Clinical trial NCT03171298: Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision
Official title: Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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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Eligibility criteria: 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 .

Primary outcomes:
measure: intraoperative complication
timeFrame: 1 day
Secondary outcomes:
measure: resection margin
timeFrame: 1 years
measure: Mortality rate
timeFrame: 1 years
measure: morbidity rate
timeFrame: 1 year
measure: recurrance rate
timeFrame: 2 years
measure: Anorectal function outcomes
timeFrame: 2 years
measure: Sexual functional outcomes
timeFrame: 2 years
measure: Mesorectal completeness
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit Universty Hospital
Study officials:
affiliation: assuit university hospital
name: samir a ali, phd
role: STUDY_DIRECTOR
References:
citation: 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.