Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum
LASRE
2 other identifiers
interventional
1,070
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedStudy Start
First participant enrolled
November 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2023
CompletedOctober 1, 2021
September 1, 2021
8.1 years
July 8, 2013
September 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
3 years disease-free survival
Disease-free survival is defined as the time from date of surgery to the date of rectal cancer recurrence or metastasis or cancer-related death (locoregional or distant recurrence) .
3 years
Secondary Outcomes (5)
Pathologic outcomes
1 week post operatively
30-day postoperative complications
1 month within operatively
30-day postoperative mortality
30 days post operatively
Overall survival
3 and 5 years post operatively
Locoregional recurrence rate
3 and 5 years post operatively
Other Outcomes (6)
Operative time
Day 1
Conversion to Open Surgery
Day 1
Estimated blood loss
Day 1
- +3 more other outcomes
Study Arms (2)
Arm I
EXPERIMENTALPatients undergo laparoscopic-assisted rectal resection.
Arm II
ACTIVE COMPARATORPatients undergo conventional open rectal resection.
Interventions
Arm I: Patients undergo laparoscopic-assisted rectal resection.
Arm II: Patients undergo conventional open rectal resection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fujian Medical Universitylead
- Sixth Affiliated Hospital, Sun Yat-sen Universitycollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- Peking Union Medical College Hospitalcollaborator
- Peking University Cancer Hospital & Institutecollaborator
- Chinese PLA General Hospitalcollaborator
- Liaoning Cancer Hospital & Institutecollaborator
- RenJi Hospitalcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- West China Hospitalcollaborator
- Shengjing Hospitalcollaborator
- Fujian Cancer Hospitalcollaborator
- The Second Affiliated Hospital of Fujian Medical Universitycollaborator
- The First Affiliated Hospital of Xiamen Universitycollaborator
- Zhangzhou Affiliated Hospital of Fujian Medical Universitycollaborator
- Longyan Affiliated Hospital, Fujian Medical Universitycollaborator
- Fudan Universitycollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Sun Yat-sen Universitycollaborator
- Hubei Cancer Hospitalcollaborator
- Zhejiang Cancer Hospitalcollaborator
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Related Publications (4)
Sun 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: 40804342DERIVEDJiang 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: 39527970DERIVEDJiang 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: 36107416DERIVEDChi 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: 27781241DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pan Chi, MD
Fujian Medical University Union Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Department of General Surgery, Fujian Medical University Union Hospital
Study Record Dates
First Submitted
July 8, 2013
First Posted
July 15, 2013
Study Start
November 12, 2013
Primary Completion
December 31, 2021
Study Completion
June 6, 2023
Last Updated
October 1, 2021
Record last verified: 2021-09