Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch.

Adenocarcinoma Colon Clinical Trial

— ANASTOPATCH  

Official title:

Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109105
• Other study ID #: FIS-HEMOPATCH-2018-02
• Status: Recruiting
• Start date: January 15, 2019
• Est. completion date: May 15, 2020

Study information

• Verified date: September 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Juan Carlos Gómez Rosado
• Phone: 955 00 80 00
• Email: juanc.gomez.rosado.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 15, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old.

• Ability to understand and make their own decision to participate in the study.

• Pre-surgery right colon adenocarcinoma pathological diagnosis.

• Patient with a mechanic, intra or extracorporeal ileocolic anastomosis.

Exclusion Criteria:

• Urgent intervention.

• Simultaneous colon cancer.

• M1 pre-surgery staging.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma Colon
• Colonic Neoplasms

Intervention

Other:
• NHS-PEG coated collagen patch
Analysis of the number and seriousness of leaks in the ileocolic anastomosis after using a NHS-PEG coated collagen patch reinforcement.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.	Ileocolic anastomosis leakage existence of evidence and seriousness.	Up to 30 days after the surgery
Secondary	Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.	Percentage of leaks that occur in the ileocolic anastomosis after being reinforced with NHS-PEG coated collagen patch.	Up to 30 days after the surgery
Secondary	Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.	Number and type of complications due to the anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.	Up to 30 days after the surgery
Secondary	Number of surgical repetitions.	Number of following surgeries that the patient has to undergo due to the failure of the collagen patch ileocolic anastomosis protection.	Up to 30 days after the surgery
Secondary	Number of hospital readmissions.	Number of times that the patient has to be rehospitalized due to the failure of the collagen patch ileocolic anastomosis protection.	Up to 30 days after the surgery