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

Primary Purpose

Anastomotic Leak

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transanal Inspection and management of low ColoRectal Anastomosis
Sponsored by
University of Rome Tor Vergata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anastomotic Leak focused on measuring Anastomotic Leak, Rectal cancer, Double stapling technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rome Tor Vergata

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TICRANT

Arm Description

Transanal Inspection and management of low ColoRectal Anastomosis

Outcomes

Primary Outcome Measures

Incidence of anastomotic leakage after intervention
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.

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2014
Last Updated
October 24, 2017
Sponsor
University of Rome Tor Vergata
Collaborators
San Giuseppe Moscati Hospital, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Casa di Cura San Pio X, Milano, Italy, Policlinico Abano Terme, Ospedale Maggiore, Bologna Italy
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1. Study Identification

Unique Protocol Identification Number
NCT02879370
Brief Title
Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique
Acronym
TICRANT
Official Title
"Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique: the TICRANT Study"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata
Collaborators
San Giuseppe Moscati Hospital, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Casa di Cura San Pio X, Milano, Italy, Policlinico Abano Terme, Ospedale Maggiore, Bologna Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak
Keywords
Anastomotic Leak, Rectal cancer, Double stapling technique

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TICRANT
Arm Type
Experimental
Arm Description
Transanal Inspection and management of low ColoRectal Anastomosis
Intervention Type
Procedure
Intervention Name(s)
Transanal Inspection and management of low ColoRectal Anastomosis
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of anastomotic leakage after intervention
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety margin after tumor resection
Description
postoperative pathology of tumor specimen wiyh asscesment of cancer free both radial and distal margins
Time Frame
1 year
Title
Postoperative morbidities and mortalities
Description
Overall all deaths or complications occurred during the surgery or 30 days postoperative
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Crafa, MD
Organizational Affiliation
San Giuseppe Moscati Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giovanni Romano, MD
Organizational Affiliation
Fondazione G. Pascale
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jacques Megevand, MD
Organizational Affiliation
Pavia University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Rome Tor Vergata
City
Rome
State/Province
RM
ZIP/Postal Code
00133
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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9718009
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Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique

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