primary rectal cancer rectal cancer
Conditions
Interventions
Application of the anti-adhesion barrier
anti-adhesion
Sponsors
Horii Yoshihiro
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with initial and primary rectal cancer. 2) Patients with cStage 0 to cStage III. 3) Patients who are scheduled to undergo laparoscopic rectal resection and temporal colostomy. 4) Patients who are scheduled to undergo the closure of artificial anus at 8 to 48 weeks after initial surgery.
Exclusion criteria
Exclusion criteria: Pre-operation: 1) Patients who are scheduled to undergo open abdominal surgery. 2) Patients who had a history of intraperitoneal surgery except for appendicitis, Caesarean section, or laparoscopic cholecystectomy. 3) Patients who are scheduled to remove specimens from the site other than the midline incision (except in the case of robotic surgery). 4) Patients whose performance Status >=3. 5) Patients with 35 or higher of BMI. During Operation: 1) Patients who need to undergo open abdominal surgery during laparoscopic procedure. 2) Patients who did not have a temporary colostomy. 3) Patients whose specimen was removed from a site other than the midline wound (except in the case of robotic surgery). 4) Patients who underwent colostomy at the umbilical site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| presence/absence of adhesion | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Severity score of adhesion Range score of adhesion Presence/absence of ileus Success rate of pasting Safety: Adverse event, device failure or malfunction hematologic tests, blood biochemical tests vital signs | — |
Contacts
Public ContactYoshihiro Horii
Cytori Therapeutics K.K.
Outcome results
None listed