Patients with primary rectal cancer who are scheduled to undergo loop ileostomy during laparotomy
Conditions
Interventions
TCD-11091(Adhesion Barrier System)
untreated
Sponsors
Terumo Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients who must meet the eligibility criteria below will be included in the study. For 1) to 4) and 7), the conditions apply at the time of registration. 1) Patients undergoing a proctectomy with a loop ileostomy under laparotomy (initial surgery), and scheduled to undergo a colostomy closure 3 months to 6 months after ileostomy (second-look surgery) 2) Patients who will undergo initial surgery and second-look surgery under general anesthetics 3) Patients who are indicated for a laparotomy 4) ECOG Performance Status is 0 to 1 5) Patients who are aged at least 20 years on the day of signing the consent form 6) Patients who are able to undergo all scheduled observations and consent to all details of the observations 7) Patients who are able to comply sufficiently with the procedures and specifications in the study 8) Written consent can be obtained from the patients of their own free will in regards to participation in the study, using the consent form approved by the IRB of the individual study institutions.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adhesion under the medial incision at the time of colostomy closure | — |
Countries
Japan
Outcome results
None listed