NCT03941938

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
Last Updated

October 20, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

May 6, 2019

Last Update Submit

October 19, 2020

Conditions

Rectal Cancer

Keywords

colorectal anastomosisleakage

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leak

    leakage of the colorectal anastomosis clinically proven or with two sides X-ray

    30 days

Secondary Outcomes (4)

  • length of hospital stay

    30 days

  • Blood loss

    1 day

  • Surgical site infection

    30 days

  • Postoperative complications

    30 days

Study Arms (2)

Cyanoacrylate

EXPERIMENTAL

the anastomotic reinforcement with nebulized cyanoacrylate glue using the special short catheter device for open surgery or the laparoscopic catheter.

Procedure: Cyanoacrylate reinforcement

No reinforcement

ACTIVE COMPARATOR

No reinforcement will be applied on the anastomosis line

Procedure: No reinforcement

Interventions

Cyanoacrylate reinforcementPROCEDURE

Anastomosis Reinforcement with with nebulization of 1cc of glue on the anastomosis line

Cyanoacrylate
No reinforcementPROCEDURE

Nothing applied on the anastomosis line

No reinforcement

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Emergency and Organ transplantation - University of Bari

Bari, 70124, Italy

RECRUITING

Related Publications (7)

  • Thomas MS, Margolin DA. Management of Colorectal Anastomotic Leak. Clin Colon Rectal Surg. 2016 Jun;29(2):138-44. doi: 10.1055/s-0036-1580630.

    PMID: 27247539RESULT

  • de la Portilla F, Zbar AP, Rada R, Vega J, Cisneros N, Maldonado VH, Utrera A, Espinosa E. Bioabsorbable staple-line reinforcement to reduce staple-line bleeding in the transection of mesenteric vessels during laparoscopic colorectal resection: a pilot study. Tech Coloproctol. 2006 Dec;10(4):335-8. doi: 10.1007/s10151-006-0303-0. Epub 2006 Nov 27.

    PMID: 17115313RESULT

  • Wiggins T, Markar SR, Arya S, Hanna GB. Anastomotic reinforcement with omentoplasty following gastrointestinal anastomosis: A systematic review and meta-analysis. Surg Oncol. 2015 Sep;24(3):181-6. doi: 10.1016/j.suronc.2015.06.011. Epub 2015 Jun 17.

    PMID: 26116395RESULT

  • Boersema GSA, Vennix S, Wu Z, Te Lintel Hekkert M, Duncker DGM, Lam KH, Menon AG, Kleinrensink GJ, Lange JF. Reinforcement of the colon anastomosis with cyanoacrylate glue: a porcine model. J Surg Res. 2017 Sep;217:84-91. doi: 10.1016/j.jss.2017.05.001. Epub 2017 May 10.

    PMID: 28595813RESULT

  • Montanaro L, Arciola CR, Cenni E, Ciapetti G, Savioli F, Filippini F, Barsanti LA. Cytotoxicity, blood compatibility and antimicrobial activity of two cyanoacrylate glues for surgical use. Biomaterials. 2001 Jan;22(1):59-66. doi: 10.1016/s0142-9612(00)00163-0.

    PMID: 11085384RESULT

  • Wu Z, Boersema GS, Vakalopoulos KA, Daams F, Sparreboom CL, Kleinrensink GJ, Jeekel J, Lange JF. Critical analysis of cyanoacrylate in intestinal and colorectal anastomosis. J Biomed Mater Res B Appl Biomater. 2014 Apr;102(3):635-42. doi: 10.1002/jbm.b.33039. Epub 2013 Oct 24.

    PMID: 24155114RESULT

  • Tomasicchio G, Martines G, Tartaglia N, Buonfantino M, Restini E, Carlucci B, Giove C, Dezi A, Ranieri C, Logrieco G, Vincenti L, Ambrosi A, Altomare DF, De Fazio M, Picciariello A. Suture reinforcement using a modified cyanoacrylate glue to prevent anastomotic leak in colorectal surgery: a prospective multicentre randomized trial : The Rectal Anastomotic seaL (ReAL) trial. Tech Coloproctol. 2024 Aug 5;28(1):95. doi: 10.1007/s10151-024-02967-7.

    PMID: 39103661DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Donato Altomare, Prof

    Societa Italiana di Chirurgia ColoRettale

    PRINCIPAL INVESTIGATOR

  • Arcangelo Picciariello, MD

    Societa Italiana di Chirurgia ColoRettale

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donato Altomare, MD

CONTACT

+39 3397593066donatofrancesco.altomare@uniba.it

Arcangelo Picciariello, MD

CONTACT

+393492185104arcangelopicciariello@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 8, 2019

Study Start

May 2, 2019

Primary Completion

December 2, 2020

Study Completion

July 2, 2021

Last Updated

October 20, 2020

Record last verified: 2020-05

Locations

IT(1)