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Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

A

Assiut University

Status

Unknown

Conditions

Rectal Cancer

Treatments

Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision

Study type

Interventional

Funder types

Other

Identifiers

NCT03171298
transanal surgical approach

Details and patient eligibility

About

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

Full description

This clinical trial will be conducted at general surgery department of Assiut University Hospital .

.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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 .

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

transanal TME
Experimental group
Description:
Laparoscopic Assisted Transanal Total Mesorectal Excision
Treatment:
Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision

Trial contacts and locations

1

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Central trial contact

mohamed abulfetouh, MD

Data sourced from clinicaltrials.gov

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