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Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

NCT ID: NCT03171298

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-03-31

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 .

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transanal TME

Laparoscopic Assisted Transanal Total Mesorectal Excision

Group Type EXPERIMENTAL

Laparoscopic Assisted Transanal Total Mesorectal Excision

Intervention Type PROCEDURE

* 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

Interventions

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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

Intervention Type PROCEDURE

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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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mohamed abulfetouh

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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samir a ali, phd

Role: STUDY_DIRECTOR

assuit university hospital

Locations

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Assuit Universty Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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mohamed abulfetouh, MD

Role: CONTACT

Phone: 0201098904323

Email: [email protected]

Facility Contacts

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samir a ali, PHD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26310534 (View on PubMed)

Other Identifiers

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transanal surgical approach

Identifier Type: -

Identifier Source: org_study_id