ReAL Trial (Rectal Anastomotic seaL) (ReAL)

October 19, 2020 updated by: Societa Italiana di Chirurgia ColoRettale

Prevention of Anastomotic Leak in Colorectal Surgery by Glue Reinforcement. A Prospective Randomized Trial.

The problem of anastomotic leak is particularly relevant in rectal surgery. Many risk factors have been recognized in the onset of this complication. Preventing the anastomotic leak can bring benefits to the patient and the health system.

Several attempts have been proposed to reduce the risk of anastomotic leakage in rectal cancer surgery including suture protection with omental flap and external suture reinforcement by biological glue or mesh.

Cyanoacrylate (Glubran 2®) is a synthetic glue with sealing, adhesive and hemostatic properties widely used in surgery. The sealing effect creates an antiseptic barrier against bacteria.

The hypothesis is that the application of nebulized cyanoacrylate to the colo-rectal anastomosis in open or laparoscopic/robotic rectal surgery can prevent the leakage

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer (CRC) is the second most common cause of cancer-related death in male and the third in females in Western Countries accounting for more than 500,000 deaths in 2013 worldwide.

One of the most worrying postoperative complication in colorectal surgery is the anastomotic leak which can occur in about 10-15% of the cases.

This complication severely impact clinical outcomes with increased risk of death or permanent stoma, higher risk of local recurrence) and relevant increase in hospital costs (length of hospital stay, admission to intensive care, re-interventions).

The problem of anastomotic leak is particularly relevant in rectal surgery. The more distal the anastomosis, the higher the likelihood of failure, with resection of a distal rectal cancer having almost a five-fold increased risk of anastomotic leak compared with resection for colon cancer.

In fact, anastomotic Leakage (AL) is the most severe complication after Low anterior resection of rectum for cancer, occurring between 3 and 24 % of patients.

Many risk factors have been recognized in the onset of this complication, including gender (male patient have a higher anastomotic leak rate), malnutrition, obesity an diabet, american society anesthesiologists (ASA) score, tobacco use, cardiovascular disease, immunosuppression, use of NSAID, preoperative pelvis radiation.

Other intraoperative risk factors considered are the splenic flexure mobilization with proximal ligation of the inferior mesenteric artery (IMA), positive intraoperative Air-Leak Test and the perfusion of the anastomosis.

Temporary fecal diversion has also been suggested (although a diverting stoma mitigates the clinical consequences of an anastomotic leak but does not prevent it.

Other intraoperative technical factors include the use of single or double stapled anastomotic techniques, with or without transanal reinforcing sutures.

Therefore, preventing the anastomotic leak can bring benefits to the patient and the health system.

All the risk factors described above represent the rationale that justifies the use of intraoperative procedures to prevent the anastomotic leak, such as additional manual stiches to the mechanical suture and / or patches of collagen (proper reinforcement or buttressing) or of sealants.

Several attempts have been proposed to reduce the risk of AL in rectal cancer surgery including suture protection with omental flap and external suture reinforcement by biological glue or mesh.

Some Authors have reported good results of reinforcement of the colon anastomosis with cyanoacrylate glue. in a porcine model.

Cyanoacrylate is a synthetic glue with sealing, adhesive and haemostatic properties widely used in surgery. Furthermore the sealing effect creates an antiseptic barrier against bacteria.

Several clinical studies have described the utility of cyanoacrylate glue mainly in vascular surgery, urology and bariatric surgery.

Considering its mechanical, physical, biological properties and its safety, cyanoacrylate glue could facilitate the healing of the colorectal anastomosis reducing leak rate, without negative effects on perfusion.

The hypothesis is that the application of nebulized cyanoacrylate to the colo-rectal anastomosis in open or laparoscopic/robotic rectal surgery can prevent the leakage

Study Type

Interventional

Enrollment (Anticipated)

140

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 Contact

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Dept of Emergency and Organ transplantation - University of Bari

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

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resectable, histologically proven primary adenocarcinoma of the High-medium rectum without internal and/or external sphincter muscle involvement.
  • Distal margin of the tumor at least 8 cm form the anal verge
  • Staged as follows prior to neoadjuvant chemoradiation: Stage T2 - T4 at MRI
  • Patient classified T3-T4 will undergo neoadjuvant chemoradiation if the cancer is located in the extraperitoneal rectum

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 8 cm from the anal verge requiring colo-anal or ultra low rectal anastomosis
  • Recurrent rectal cancer
  • Previous pelvic malignancy
  • Inability to sign the informed consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cyanoacrylate
the anastomotic reinforcement with nebulized cyanoacrylate glue using the special short catheter device for open surgery or the laparoscopic catheter.
Procedure: Cyanoacrylate reinforcement
Anastomosis Reinforcement with with nebulization of 1cc of glue on the anastomosis line
Active Comparator: No reinforcement
No reinforcement will be applied on the anastomosis line
Procedure: No reinforcement
Nothing applied on the anastomosis line

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic leak
Time Frame: 30 days
leakage of the colorectal anastomosis clinically proven or with two sides X-ray
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: 30 days
duration of hospital stay
30 days
Blood loss
Time Frame: 1 day
the amount of bleeding during the operation
1 day
Surgical site infection
Time Frame: 30 days
purulent discharge from the wound with positive culture
30 days
Postoperative complications
Time Frame: 30 days
complications after the operation
30 days

Collaborators and Investigators

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

Sponsor

Societa Italiana di Chirurgia ColoRettale

Investigators

  • Principal Investigator: Donato Altomare, Prof, Societa Italiana di Chirurgia ColoRettale

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

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 (Actual)

May 2, 2019

Primary Completion (Anticipated)

December 2, 2020

Study Completion (Anticipated)

July 2, 2021

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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