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.

• Conditions: Adenocarcinoma Colon
• Interventions: Other: NHS-PEG coated collagen patch

• Registration Number: NCT04109105
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Status Verified: 2019-09
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02
• Primary Completion: 2019-12-15
• Study Completion: 2020-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NHS-PEG coated collagen patch cohort	NHS-PEG coated collagen patch	Patients diagnosed of colon adenocarcinoma that have ileocolic anastomosis after undergoing a laparoscopic right hemicolectomy surgery.

Primary Outcome Measures

Name	Time	Method
Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.	Up to 30 days after the surgery	Ileocolic anastomosis leakage existence of evidence and seriousness.

Secondary Outcome Measures

Name	Time	Method
Number of hospital readmissions.	Up to 30 days after the surgery	Number of times that the patient has to be rehospitalized due to the failure of the collagen patch ileocolic anastomosis protection.
Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.	Up to 30 days after the surgery	Number and type of complications due to the anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.	Up to 30 days after the surgery	Percentage of leaks that occur in the ileocolic anastomosis after being reinforced with NHS-PEG coated collagen patch.
Number of surgical repetitions.	Up to 30 days after the surgery	Number of following surgeries that the patient has to undergo due to the failure of the collagen patch ileocolic anastomosis protection.

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain