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Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery

T

The Catholic University of Korea

Status and phase

Unknown
Phase 3

Conditions

Adhesive Intestinal Obstruction

Treatments

Device: GUARDIX-SG

Study type

Interventional

Funder types

Other

Identifiers

NCT02198898
GUARDIXGASTRIC (Other Identifier)
CUMCGC1301

Details and patient eligibility

About

This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea and the investigators hypothesized applying of adhesive preventing agent would reduce incidence of adhesive obstruction after gastrectomy.

Full description

Adhesive bowel obstruction is relatively often complication in patients after abdominal surgery

Gastric cancer is the most frequent cancer in Korea.

The incidence of adhesive bowel obstruction would be increased in patients with gastric cancer, especially associated radical lymphadenectomy.

The causes of postoperative adhesive obstruction include adhesion of the wound, adhesion of small intestine to small intestine, adhesion of the small intestine to other abdominal organs, and internal hernia.

Several studies reported efficacy of adhesive preventing agent after colorectal resection.

Gastrectomy is associated with a high risk (incidence, 11.7%-38.5%) of bowel obstruction.

To date, however, no randomized study has shown that GUARDIX-SGⓇ reduces the rate of small bowel obstruction after gastrectomy with radical lymphadenectomy for gastric cancer.

Enrollment

224 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy
  • Informed consents

Exclusion criteria

  • Pregnant
  • Ascites
  • Liver dysfunction
  • Renal failure
  • Past history of abdominal operation or small bowel obstruction

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

224 participants in 2 patient groups

GUARDIX
No Intervention group
Description:
no guadix
guadix
Experimental group
Description:
guadix treatment
Treatment:
Device: GUARDIX-SG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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