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.

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04109105

Acronym

ANASTOPATCH

Enrollment

Registered

2019-09-30

Start date

2019-01-15

Completion date

2020-05-15

Last updated

2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma Colon

Keywords

Colon neoplasia, Ascendant colon, Surgical anastomosis, Anastomotic leak, Collagen, Polyethylene glycol, Hemopatch

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.

Interventions

OTHERNHS-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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
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.
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.

Countries

Spain

Contacts

Primary ContactJuan Carlos Gómez Rosado

juanc.gomez.rosado.sspa@juntadeandalucia.es955 00 80 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026