Clinical trial · Interventional
A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer
A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer
NCT01985698CI-TRIAL-00050537RLAPRcompletedN/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)
In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal 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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic resection | Procedure | — | UNRESOLVED |
| Robotic-assisted resection. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic-assisted resection
- description
- patients with low rectal cancer receiving robotic-assisted abdominoperineal resection.
- interventionNames
- Procedure: Robotic-assisted resection.
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic resection
- description
- patients with low rectal cancer receiving laparoscopic abdominoperineal resection.
- interventionNames
- Procedure: Laparoscopic resection
Primary outcomes (1)
- measure
- postoperative complications
- timeFrame
- 30 days post operatively
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven rectal adenocarcinoma * Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination * No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc * Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI * 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 robot-assisted and laparoscopic surgery * American Society of Anesthesiologists (ASA) class I - III * No other preoperative treatment except neoadjuvant chemoradiotherapy * Informed consent Exclusion Criteria: * Tumors assessed as cT1N0 and suitable for local excision * Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery * More than one colorectal tumor * Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease * Schedules need for other synchronous colon surgery * Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III) * Pregnancy or lactation * Patients and/or family members can not understand and accept this study * Patients received chemoradiotherapy or other anti-tumor therapy before surgery
References
Publications (1)
- DERIVEDFeng Q, Tang W, Zhang Z, Wei Y, Ren L, Chang W, Zhu D, Liang F, He G, Xu J. Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial. J Surg Oncol. 2022 Dec;126(8):1481-1493. doi: 10.1002/jso.27076. Epub 2022 Aug 29. PMID 36036889