Use of biosynthetic material (MegaDerm) as reinforcing buttress material of anastomotic sites after gastric resection

Prospective multicenter clinical study evaluation of the safety and clinical effectivity of applying MegaDerm(R) to resection and anastomosis for patients with gastric cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002715

Enrollment

100

Registered

2018-03-02

Start date

2015-07-22

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : Patients in the intervention arm receive acellular dermal matrix (MegaDerm) support of the anastomotic site by applying it via the surgical stapler

patients in the control arm receive conventional anastomotic reconstruction without acellular dermal matrix support.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who score 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) performance status scale 2) Patients who score 1, 2, or 3 on the ASA (American Society of Anesthesiology) score 3) Patients who were diagnosed with gastric adenocarcinoma preoperatively with endoscopic biopsy 4) Patients who were deemed fit for gastric resection surgery 5) Patients who were informed of the objective and course of the study and then gave their informed consent by providing their signature on the institutional review board-approved consent form

Exclusion criteria

Exclusion criteria: 1) Patients who developed complications of gastric cancer (e.g. obstruction, perforation) 2) Patients who received neoadjuvant chemotherapy or radiotherapy for the gastric cancer 3) Patients who received surgery or radiation therapy for other cancers in the past five years 4) Vulnerable patients (patients who are incapable of making decisions for themselves, pregnant patients, patients planning pregnancy) 5) Patients who are or were enrolled in another clinical trial in the last six months

Design outcomes

Primary

Measure	Time frame
Number of patients that experienced anastomotic leakage and hemorrhage and the severity of those complications as graded by the Clavien-Dindo classification system.	—

Secondary

Measure	Time frame
Laboratory values that are known to predict anastomotic leakage: C-reactive protein, NUn score;Calculated amount of blood loss using established formulas that employ hemoglobin and hematocrit levels	—

Countries

Korea, Republic of

Contacts

Public ContactWon Jun Kim

Korea University Anam Hospital

wonjun.kim20529@gmail.com+82-2-2286-1240

Outcome results