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| ID | Type | Description | Link |
|---|---|---|---|
| LASRE | Registry Identifier | Laparoscopy-assisted Surgery for Carcinoma of the Low Rectum |
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| Name | Class |
|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Peking Union Medical College Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo laparoscopic-assisted rectal resection. |
|
| Arm II | Active Comparator | Patients undergo conventional open rectal resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic-assisted rectal resection | Procedure | Arm I: Patients undergo laparoscopic-assisted rectal resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time is defined as the time from skin incision to the completion of skin suture. | Day 1 |
| Conversion to Open Surgery | The conversion is defined as any part of the mesorectal dissection using the traditional open surgery. The surgeon decided the conversion after considering patient safety, technical difficulties, and relevant conditions influencing the completion of TME. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pan Chi, MD | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114353 | Derived | 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. | |
| 40804342 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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 |
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| conventional open rectal resection | Procedure | Arm II: Patients undergo conventional open rectal resection. |
|
| 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. | 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. | 30 days post operatively |
| Overall survival | Overall survival is defined as the time from date of surgery to date of death from any cause. | 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. | 3 and 5 years post operatively |
| Day 1 |
| Estimated blood loss | Estimated blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation. | Day 1 |
| Length of hospital stay | Duration of hospital stay measured from the day of surgery until the day of discharge from hospital. | from the completion of the surgery till discharge from hospital |
| Patient self-reported bladder and sexual function | Patient self-reported bladder and sexual function as assessed by the International Prostatic Symptom Score(I-PSS©) for male and female bladder function and the International Index of Erectile Function (IIEF) Female Sexual Function Index(FSFI©) for sexual function. | at postoperative 3,6 and 12 months |
| Health related quality of life | Health related quality of life assessed by EORTC CR29 score, EORTC CR30 score | at postoperative 3,6 and 12 months |
| 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. |
| 39527970 | Derived | 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. |
| 36107416 | Derived | 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. |
| 27781241 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |