Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Rectal Cancer Clinical Trial

Official title:

Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03171298
• Other study ID #: transanal surgical approach
• Status: Not yet recruiting
• Phase: N/A
• First received: May 20, 2017
• Last updated: May 28, 2017
• Start date: June 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: mohamed abulfetouh, MD
• Phone: 0201098904323
• Email: m.abulfetouh[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	Assuit Universty Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative complication	complication occured intraoperatively or on the first day of surgery	1 day
Secondary	resection margin	circumferential resection margin microscopic examination	1 years
Secondary	Mortality rate	rate of death	1 years
Secondary	morbidity rate	rate of postoperative morbidity	1 year
Secondary	recurrance rate	rate of local recurance( by CT scan )	2 years
Secondary	Anorectal function outcomes	manometric assessment of anorectal function	2 years
Secondary	Sexual functional outcomes	sexual function with IIEF(International Index of Erectile Function) questionnaire	2 years
Secondary	Mesorectal completeness	The quality of the mesorectum or TME specimen(pathological examination)	1 year