Rectal CarcinomaLASRENCT01899547
Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum
A study testing laparoscopic-assisted rectal resection and conventional open rectal resection in people with Rectal Carcinoma, run by Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Carcinoma
- What is being tested?
- laparoscopic-assisted rectal resection and conventional open rectal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,070 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2013to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- sufficient organ function
- no contraindication to laparoscopic surgery
- without other malignancies in medical history
Who cannot join
- 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
Show all 9Show fewer
- pregnant or breast-feeding women
- history of mental disorder
- participation in another rectal cancer clinical trial relating to surgical technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum : A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial
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
- Rectal Carcinoma
- Being tested
- laparoscopic-assisted rectal resection, conventional open rectal resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic-assisted rectal resectionProcedure or surgery
Arm I: Patients undergo laparoscopic-assisted rectal resection.
conventional open rectal resectionProcedure or surgery
Arm II: Patients undergo conventional open rectal resection.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo laparoscopic-assisted rectal resection. Receives: Procedure: laparoscopic-assisted rectal resection |
| Arm II | Active comparator | Patients undergo conventional open rectal resection. Receives: Procedure: conventional open rectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 3 years
Secondary outcomes (5)
Pathologic outcomes
Pathologic outcomes are defined as TME quality, negative CRM and negative DRM, length of proximal resection margin (PRM), length of DRM, and the number of retrieved lymph nodes.The TME quality was graded based on the criteria proposed by Nagtegaal et al. as complete, nearly complete, or incomplete.Positive resection margin, including circumferential resection margin (CRM) and distal resection margin (DRM), was defined as the presence of cancer cells within 1 mm from the cut edge.
Measured: 1 week post operatively
30-day postoperative complications
Thirty-day postoperative complications included any complications occurring within 30 days after surgery. Postoperative complications were graded according to the Clavien-Dindo classification. Severe complications were defined as Clavien-Dindo III-V.
Measured: 1 month within operatively
30-day postoperative mortality
Thirty-day operative mortality is defined as deaths occurring from any cause during the first 30 postoperative days.
Measured: 30 days post operatively
Overall survival
Overall survival is defined as the time from date of surgery to date of death from any cause.
Measured: 3 and 5 years post operatively
Locoregional recurrence rate
Locoregional recurrence was defined as the presence of any anastomotic, pelvic or perineal tumour documented by clinical and/or pathological examination.
Measured: 3 and 5 years post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study start12 Nov 2013
- Primary completion31 Dec 2021 (estimated)
- Study completion6 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,070 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University, Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Chinese PLA General Hospital, Liaoning Cancer Hospital & Institute, RenJi Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital, Shengjing Hospital, Fujian Cancer Hospital, The Second Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Longyan Affiliated Hospital, Fujian Medical University, Fudan University, Shanghai Zhongshan Hospital, Sun Yat-sen University, Hubei Cancer Hospital, Zhejiang Cancer Hospital
- Responsible party
- Principal investigator, Pan Chi, MD, Fujian Medical University Union Hospital
- Investigators
- Pan Chi, MD, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899547
- Sponsor's protocol ID
- 0925-0586
- Other IDs
- LASRE
- Acronym
- LASRE
- Status last verified
- Sep 2021
- First submitted
- 8 Jul 2013
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang 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.
PubMed 42114353Sun 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.
PubMed 40804342Jiang 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.
PubMed 39527970Jiang 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.
PubMed 36107416Chi 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.
PubMed 27781241
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum : A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT01899547
- Acronym / sponsor ID
- LASRE / 0925-0586
- Conditions
- Rectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University, Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Chinese PLA General Hospital, Liaoning Cancer Hospital & Institute, RenJi Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital, Shengjing Hospital, Fujian Cancer Hospital, The Second Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Longyan Affiliated Hospital, Fujian Medical University, Fudan University, Shanghai Zhongshan Hospital, Sun Yat-sen University, Hubei Cancer Hospital, Zhejiang Cancer Hospital
- Study start
- 12 Nov 2013 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 6 Jun 2023 (estimated)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: laparoscopic-assisted rectal resectionPatients undergo laparoscopic-assisted rectal resection. |
| Arm II | Active comparator | Procedure: conventional open rectal resectionPatients undergo conventional open rectal resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic-assisted rectal resectionArm I: Patients undergo laparoscopic-assisted rectal resection. | Procedure or surgery | Arm I |
| conventional open rectal resectionArm II: Patients undergo conventional open rectal resection. | Procedure or surgery | Arm II |
Primary outcome
3 years disease-free survival
Time frame: 3 years
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) .
5 secondary outcomes
Pathologic outcomes
Time frame: 1 week post operatively
30-day postoperative complications
Time frame: 1 month within operatively
30-day postoperative mortality
Time frame: 30 days post operatively
Overall survival
Time frame: 3 and 5 years post operatively
Locoregional recurrence rate
Time frame: 3 and 5 years post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Derived from this study: PubMed 42114353Wang 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.
- Derived from this study: PubMed 40804342Sun 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.
- Derived from this study: PubMed 39527970Jiang 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.
- Derived from this study: PubMed 36107416Jiang 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.
- Derived from this study: PubMed 27781241Chi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pan Chi, MD principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic-assisted rectal resection and conventional open rectal resection in people with Rectal Carcinoma, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 years disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01899547, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.