Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum (LASRE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Carcinoma
• Intervention / Treatment: Procedure: laparoscopic-assisted rectal resection; Procedure: conventional open rectal resection

• Study Type: Interventional
• Enrollment (Actual): 1070
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm I; Patients undergo laparoscopic-assisted rectal resection.	Procedure: laparoscopic-assisted rectal resection; Arm I: Patients undergo laparoscopic-assisted rectal resection.
ACTIVE_COMPARATOR: Arm II; Patients undergo conventional open rectal resection.	Procedure: conventional open rectal resection; Arm II: Patients undergo conventional open rectal resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Collaborators: Zhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; Peking Union Medical College Hospital; Shanghai Zhongshan Hospital; Fujian Cancer Hospital; Chinese PLA General Hospital; RenJi Hospital; West China Hospital; Hubei Cancer Hospital; Peking University Cancer Hospital & Institute; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shengjing Hospital; Nanfang Hospital of Southern Medical University; Sixth Affiliated Hospital, Sun Yat-sen University; Wuhan Union Hospital, China; Liaoning Tumor Hospital & Institute; 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
• Investigators: Principal Investigator: Pan Chi, MD, Fujian Medical University Union Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2013
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): June 6, 2023

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (ESTIMATE): July 15, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 0925-0586; LASRE (REGISTRY: Laparoscopy-assisted Surgery for Carcinoma of the Low Rectum)