Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer (ELAPE)
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conventional ELAPE
Individual ELAPE
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Advanced Lower rectal cancer, Extralevator abdominoperineal excision, Circumferential resection margin, Morbidity, Survival
Eligibility Criteria
Inclusion Criteria:
- Tumor within 5 cm of the anal verge or with a very narrow pelvis
- T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination
- Absence of distant metastases
- Absence of intestinal obstruction
Exclusion Criteria:
- T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination
- With distant metastases
- With intestinal obstruction
- Pregnancy or lactation
- Allergic constitution to heterogeneous protein
- With operation contraindication
Sites / Locations
- Beijing Chaoyang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Individual ELAPE
Conventional ELAPE
Arm Description
Patients will receive Individual ELAPE technique
Patients with advanced lower rectal cancer will receive conventional EALPE technique
Outcomes
Primary Outcome Measures
The perioperative morbidity
Sexual dysfunction,Urinary retention,Chronic perineal pain,Perineal wound infection,Urinary system infection,Pulmonary infection,Perineal seroma,Peristomal hernia,Abdominal wound infection,Perineal herniation
Secondary Outcome Measures
Three years survival postoperatively
Full Information
NCT ID
NCT02036112
First Posted
November 26, 2013
Last Updated
January 12, 2014
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02036112
Brief Title
Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer
Acronym
ELAPE
Official Title
Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.
Detailed Description
We suppose that the ELAPE technique may be performed according to individual conditions. For the rectal tumors suitable for ELAPE, most of them were circular or nearly circular infiltrating tumors. Patients with these rectal tumors should receive full ELAPE resection. In those rectal tumors not involving the levator ani muscle, the dissection plane may continue close to the external anal sphincter and the levator ani muscle, leaving the ischioanal fat and the terminal branches of the pudendal nerve intact.If the tumor has only penetrated into 1 side of the levator ani muscle, the dissection might include the levator ani muscle and the fat of the ischioanal fossa on the side of the tumor to achieve a clear circumferential resection margin, whereas the ischioanal fat and levator ani muscle on the other side of the tumor may be left
. This individual ELAPE may be as effective as conventional ELAPE while minimizing the operative trauma and the damage to the nerves of the genital organs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Advanced Lower rectal cancer, Extralevator abdominoperineal excision, Circumferential resection margin, Morbidity, Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individual ELAPE
Arm Type
Experimental
Arm Description
Patients will receive Individual ELAPE technique
Arm Title
Conventional ELAPE
Arm Type
Experimental
Arm Description
Patients with advanced lower rectal cancer will receive conventional EALPE technique
Intervention Type
Procedure
Intervention Name(s)
conventional ELAPE
Intervention Description
device
Intervention Type
Procedure
Intervention Name(s)
Individual ELAPE
Intervention Description
device
Primary Outcome Measure Information:
Title
The perioperative morbidity
Description
Sexual dysfunction,Urinary retention,Chronic perineal pain,Perineal wound infection,Urinary system infection,Pulmonary infection,Perineal seroma,Peristomal hernia,Abdominal wound infection,Perineal herniation
Time Frame
three years
Secondary Outcome Measure Information:
Title
Three years survival postoperatively
Time Frame
three years
Other Pre-specified Outcome Measures:
Title
Three years local recurrence postoperatively
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tumor within 5 cm of the anal verge or with a very narrow pelvis
T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination
Absence of distant metastases
Absence of intestinal obstruction
Exclusion Criteria:
T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination
With distant metastases
With intestinal obstruction
Pregnancy or lactation
Allergic constitution to heterogeneous protein
With operation contraindication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiagang Han, Professor
Phone
8613522867841
Email
hjg211@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiagang Han, Professor
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiagang Han, Professor
Phone
8613522867841
Email
hjg211@163.com
First Name & Middle Initial & Last Name & Degree
Jiagang Han, Professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
22920402
Citation
Han JG, Wang ZJ, Wei GH, Gao ZG, Yang Y, Zhao BC. Randomized clinical trial of conventional versus cylindrical abdominoperineal resection for locally advanced lower rectal cancer. Am J Surg. 2012 Sep;204(3):274-82. doi: 10.1016/j.amjsurg.2012.05.001.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/m/pubmed/22920402/
Description
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Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer
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