A Clinical Trial to Eveluate the Efficacy and Safety of Anti-adhesive Agent INTERGUARD® in Abdominal Surgery

A Prospective, Singlecenter, Open, Comparative, Pilot Trial to Evaluate the Efficacy and Safety of INTERGUARD® in Prevention of Adhesion during Enterostomy and Stoma take-down

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005062

Enrollment

Registered

2020-05-27

Start date

2019-05-05

Completion date

Unknown

Last updated

2020-06-15

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 : For the experimental group, use the anti-adhesion agent INTERGUARD for the enterostomy. INTERGUARD is a sheet type which length and width is 7.5cm, 10cm. Use 1 or 2 sheets per subject

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Experimental group: Inclusion Criteria 1) Over 19 years of age 2) Scheduled to be operated enterostomy and stoma take-down and use anti-adhesion agent 3) Agree to follow the instruction and sign up with Informed Consent Form Control group: Inclusion Criteria 1) Over 19 years of age 2) Satisfy one of the following two cases: - Scheduled to be operated enterostomy and stoma take-down without using anti-adhesion agent -A person who is scheduled to take-down after enterostomy and who is not planning to use anti-adhesion agent during the bowel construction procedure 3) A person who voluntarily decides to participate in this clinical trial and is willing to comply with the clinical trial plan.

Exclusion criteria

Exclusion criteria: 1) History of laparotomy through incision or adhesion around incision site 2) Presence of intraperitoneal Infection such as peritonitis or intraabdominal abscess 3) A person who continuously administered more than 20 mg/day of Corticosteroids within 30 days prior to surgery 4) Presence of blood coagulation dysfunction 5) In case the immune function is degraded enough to affect the course of surgery or postoperative progress 6) A women who is pregnant or breastfeeding or have plans for pregnancy 7) Patient who will not suitable for the study judged by investigator * Specific reasons are recorded in the CRF.

Design outcomes

Primary

Measure	Time frame
Evaluated intra-abdominal adhesion grade of abdominal quadrant by independent evalutor	—

Secondary

Measure	Time frame
Occurance of small-bowel obstruction;Occurance of ileus;Abnormal laboratory values and urine analysis values;Complications or adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactBOMI SEO

Gachon University Gil Medical Center

Outcome results