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.

NCT ID: NCT04109105

Last Updated: 2019-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-05-15

Brief Summary

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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

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Conditions

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Adenocarcinoma Colon

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NHS-PEG coated collagen patch cohort

Patients diagnosed of colon adenocarcinoma that have ileocolic anastomosis after undergoing a laparoscopic right hemicolectomy surgery.

NHS-PEG coated collagen patch

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Hemopatch

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Carlos Gómez Rosado

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Locations

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Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan Carlos Gómez Rosado

Role: CONTACT

955 00 80 00

Facility Contacts

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Juan Carlos Gómez Rosado

Role: primary

955 00 80 00

Other Identifiers

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FIS-HEMOPATCH-2018-02

Identifier Type: -

Identifier Source: org_study_id

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