Clinical trial NCT01899547: Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum
Official title: Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum : A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Carcinoma
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Nanfang Hospital, Southern Medical University
name: Peking Union Medical College Hospital
name: Peking University Cancer Hospital & Institute
name: Chinese PLA General Hospital
name: Liaoning Cancer Hospital & Institute
name: RenJi Hospital
name: Wuhan Union Hospital, China
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: West China Hospital
name: Shengjing Hospital
name: Fujian Cancer Hospital
name: The Second Affiliated Hospital of Fujian Medical University
name: The First Affiliated Hospital of Xiamen University
name: Zhangzhou Affiliated Hospital of Fujian Medical University
name: Longyan Affiliated Hospital, Fujian Medical University
name: Fudan University
name: Shanghai Zhongshan Hospital
name: Sun Yat-sen University
name: Hubei Cancer Hospital
name: Zhejiang Cancer Hospital
First posted: 2013-07-15
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 3 years disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Pathologic outcomes
timeFrame: 1 week post operatively
measure: 30-day postoperative complications
timeFrame: 1 month within operatively
measure: 30-day postoperative mortality
timeFrame: 30 days post operatively
measure: Overall survival
timeFrame: 3 and 5 years post operatively
measure: Locoregional recurrence rate
timeFrame: 3 and 5 years post operatively
Other outcomes:
measure: Operative time
timeFrame: Day 1
measure: Conversion to Open Surgery
timeFrame: Day 1
measure: Estimated blood loss
timeFrame: Day 1
measure: Length of hospital stay
timeFrame: from the completion of the surgery till discharge from hospital
measure: Patient self-reported bladder and sexual function
timeFrame: at postoperative 3,6 and 12 months
measure: Health related quality of life
timeFrame: at postoperative 3,6 and 12 months
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Pan Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.