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A Trial of Robotic-assisted Versus Laparoscopic Versus Open Abdominoperineal Resection for Treating Low Rectal Cancer (RLOAPR)

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ClinicalTrials.gov Identifier: NCT01985698
Recruitment Status : Unknown
Verified October 2016 by Xu jianmin, Fudan University.
Recruitment status was:  Recruiting
First Posted : November 15, 2013
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

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

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Robotic-assisted resection. Procedure: Laparoscopic resection Procedure: Open surgery Not Applicable

Detailed 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) versus open abdominoperineal resection (arm C).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Versus Open Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer
Study Start Date : November 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Robotic-assisted resection
patients with low rectal cancer receiving robotic-assisted abdominoperineal resection.
Procedure: Robotic-assisted resection.
Robotic-assisted abdominoperineal resection.

Experimental: Laparoscopic resection
patients with low rectal cancer receiving laparoscopic abdominoperineal resection.
Procedure: Laparoscopic resection
Laparoscopic abdominoperineal resection

Active Comparator: Open Surgery
patients with low rectal cancer receiving open abdominoperineal resection.
Procedure: Open surgery
Open abdominoperineal resection




Primary Outcome Measures :
  1. operative complications [ Time Frame: 30 days post operatively ]
    intra, and postoperative complications related to operation


Secondary Outcome Measures :
  1. operative mortality [ Time Frame: 30 days post operatively ]
    death occurred 30 days after operation

  2. disease-free survival [ Time Frame: 3 years ]
    disease-free survival rate at 3 years after operation

  3. overall survival [ Time Frame: 3 and 5 years ]
    overall survival rate at 3 and 5 years after operation

  4. locoregional recurrence rate [ Time Frame: 3 and 5 years ]
    local recurrence rate at 3 and 5 years after operation


Other Outcome Measures:
  1. operative time [ Time Frame: Day 1 ]
  2. rate of conversion to open surgery [ Time Frame: Day 1 ]
  3. estimated blood loss [ Time Frame: Day 1 ]
    Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.

  4. circumferential resection margin [ Time Frame: 10 days post operatively ]
    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.

  5. proximal/distal resection margin [ Time Frame: 10 days post operatively ]
    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.

  6. number of retrieved lymph nodes [ Time Frame: 10 days post operatively ]
    It will be reported according to the post-operative pathology.

  7. postoperative hospital stay [ Time Frame: 30 days post operatively ]
    The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.

  8. self reported bladder function [ Time Frame: at postoperative 3, 6 and 1 2 months ]
    This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)

  9. self reported sexual function for male patients [ Time Frame: at postoperative 3, 6 and 1 2 months ]
    This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).

  10. self reported sexual function for female patients [ Time Frame: at postoperative 3, 6 and 1 2 months ]
    This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, laparoscopic and open 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985698


Contacts
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Contact: Jianmin Xu, MD +86-13501984869 xujmin@aiiyun.com

Locations
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China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Principal Investigator: Jianmin Xu, MD         
Sponsors and Collaborators
Fudan University
Investigators
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Study Chair: Jianmin Xu, MD Fudan University

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Responsible Party: Xu jianmin, Prof., Fudan University
ClinicalTrials.gov Identifier: NCT01985698     History of Changes
Other Study ID Numbers: RLOAPR
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Keywords provided by Xu jianmin, Fudan University:
Low rectal cancer
Robotic
Laparoscopic
Abdominoperineal resection
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases