. 2017 Jul 25;21(10):1683–1691. doi: 10.1007/s11605-017-3503-1

Table 3.

Inclusion and exclusion criteria for the trial

Inclusion criteria	Exclusion criteria
1. Patients scheduled to undergo the initial surgery, and to undergo the second-look surgery 3 to 6 months after the initial surgery 2. Patients able to undergo the first- and second-look surgeries under general anesthesia 3. Patients indicated for laparotomy 4. Patients with ECOG performance status of 0 or 1 5. Patients aged 20 years or older at the time the consent form is signed 6. Patients able to undergo all scheduled observations and who consented to all details of the observations 7. Patients able to comply sufficiently with the procedures and regulations in the study 8. Patients able to freely provide written informed consent to participate in the study using the consent form approved by the IRB of each site	1. A history of hypersensitivity to substances derived from corn starch 2. Patients with active cancer other than rectal cancer 3. A history of radiotherapy in the abdominal cavity or pelvic cavity 4. A history of surgery in the abdominal cavity or pelvic cavity accompanied by a laparotomy scar (excluding surgery for appendicitis) 5. Patients with peritonitis 6. Patients subject to emergency surgery 7. Patients with severe diabetes or abnormal glucose metabolism 8. Patients with glycogenosis 9. Patients with serious liver disorder 10. Patients with serious renal disorder 11. Patients with a BMI of >30 12. Patients for whom chronic corticosteroid treatment is necessary 13. Patients scheduled for another laparotomy in the period between the initial surgery and second-look surgery 14. Laparoscopic assessment of adhesions may not be performed safely at the second-look surgery 15. Patients who participated in other clinical studies within 6 months prior to the day of signing the consent form, or patients who are currently participating in other clinical studies 16. Pregnant or lactating patients 17. Patients that the investigator or sub-investigator consider inappropriate for inclusion in the study as they have tested positive for infections, such as hepatitis B virus, hepatitis C virus, and human immunodeficiency virus 18. Patients with medical conditions that may hinder the safety or efficacy evaluation of the study device 19. Patients the investigator or sub-investigator considered inappropriate for inclusion in the study for any other reason

Inclusion criteria

Exclusion criteria

1. Patients scheduled to undergo the initial surgery, and to undergo the second-look surgery 3 to 6 months after the initial surgery
2. Patients able to undergo the first- and second-look surgeries under general anesthesia
3. Patients indicated for laparotomy
4. Patients with ECOG performance status of 0 or 1
5. Patients aged 20 years or older at the time the consent form is signed
6. Patients able to undergo all scheduled observations and who consented to all details of the observations
7. Patients able to comply sufficiently with the procedures and regulations in the study
8. Patients able to freely provide written informed consent to participate in the study using the consent form approved by the IRB of each site

1. A history of hypersensitivity to substances derived from corn starch
2. Patients with active cancer other than rectal cancer
3. A history of radiotherapy in the abdominal cavity or pelvic cavity
4. A history of surgery in the abdominal cavity or pelvic cavity accompanied by a laparotomy scar (excluding surgery for appendicitis)
5. Patients with peritonitis
6. Patients subject to emergency surgery
7. Patients with severe diabetes or abnormal glucose metabolism
8. Patients with glycogenosis
9. Patients with serious liver disorder
10. Patients with serious renal disorder
11. Patients with a BMI of >30
12. Patients for whom chronic corticosteroid treatment is necessary
13. Patients scheduled for another laparotomy in the period between the initial surgery and second-look surgery
14. Laparoscopic assessment of adhesions may not be performed safely at the second-look surgery
15. Patients who participated in other clinical studies within 6 months prior to the day of signing the consent form, or patients who are currently participating in other clinical studies
16. Pregnant or lactating patients
17. Patients that the investigator or sub-investigator consider inappropriate for inclusion in the study as they have tested positive for infections, such as hepatitis B virus, hepatitis C virus, and human immunodeficiency virus
18. Patients with medical conditions that may hinder the safety or efficacy evaluation of the study device
19. Patients the investigator or sub-investigator considered inappropriate for inclusion in the study for any other reason