Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

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

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision

Detailed Description

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

.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assuit Universty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: transanal TME; Laparoscopic Assisted Transanal Total Mesorectal Excision

Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: samir a ali, phd, Assuit University Hospital

Publications and helpful links

General Publications

• Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2017
• Primary Completion (ANTICIPATED): March 31, 2019
• Study Completion (ANTICIPATED): March 31, 2020

Study Registration Dates

• First Submitted: May 20, 2017
• First Submitted That Met QC Criteria: May 28, 2017
• First Posted (ACTUAL): May 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 28, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: transanal surgical approach

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No