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Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic Assisted Transanal Total Mesorectal Excision
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • rectal cancer histologically proven through biopsy

    • tumours located at least 3 cm from anorectal ring;
    • local spread restricted to the rectal wall
    • adequate preoperative sphincter function and continence;
    • absence of distant metastases.
    • Suitable for elective surgical resection

Exclusion Criteria:

  • • T4 tumours not responding to neoadjuvant chemo- radiotherapy

    • Patients under 18 years of age
    • Pregnancy
    • Previous rectal surgery (except local excision, endoscopic mucosal resection (EMR) or polypectomy)
    • Patients with acute intestinal obstruction
    • Multiple colorectal tumours
    • Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), Crohn's disease or ulcerative colitis
    • Planned synchronous abdominal organ resections
    • Preoperative evidence for distant metastases through imaging of the thorax and abdomen
    • Absolute contraindications to general anaesthesia,
    • presence of fecal incontinence,
    • undifferentiated tumors .

Sites / Locations

  • Assuit Universty Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transanal TME

Arm Description

Laparoscopic Assisted Transanal Total Mesorectal Excision

Outcomes

Primary Outcome Measures

intraoperative complication
complication occured intraoperatively or on the first day of surgery

Secondary Outcome Measures

resection margin
circumferential resection margin microscopic examination
Mortality rate
rate of death
morbidity rate
rate of postoperative morbidity
recurrance rate
rate of local recurance( by CT scan )
Anorectal function outcomes
manometric assessment of anorectal function
Sexual functional outcomes
sexual function with IIEF(International Index of Erectile Function) questionnaire
Mesorectal completeness
The quality of the mesorectum or TME specimen(pathological examination)

Full Information

First Posted
May 20, 2017
Last Updated
May 28, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03171298
Brief Title
Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision
Official Title
Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Rectal cancer is one of the frequent malignant neoplasms ,Total mesorectal excision (TME) has become the gold standard treatment for middle and lower rectal cancers. Laparoscopic TME still be difficult in patients with low rectal tumors, narrow pelvic anatomy, male sex or high body mass index . Difficult visualization of the pelvic anatomy along with the limitation of rigid laparoscopic instruments may affect the quality of oncological outcomes and increase the risks of injuries during surgery. A down to up approach via transanal total mesorectal excision (TaTME) technique may overcome these problems
Detailed Description
This clinical trial will be conducted at general surgery department of Assiut University Hospital . .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transanal TME
Arm Type
Experimental
Arm Description
Laparoscopic Assisted Transanal Total Mesorectal Excision
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Assisted Transanal Total Mesorectal Excision
Intervention Description
Abdominal approach with laparoscopic mobilization of the left colon Laparoscopic isolation and transection of inferior mesenteric vessels . Transabdominal dissection of the upper rectum and mesorectam. Insertion of transanal platform and the creation of pneumorectum. Occlusion of rectum 2 cm distal to the rectal lesion via purse string. Transanal dissection of lower and mid mesorectam The specimen will be extracted transanally
Primary Outcome Measure Information:
Title
intraoperative complication
Description
complication occured intraoperatively or on the first day of surgery
Time Frame
1 day
Secondary Outcome Measure Information:
Title
resection margin
Description
circumferential resection margin microscopic examination
Time Frame
1 years
Title
Mortality rate
Description
rate of death
Time Frame
1 years
Title
morbidity rate
Description
rate of postoperative morbidity
Time Frame
1 year
Title
recurrance rate
Description
rate of local recurance( by CT scan )
Time Frame
2 years
Title
Anorectal function outcomes
Description
manometric assessment of anorectal function
Time Frame
2 years
Title
Sexual functional outcomes
Description
sexual function with IIEF(International Index of Erectile Function) questionnaire
Time Frame
2 years
Title
Mesorectal completeness
Description
The quality of the mesorectum or TME specimen(pathological examination)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • rectal cancer histologically proven through biopsy tumours located at least 3 cm from anorectal ring; local spread restricted to the rectal wall adequate preoperative sphincter function and continence; absence of distant metastases. Suitable for elective surgical resection Exclusion Criteria: • T4 tumours not responding to neoadjuvant chemo- radiotherapy Patients under 18 years of age Pregnancy Previous rectal surgery (except local excision, endoscopic mucosal resection (EMR) or polypectomy) Patients with acute intestinal obstruction Multiple colorectal tumours Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), Crohn's disease or ulcerative colitis Planned synchronous abdominal organ resections Preoperative evidence for distant metastases through imaging of the thorax and abdomen Absolute contraindications to general anaesthesia, presence of fecal incontinence, undifferentiated tumors .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed abulfetouh, MD
Phone
0201098904323
Email
m.abulfetouh@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
samir a ali, phd
Organizational Affiliation
assuit university hospital
Official's Role
Study Director
Facility Information:
Facility Name
Assuit Universty Hospital
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
samir a ali, PHD
Phone
02088403255
Email
samir.ali@med.au.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26310534
Citation
Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27.
Results Reference
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Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

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