Patients who need the entire colectomy and are planned to receive the first stage surgery (ileostomy) of two-staged surgery
Conditions
Interventions
Using THN-01 at the first stage surgery
Using placebo at the first stage surgery
Sponsors
Otsuka Pharmaceutical Factory, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who need the entire colectomy due to such as ulcerative colitis or familial polyposis coli (2) Patients who are planned to receive the first stage surgery (ileostomy) of two-staged surgery (3) Patients aged 20 years or older at the time of informed consent (4) Patients who can provide written informed consent
Exclusion criteria
Exclusion criteria: (1) Patients who have a history of intraperitoneal surgery except the surgeries for specific organs such as appendicectomy (2) Patients with peritonitis or a history of it (3) Patients with endometriosis or a history of it (4) Patients with bowel cancer of stage >=II (5) Patients with digestive tract perforation (6) Patients who are pregnant, lactating, or plannig to be pregnant (7) Patients who have been treated with an unapproved medicine or medical device within 16 weeks before the day of informed consent (8) Others who have been determined ineligible by principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of adhesions formed in the abdominal cavity | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Presence/absence of adhesion in the entire abdominal cavity (2)Scores for extent and severity of adhesion in the entire abdominal cavity (3)The number of adhesions formed in the area including small intestine (4)Presence/absence of adhesion in the area including small intestine (5)Scores for extent and severity of adhesion in the area including small intestine (6)The number of adhesions dissected | — |
Countries
Japan
Contacts
Public ContactYoshihiro Kume
Otsuka Pharmaceutical Factory, Inc. Clinical Development Department
Outcome results
None listed