Patients scheduled to undergo early second-stage stoma closure following rectal resection and tempor Rectal Neoplasms
Conditions
Interventions
1.Create a subcutaneous pocket by making a small incision along the abdominal midline, then dissecting subdermal tissue towards the left and right to create the pocket.
2.Confirm the space required fo
D003107
Colorectal Surgery
Sponsors
Oda Tatsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with primary rectal cancer, with the distal edge of the tumor located within 10 cm from the anal verge (regardless of whether preoperative treatment has been administered). 2. The anastomotic site is expected to be located within 6 cm from the anal verge. 3. Histological diagnosis of rectal adenocarcinoma or rectal neuroendocrine tumor confirmed by biopsy of the primary rectal lesion. 4. Scheduled to undergo elective surgery. 5. Aged 18 years or older at the time of informed consent. 6. Laboratory values within 30 days prior to enrollment indicate adequate organ function. 7. ECOG Performance Status of 0 or 1. 8. Written informed consent voluntarily provided by the patient for participation in this study. Notes: - Both open and laparoscopic surgeries are acceptable. - No restrictions on the type of reconstruction method. - No restrictions based on clinical stage. - Participation in other clinical trials related to surgical procedures is allowed; however, participation in trials involving investigational
Exclusion criteria
Exclusion criteria: 1.Patients requiring emergency surgery. 2.Cases not intended for curative treatment, where residual cancer cells are expected. 3.Patients receiving dialysis. 4.Patients receiving steroids or immunosuppressive agents. 5.Patients with poorly controlled diabetes mellitus (HbA1c > 7.5% within 30 days prior to enrollment). 6.Patients deemed ineligible for participation in this study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure Completion Rate from BCM1 Implantation to Engraftment at the Target Site Note: The procedure completion is defined as the successful accomplishment of the entire process, including the implantation of the device, formation of the bio-cocktail, removal of the device, intended use of the bio-cocktail, and engraftment into the tissue. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of subjects in whom bio-cocktail tissue was successfully formed. 2.Surface area of bio-cocktail collected. 3.Wound surface area and its reduction rate at the time of device implantation, bio-cocktail tissue filling, and at 4, 6, 8, 10, and 12 weeks after filling. 4.Percentage of subjects whose wounds healed by 4 and 8 weeks after bio-cocktail tissue filling. 5.Wound healing score using the Muchester scur scale at the time of bio-cocktail tissue filling, and at 4, 6, 8, 10, and 12 weeks after filling. 6.Incidence rate of diseases (adverse events). 7.Number of days from bio-cocktail tissue filling to discharge. 8.Colonoscopic findings at 4, 6, 8, 10, and 12 weeks after administration at the anastomosis site. | — |
Contacts
Public ContactDaichi Kitaguchi
University of Tsukuba Hospital
Outcome results
None listed