiotherapy.
References
Publications (2)
- DERIVEDFeng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Wei Y, Liang F, He G, Xu J; REAL Study Group. Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial. JAMA. 2025 Jul 8;334(2):136-148. doi: 10.1001/jama.2025.8123. PMID 40455621
- DERIVEDFeng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Liang F, He G, Wei Y, Xu J; REAL Study Group. Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004. doi: 10.1016/S2468-1253(22)00248-5. Epub 2022 Sep 8. PMID 36087608