Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum

Rectal Carcinoma Clinical Trial

— LASRE  

Official title:

Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum : A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01899547
• Other study ID #: 0925-0586
• Secondary ID: LASRE
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2013
• Est. completion date: June 6, 2023

Study information

• Verified date: September 2021
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1070
• Est. completion date: June 6, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Rectal Carcinoma

Intervention

Procedure:
• laparoscopic-assisted rectal resection
Arm I: Patients undergo laparoscopic-assisted rectal resection.
• conventional open rectal resection
Arm II: Patients undergo conventional open rectal resection.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (22)

Lead Sponsor

Collaborator

Fujian Medical University

Beijing Cancer Hospital, Chinese PLA General Hospital, Fudan University, Fujian Cancer Hospital, Hubei Cancer Hospital, Liaoning Tumor Hospital & Institute, Longyan Affiliated Hospital, Fujian Medical University, Nanfang Hospital of Southern Medical University, Peking Union Medical College Hospital, RenJi Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, Shengjing Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Sun Yat-sen University, The First Affiliated Hospital of Xiamen University, The Second Affiliated Hospital of Fujian Medical University, West China Hospital, Wuhan Union Hospital, China, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative time	Operative time is defined as the time from skin incision to the completion of skin suture.	Day 1
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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