Clinical Trial: Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: "Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique: the TICRANT Study"

Brief Summary: The technique the investigators propose to perform colorectal and colo-anal anastomosis in patients underwent low and ultra-low anterior resection for rectal cancer could potentially reduce the anastomotic leakage rate by better trans-anal introduction of the circular stapler, elimination of the previous suture lines and dog ears, combined with direct inspection of the anastomosis, easy performance of trans-anal air leak tests and eventually direct repair of any small anastomotic defects. Another important point in cancer surgery is the easily identification of the distal margin. In fact, this technique is simple to perform, reproducible and safe in terms of complications.

Detailed Summary:

-Study design Subjects for this study were prospectively enrolled between January 2013 and January 2016 in the participating centers.

All patients signed written informed consent including the possibility of future publication according to the Italian bioethics laws. Institutional Review Board (IRB) approval has been obtained from the local Ethical Committee of each center in compliance with the Principals of Helsinki Declaration.

-Preoperative assessment and preparation All cases were discussed individually on colorectal multidisciplinary meeting with standard preoperative staging for rectal cancer including; colonoscopy with biopsy, CT chest, and abdomen, MRI pelvis and/or endo-rectal ultrasound. All patients were evaluated preoperative by expert anesthesiologists for individual co-morbidity with classification according to the ASA score.

The day before surgery mechanical bowel preparation with 4 liters of PEG (PolyEthilene Glycol) was administered together with liquid diet. An adequate thromboembolic prophylaxis with low molecular weight heparin was given the evening before the surgery. Antibiotic prophylaxis with second generation cephalosporin was administered at induction of anesthesia.

-Surgical technique The low or ultra-low anterior resection with total mesorectal excision (TME) were performed, either open, laparoscopic, robotic. Just before rectal division, the circular anal dilator (CAD) device was introduced into the anal canal and fixed by four 0-silk suture to the perianal skin apply at the 4 cardinal's points. The rectal inspection was carried out by the Purse Suture Anoscope (PSA) to correctly identify the proximal and distal extension of the tumor. After that the rectum was divided by linear or curved staple
Sponsor: University of Rome Tor Vergata

Current Primary Outcome: Incidence of anastomotic leakage after intervention [ Time Frame: 1 year ]

The authors adapted these criteria for diagnosis of anastomotic leakage; fecal material from the drain or the wound, extravasation of dye on contrast enema, anastomotic defect visualized by colonoscopy, or the presence of peri-anastomotic air or fluid visualized by CT scan.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety margin after tumor resection [ Time Frame: 1 year ]
    postoperative pathology of tumor specimen wiyh asscesment of cancer free both radial and distal margins
  • Postoperative morbidities and moralities [ Time Frame: 1 year ]
    Overall all deaths or complications occurred during the surgery or 30 days postoperative


Original Secondary Outcome: Same as current

Information By: University of Rome Tor Vergata

Dates:
Date Received: November 24, 2014
Date Started: January 2013
Date Completion: December 2016
Last Updated: August 20, 2016
Last Verified: August 2016