Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique (TICRANT)

October 24, 2017 updated by: Pierpaolo Sileri, University of Rome Tor Vergata

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

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.

Study Overview

Detailed Description

-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 stapler under CAD direct inspection.

Four 2-0 prolene sutures were trans-anally placed on the rectal stump; 2 of them at the extremities of the suture line (left and right) and the other two 1 cm medially to each of the previous two sutures. Circular stapler was introduced through the CAD (29 or 33 mm KOL stapler, Touchstone International Medical Science Co., Ltd.), the 4 tails of the prolene stitches were introduced through the stapler channels (2 in the left and 2 in the right side of the instrument) and gently pulled in order to obtain a gradual and homogeneous traction of the tissue. After elimination of both previous suture lines and dog ears, then the stapler was fired.

The rectal anastomosis was carefully inspected trans-anally then tested intraoperatively by air leak test through trans-anal air insufflation with the pelvis immersed with physiological saline to detect bubbles, and competence of donuts. If the anastomosis was considered safe the need for protective stoma was left to discretion of operating surgeon.

CAD may be removed at the end of the surgery, or left in place for 3-4 days postoperative to provide a safe and fast access for anastomosis inspection as well to reduce the endo-luminal pressure.

  • Postoperative care The postoperative care concise with the standard care for patients who underwent low or ultra-low rectal resection, thromboembolic prophylaxis continued inform of single low molecular weight heparin 5000 IU 8 hours postoperative or according to the risk status of patients. Antibiotics for 3 days postoperative inform of 1 gm 2nd generation cephalosporin. We encourage fast tract surgery inform early feeding and mobilization as described below;

    • 1st POD: removal of the urinary catheter, start mobilization,
    • 2nd POD: start oral fluid,
    • 3rd-4th POD: start semi-solid then solid feeling,
    • 5-6th POD: discharge home (after performing contrast enema or colonoscopy).
  • Definition of anastomotic leak There is no constant definition for anastomotic leak, but we adapted the criteria recently published by Adams and Papagrigoriadis [8]; feculent 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.
  • Patient's fellow-up Patients were followed-up at the outpatient's clinics at one week, two weeks, and at one month postoperative. A further follow-up occurred at time of stoma reversal in patients with diversion in form of colonoscopy to access anastomotic integrity and preoperative anesthetic fitness as usual. Follow-up was continued at twelve months' postoperative by aid of complete colonoscopy.
  • Variables studied and statistical analysis Basic demographic data were recorded including age and sex of patients as well as detailed information on BMI, ASA, stage and distance of the tumor from anal verge, neo-adjuvant chemotherapy, type of surgical approach (open, laparoscopic and robotic procedure), duration of the operation, postoperative hospital stay, postoperative morbidity and mortality. Data were analyzed using excel and SPSS (Statistical Package for Social Science) version 21 programs under Microsoft Windows. Quantitative data were expressed as mean ± SD when possible.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RM
      • Rome, RM, Italy, 00133
        • University of Rome Tor Vergata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing low or ultra-low anterior resection for biopsy proven primary rectal cancer

Exclusion Criteria:

  • Patients younger than 18 years old,
  • pregnant,
  • recurrent disease,
  • cancer less than 4 cm from the anal verge,
  • abdomeno-perineal resection,
  • emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TICRANT
Transanal Inspection and management of low ColoRectal Anastomosis
Low anterior resection with total mesorectal excision (TME), either performed open, laparoscopic or robotic Closure of the rectum with linear or curved stapler with transanal inspection Transanal placement of four 2-0 prolene sutures on the rectal stump, respectively 2 at the extremities of the suture line (left and right) and other two 1 cm medial to each of the previous two sutures Circular stapler is introduced, the 4 tails of the prolene stitches are introduced through the windows (2 in the left and 2 in the right side of the instrument) and gently pulled, to obtain a gradual and homogeneous traction of the tissue and elimination of both previous suture lines and doggy ears, then the stapler is fired The termino-terminal anastomosis is carefully inspected A leak test can be performed (if negative the protective stoma is not performed) An eventual leak can be transanally repaired

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Francesco Crafa, MD, San Giuseppe Moscati Hospital
  • Study Chair: Giovanni Romano, MD, Fondazione G. Pascale
  • Study Chair: Jacques Megevand, MD, Pavia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

August 20, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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