Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Assiut University100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Rectal Cancer

Interventions

Laparoscopic Assisted Transanal Total Mesorectal ExcisionPROCEDURE

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 .

Locations (1)

Assuit Universty Hospital

Asyut, Egypt

Outcomes

Primary Outcomes

intraoperative complication

complication occured intraoperatively or on the first day of surgery

Time frame: 1 day

Secondary Outcomes

resection margin

circumferential resection margin microscopic examination

Time frame: 1 years

Mortality rate

rate of death

Time frame: 1 years

morbidity rate

rate of postoperative morbidity

Time frame: 1 year

recurrance rate

rate of local recurance( by CT scan )

Time frame: 2 years

Anorectal function outcomes

manometric assessment of anorectal function

Time frame: 2 years

Sexual functional outcomes

sexual function with IIEF(International Index of Erectile Function) questionnaire

Time frame: 2 years

Mesorectal completeness

The quality of the mesorectum or TME specimen(pathological examination)

Time frame: 1 year

Central Contacts

mohamed abulfetouh, MD

CONTACT

0201098904323 m.abulfetouh@aun.edu.eg

Data from ClinicalTrials.gov

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