Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Study Overview
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Brief Summary
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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
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This clinical trial will be conducted at general surgery department of Assiut University Hospital . .

Official Title
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Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transanal TME<br>Laparoscopic Assisted Transanal Total Mesorectal Excision | Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative complication | complication occured intraoperatively or on the first day of surgery | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resection margin | circumferential resection margin microscopic examination | 1 years | 
| Mortality rate | rate of death | 1 years | 
| morbidity rate | rate of postoperative morbidity | 1 year | 
| recurrance rate | rate of local recurance( by CT scan ) | 2 years | 
| Anorectal function outcomes | manometric assessment of anorectal function | 2 years | 
| Sexual functional outcomes | sexual function with IIEF(International Index of Erectile Function) questionnaire | 2 years | 
| Mesorectal completeness | The quality of the mesorectum or TME specimen(pathological examination) | 1 year |