A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer

Rectal Cancer Clinical Trial

— RLAPR  

Official title:

A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985698
• Other study ID #: RLAPR
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2019

Study information

• Verified date: March 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.

Description:

Patients will be eligible for inclusion if their primary tumors is low rectal cancer. Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: December 2019
• Est. primary completion date: December 2016
• 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 anal verge as determined by colonoscopy withdrawing and digital rectal examination
• No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc
• Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI
• No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
• Suitable for both robot-assisted and laparoscopic surgery
• American Society of Anesthesiologists (ASA) class I - III
• No other preoperative treatment except neoadjuvant chemoradiotherapy
• Informed consent

Exclusion Criteria:

• Tumors assessed as cT1N0 and suitable for local excision
• Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
• More than one colorectal tumor
• Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
• Schedules need for other synchronous colon surgery
• Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
• Pregnancy or lactation
• Patients and/or family members can not understand and accept this study
• Patients received chemoradiotherapy or other anti-tumor therapy before surgery

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Robotic-assisted resection.
Robotic-assisted abdominoperineal resection.
• Laparoscopic resection
Laparoscopic abdominoperineal resection

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	operative time	Time from cutting the skin to suturing the incision during the surgery, recorded in minute	Day 1
Other	rate of conversion to open surgery	The rate of patients actually receiving open surgery in robotic or laparoscopic surgery groups.	Day 1
Other	estimated blood loss	Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.	Day 1
Other	circumferential resection margin	The circumferential margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.	10 days post operatively
Other	proximal/distal resection margin	The proximal/distal resection margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.	10 days post operatively
Other	number of retrieved lymph nodes	It will be reported according to the post-operative pathology.	10 days post operatively
Other	postoperative hospital stay	The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.	30 days post operatively
Other	self reported bladder function	This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)	at postoperative 3, 6 and 1 2 months
Other	self reported sexual function for male patients	This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).	at postoperative 3, 6 and 1 2 months
Other	self reported sexual function for female patients	This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).	at postoperative 3, 6 and 1 2 months
Primary	postoperative complications	postoperative complications related to operation	30 days post operatively
Secondary	operative mortality	death occurred 30 days after operation	30 days post operatively
Secondary	disease-free survival	disease-free survival rate at 3 years after operation	3 years
Secondary	overall survival	overall survival rate at 3 and 5 years after operation	3 and 5 years
Secondary	locoregional recurrence rate	local recurrence rate at 3 and 5 years after operation	3 and 5 years