Rectal Cancer
Conditions
Keywords
colorectal anastomosis, anastomotic leak, ileostomy, complications
Brief summary
Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy
Interventions
PROCEDUREtransanal anastomotic reinforcement
a circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired. Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12.
PROCEDUREprotective ileostomy group
S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.
DEVICEa circular anal dilator (CAD)
Epo Flier, SapiMed SPA, Alessandria, Italy
Sponsors
Donato F Altomare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement. Distal margin of the tumor at least 6 cm form the anal verge Staged as follows prior to neoadjuvant chemoradiation: Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery
Exclusion criteria
* Squamous cell carcinoma * Adenocarcinoma Stage T1, * T4 with one of the following: with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) * Unresectable primary rectal cancer or Inability to complete R0 resection. * Rectal cancer under 6 cm from the anal verge requiring colo-anal anastomosis * Recurrent rectal cancer * Previous pelvic malignancy * Inability to sign informed consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anastomotic leak | 30 postoperative days | anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of the two operations | Intraoperative | the duration in minutes of the two types of operation |
| Number of overall postoperative complications | 30 postoperative days | — |
Countries
Italy
Contacts
Primary ContactDonato F Altomare, MD
Backup ContactMaria Di Lena, MD
Outcome results
None listed