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Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

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ClinicalTrials.gov Identifier: NCT02812628
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Bo Feng, Ruijin Hospital

Brief Summary:
This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT).

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: LAPR Procedure: LAPR-TILT Not Applicable

Detailed Description:
In the field of surgical treatment for low rectal cancer, the traditional APR is trapped by the so-called "surgical waist" and associated oncological problems, whereas the spread of extra-levator abdominoperineal resection (ELAPR) is still hindered by its high risk of wound complications and neurovascular injuries. Owing to the advancement of laparoscopic techniques, the investigators developed a laparoscopic APR with TILT procedure. During the procedure, a controlled incision of levators into the ischiorectal fat was performed transabdominally under direct vision; the meeting plane is therefore lowered and the perineal dissection is simplified without changing body position. This technique offers individualized transection of levator muscles, minimizes the risk of wound complications and prevents surgical waist to ensure oncological safety. This clinical trial is designed to evaluate the short-term and long-term benefits of this modified procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer
Study Start Date : December 2012
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Active Comparator: Conventional LAPR
Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).
Procedure: LAPR
Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.

Experimental: LAPR-TILT
Patients undergoing LAPR with transabdominal individualized levator transection (TILT).
Procedure: LAPR-TILT
Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.




Primary Outcome Measures :
  1. 3-year local recurrence [ Time Frame: 3 years post operation ]

Secondary Outcome Measures :
  1. 3-year overall survival [ Time Frame: 3 years post operation ]
  2. 3-year disease-free survival [ Time Frame: 3 years post operation ]

Other Outcome Measures:
  1. Operative time for perineal dissection [ Time Frame: 1 month post operation ]
  2. Numbers of days to remove the urinary catheter after surgery [ Time Frame: 1 month post operation ]
  3. Circumferential Resection Margin (+) rate [ Time Frame: 1 month post operation ]
    circumferential resection margin positive rate

  4. Perforation rate [ Time Frame: 1 month post operation ]
    intraoperative perforation rate



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy.
  2. Patients undergoing elective, radial surgery with no distant metastasis.
  3. Patients with Body Mass Index (BMI) between 18-30kg/m2.
  4. Patients who agree to undergo standard adjuvant treatment after surgery.
  5. Patients who have fully understood the aim of the trial and have signed the written informed consent.

Exclusion Criteria:

  1. Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors.
  2. Patients undergoing emergent surgery.
  3. Pregnant patients.
  4. Patients with tumors other than rectal tumor.
  5. Patients with severe comorbid diseases which preclude surgery.
  6. Patients in bad conditions and do not ameliorate before surgery.
  7. Patients undergoing other procedures to treat rectal cancer, eg. L-Dixon, L-Hartmann or Parks surgery.
  8. Patients who refuse to accept standard adjuvant 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): NCT02812628


Contacts
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Contact: Bo Feng, M.D. Ph.D 86-21-64370045 fengbo2022@163.com

Locations
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China, Shanghai
Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Bo Feng, MD/PhD    86-21-64370045 ext 664566    fengbo2022@163.com   
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Bo Feng, Ph.D Ruijin Hospital
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Responsible Party: Bo Feng, Assistent professor of surgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02812628    
Other Study ID Numbers: MISC-APR
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bo Feng, Ruijin Hospital:
laparoscopic surgery
abdominoperineal resection
rectal cancer
individualized surgery
levator muscle
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases