Multicenter Study of TCD-11091 (Phase III Clinical Study)

Not Applicable

• Conditions: Patients with primary rectal cancer who are scheduled to undergo loop ileostomy during laparotomy

• Registration Number: JPRN-UMIN000010356
• Lead Sponsor: Terumo Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-01
• Study Completion: 2015-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who meet any of the criteria below at the time of enrolment must be excluded from the study. 1) History of hypersensitivity to substances derived from corn starch 2) Patients who have active cancer other than rectal cancer 3) History of radiotherapy in the abdominal cavity or pelvic cavity 4) History of surgery in the abdominal cavity or pelvic cavity that accompanies a laparotomy scar (excluding surgery for appendicitis) 5) Patients who currently have peritonitis 6) Patients who are subject to emergency surgery 7) Patients who have severe diabetes or disorders of carbohydrate metabolism 8) Patients who have glycogenosis 9) Patients who have a serious hepatic disorder 10) Patients who have a serious renal disorder 11) Patients who are significantly obese (BMI>30) 12) Patients who are required to undergo chronic corticosteroid treatment 13) Patients who are scheduled for another laparotomy in the period between initial surgery and second-look surgery 14) There is a possibility that the laparoscopic assessment of adhesion cannot be conducted safely in the second-look surgery 15) Patients who have participated in other clinical studies within 6 months from the date of signing the consent form, or patients who are currently participating in other clinical studies 16) Patients who are pregnant or lactating 17) Patients who have been tested positive for infections considered by the investigator or subinvestigator as inappropriate for study participation, such as hepatitis B virus, hepatitis C virus, and human immunodeficiency virus 18) Patients who meet medical criteria that hinder the safety or efficacy assessment of the investigational device 19) Patients who have been determined as inappropriate for participation in the study by the investigator or subinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adhesion under the medial incision at the time of colostomy closure