Rectal Cancer
Conditions
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 . .
Interventions
* 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
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative complication | 1 day | complication occured intraoperatively or on the first day of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | 1 years | rate of death |
| morbidity rate | 1 year | rate of postoperative morbidity |
| recurrance rate | 2 years | rate of local recurance( by CT scan ) |
| resection margin | 1 years | circumferential resection margin microscopic examination |
| Sexual functional outcomes | 2 years | sexual function with IIEF(International Index of Erectile Function) questionnaire |
| Mesorectal completeness | 1 year | The quality of the mesorectum or TME specimen(pathological examination) |
| Anorectal function outcomes | 2 years | manometric assessment of anorectal function |
Countries
Egypt
Contacts
Primary Contactmohamed abulfetouh, MD
Outcome results
None listed