Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision

• Registration Number: NCT03171298
• Lead Sponsor: Assiut University

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 .

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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-20
• Study First Submitted QC: 2017-05-28
• Last Update Submitted: 2017-05-28
• Study First Posted: 2017-05-31
• Last Update Posted: 2017-05-31
• Study Start: 2017-06-01
• Primary Completion: 2019-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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 .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transanal TME	Laparoscopic Assisted Transanal Total Mesorectal Excision	Laparoscopic Assisted Transanal Total Mesorectal Excision

Primary Outcome Measures

Name	Time	Method
intraoperative complication	1 day	complication occured intraoperatively or on the first day of surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assuit Universty Hospital; 🇪🇬 Assiut, Egypt