Clinical trial · Interventional
Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum
Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum : A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial
NCT01899547CI-TRIAL-00054219LASREunknownN/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 laparoscopy-assisted surgery for low rectal carcinoma compared with open 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 |
|---|---|---|---|
| conventional open rectal resection | Procedure | — | UNRESOLVED |
| laparoscopic-assisted rectal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo laparoscopic-assisted rectal resection.
- interventionNames
- Procedure: laparoscopic-assisted rectal resection
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients undergo conventional open rectal resection.
- interventionNames
- Procedure: conventional open rectal resection
Primary outcomes (1)
- measure
- 3 years disease-free survival
- timeFrame
- 3 years
- description
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 dentate line as determined by rigid proctoscopy * diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision * T3-4a,N0 or T1-4a,N1-2 treated with neoadjuvant chemoradiotherapy * no evidence of distant metastases * tumor size \<6cm * sufficient organ function * no contraindication to laparoscopic surgery * without other malignancies in medical history Exclusion Criteria: * concurrent or previous diagnosis of invasive cancer within 5 years * locally advanced cancers requiring en bloc multivisceral resection * intestinal obstruction * intestinal perforation * history of colorectal surgery * American Society of Anesthesiologists(ASA) class 4 or 5 * pregnant or breast-feeding women * history of mental disorder * participation in another rectal cancer clinical trial relating to surgical technique
References
Publications (5)
- DERIVEDWang X, Jiang W, Sun Y, Tang Y, Huang Y, Chi P; LASRE Study Group. Distal margin length after neoadjuvant chemoradiotherapy has no prognostic impact in low rectal cancer once the margin is microscopically negative: A multicentre equivalence analysis. Eur J Surg Oncol. 2026 Jun;52(6):111465. doi: 10.1016/j.ejso.2026.111465. Epub 2026 Feb 10. PMID 42114353
- DERIVEDSun Y, Tang Z, Jiang W, Wang X, Huang Y, Chi P. Textbook outcome in low rectal cancer patients undergoing laparoscopic or open surgery: 3-year results from the multicentric LASRE Trial. Int J Colorectal Dis. 2025 Aug 13;40(1):177. doi: 10.1007/s00384-025-04976-w. PMID 40804342
- DERIVEDJiang W, Xu J, Cui M, Qiu H, Wang Z, Kang L, Deng H, Chen W, Zhang Q, Du X, Yang C, Guo Y, Zhong M, Ye K, You J, Xu D, Li X, Xiong Z, Tao K, Ding K, Zang W, Feng Y, Pan Z, Wu A, Huang F, Huang Y, Wei Y, Su X, Chi P; LASRE trial investigators. Laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): 3-year survival outcomes of a multicentre, randomised, controlled, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 Jan;10(1):34-43. doi: 10.1016/S2468-1253(24)00273-5. Epub 2024 Nov 8. PMID 39527970
- DERIVEDJiang WZ, Xu JM, Xing JD, Qiu HZ, Wang ZQ, Kang L, Deng HJ, Chen WP, Zhang QT, Du XH, Yang CK, Guo YC, Zhong M, Ye K, You J, Xu DB, Li XX, Xiong ZG, Tao KX, Ding KF, Zang WD, Feng Y, Pan ZZ, Wu AW, Huang F, Huang Y, Wei Y, Su XQ, Chi P; LASRE trial investigators. Short-term Outcomes of Laparoscopy-Assisted vs Open Surgery for Patients With Low Rectal Cancer: The LASRE Randomized Clinical Trial. JAMA Oncol. 2022 Sep 15;8(11):1607-15. doi: 10.1001/jamaoncol.2022.4079. Online ahead of print. PMID 36107416
- DERIVEDChi P. [Laparoscopic total mesorectum excision with the guidance of membrane anatomy]. Zhonghua Wei Chang Wai Ke Za Zhi. 2016 Oct 25;19(10):1088-1091. Chinese. PMID 27781241