Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum
NCT ID: NCT01899547
Last Updated: 2021-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1070 participants
INTERVENTIONAL
2013-11-12
2023-06-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer
NCT04481659
Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer
NCT05953662
Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
NCT05911152
Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer
NCT04559087
Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
NCT04527861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Patients undergo laparoscopic-assisted rectal resection.
laparoscopic-assisted rectal resection
Arm I: Patients undergo laparoscopic-assisted rectal resection.
Arm II
Patients undergo conventional open rectal resection.
conventional open rectal resection
Arm II: Patients undergo conventional open rectal resection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laparoscopic-assisted rectal resection
Arm I: Patients undergo laparoscopic-assisted rectal resection.
conventional open rectal resection
Arm II: Patients undergo conventional open rectal resection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Peking Union Medical College Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Chinese PLA General Hospital
OTHER
Liaoning Cancer Hospital & Institute
OTHER
RenJi Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
West China Hospital
OTHER
Shengjing Hospital
OTHER
Fujian Cancer Hospital
OTHER_GOV
The Second Affiliated Hospital of Fujian Medical University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Zhangzhou Affiliated Hospital of Fujian Medical University
OTHER
Longyan Affiliated Hospital, Fujian Medical University
UNKNOWN
Fudan University
OTHER
Shanghai Zhongshan Hospital
OTHER
Sun Yat-sen University
OTHER
Hubei Cancer Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Fujian Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pan Chi, MD
Chief of Department of General Surgery, Fujian Medical University Union Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pan Chi, MD
Role: PRINCIPAL_INVESTIGATOR
Fujian Medical University Union Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Jiang 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.
Jiang 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.
Chi 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LASRE
Identifier Type: REGISTRY
Identifier Source: secondary_id
0925-0586
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.