NCT03171298

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

May 20, 2017

Last Update Submit

May 28, 2017

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • intraoperative complication

    complication occured intraoperatively or on the first day of surgery

    1 day

Secondary Outcomes (7)

  • resection margin

    1 years

  • Mortality rate

    1 years

  • morbidity rate

    1 year

  • recurrance rate

    2 years

  • Anorectal function outcomes

    2 years

  • +2 more secondary outcomes

Study Arms (1)

transanal TME

EXPERIMENTAL

Laparoscopic Assisted Transanal Total Mesorectal Excision

Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision

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

transanal TME

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit Universty Hospital

Asyut, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 26310534BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • samir a ali, phd

    assuit university hospital

    STUDY DIRECTOR

Central Study Contacts

mohamed abulfetouh, MD

CONTACT

0201098904323m.abulfetouh@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 20, 2017

First Posted

May 31, 2017

Study Start

June 1, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2020

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)