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Clinical Trials/NCT03171298
NCT03171298
Unknown
Not Applicable

Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Assiut University1 site in 1 country100 target enrollmentJune 1, 2017
ConditionsRectal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Assiut University
Enrollment
100
Locations
1
Primary Endpoint
intraoperative complication
Last Updated
8 years ago

Overview

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 . .

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
March 31, 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mohamed abulfetouh

Principal investigator

Assiut University

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,

Outcomes

Primary Outcomes

intraoperative complication

Time Frame: 1 day

complication occured intraoperatively or on the first day of surgery

Secondary Outcomes

  • resection margin(1 years)
  • morbidity rate(1 year)
  • Mesorectal completeness(1 year)
  • Mortality rate(1 years)
  • Sexual functional outcomes(2 years)
  • recurrance rate(2 years)
  • Anorectal function outcomes(2 years)

Study Sites (1)

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