Table 5. Histopathological evaluation of experimental and control animals.
| Planar, site, and group histomorphology data | Inflammation | Neutrophils | Histiocytes | Lymphocytes | Plasma cells | Multinucleated giant cells | Particulates | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||||
| Time point | Group | Treatment | Animal number | Tissue | Site | |||||||
| Day 35 | Group 1 | Vacuum | 52851 | Rectum | NP | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Anastomosis | 1 | 2 | 1 | 2 | 1 | 0 | 0 | 0 | ||||
| 2 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| 3 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | |||||
| 4 | 2 | 1 | 1 | 1 | 0 | 1 | 1 | |||||
| Rectum | ND | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Anastomosis | Mean | 1.50 | 0.75 | 1.25 | 1.00 | 0.00 | 0.25 | 0.25 | ||||
| 52981 | Rectum | NP | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Anastomosis | 1 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | ||||
| 2 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| 3 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| 4 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| Rectum | ND | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Anastomosis | Mean | 1.50 | 1.00 | 1.00 | 1.00 | 0.00 | 0.00 | 0.00 | ||||
| Day 35 | Group 1 | Vacuum | 52982 | Rectum | NP | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Anastomosis | 1 | 2 | 1 | 2 | 1 | 0 | 0 | 0 | ||||
| 2 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| 3 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| 4 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| Rectum | ND | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Anastomosis | Mean | 1.25 | 1.00 | 1.25 | 1.00 | 0.00 | 0.00 | 0.00 | ||||
| 53184 | Rectum | NP | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Anastomosis | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | ||||
| 2 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| 3 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | |||||
| 4 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| Rectum | ND | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Anastomosis | Mean | 1.00 | 0.50 | 1.00 | 1.00 | 0.00 | 0.00 | 0.00 | ||||
| Day 35 Group 1 - Vacuum (n=4) | Mean | 1 31 | 0.81 | 1.13 | 1.00 | 0.00 | 0.06 | 0.06 | ||||
| SD | 0.24 | 0.24 | 0.14 | 0.00 | 0.00 | 0.13 | 0.13 | |||||
| Median | 1.38 | 0.88 | 1.13 | 1.00 | 0.00 | 0.00 | 0.00 | |||||
| Incidence | 100% | 100% | 100% | 100% | 0% | 25% | 25% | |||||
| Day 35 | Group 2 | No Vacuum | 52852 | Rectum | NP | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Anastomosis | 1 | 2 | 2 | 1 | 1 | 0 | 1 | 0 | ||||
| 2 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | |||||
| 3 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | |||||
| 4 | 2 | 2 | 2 | 1 | 0 | 0 | 0 | |||||
| Rectum | ND | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Anastomosis | Mean | 1.50 | 1.50 | 1.25 | 1.00 | 0.00 | 0.75 | 0.00 | ||||
| 52949 | Rectum | NP | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Anastomosis | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | ||||
| 2 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | |||||
| 3 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| 4 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | |||||
| Rectum | ND | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
| Anastomosis | Mean | 1.25 | 1.00 | 1.00 | 1.00 | 0.00 | 0.00 | 0.25 | ||||
| Day 35: Group 2 - No Vacuum (n=2) | Mean SD | 1.38 | 1.25 | 1.13 | 1.00 | 0.00 | 0.38 | 0.13 | ||||
| Median | 0.18 | 0.35 | 0.18 | 0.00 | 0.00 | 0.53 | 0.18 | |||||
| Incidence | 1.38 | 1.25 | 1.13 | 1.00 | 0.00 | 0.38 | 0.13 | |||||
| 100% | 100% | 100% | 100% | 0% | 50% | 50% | ||||||
|
| ||||||||||||
| Planar, site, and group histomorphology data | Micro-abscess | Anastomosis integrity | Tissue proliferation | Necrosis | Fibrosis/capsule formation | Comments/ observations | ||||||
|
| ||||||||||||
| Time point | Group | Treatment | Animal number | Tissue | Site | |||||||
|
| ||||||||||||
| Day 35 | Group 1 | Vacuum | 52851 | Rectum | NP | 0 | NA | 0 | 0 | 0 | None. | |
| Anastomosis | 1 | 0 | 0 | 4 | 0 | 2 | Presence of mucosal glands on the serosal surface with inflammation due to anastomosis procedure. Staples with surrounding inflammation are present. Lymphoid follicles present within submucosa. | |||||
| 2 | 0 | 0 | 4 | 0 | 1 | Staples with surrounding inflammation are present. | ||||||
| 3 | 0 | 0 | 4 | 0 | 2 | Staple with surrounding inflammation is present. | ||||||
| 4 | 0 | 0 | 4 | 0 | 2 | Staple with surrounding inflammation is present. Particulate is surrounded by granulomatous inflammation. | ||||||
| Rectum | ND | 0 | NA | 0 | 0 | 0 | None. | |||||
| Anastomosis | Mean | 0.00 | 0.00 | 4.00 | 0.00 | 1.75 | ||||||
| 52981 | Rectum | NP | 0 | NA | 0 | 0 | 0 | None. | ||||
| Anastomosis | 1 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | |||||
| 2 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| 3 | 0 | 0 | 4 | 0 | 3 | Staples with surrounding inflammation are present. Anastomosis site filled by adipose tissue, fibro-vascular proliferation and inflammation. Lymph node section present on adventitia. |
||||||
| 4 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| Rectum | ND | 0 | NA | 0 | 0 | 0 | None. | |||||
| Anastomosis | Mean | 0.00 | 0.00 | 4.00 | 0.00 | 2.25 | ||||||
| Day 35 | Group 1 | Vacuum | 52982 | Rectum | NP | 0 | NA | 0 | 0 | 0 | None. | |
| Anastomosis | 1 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | |||||
| 2 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. Presence of mucosal glands on the serosal surface with inflammation due to anastomosis procedure. | ||||||
| 3 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. Presence o dilated/cystic mucosal gland/s on the serosal surface with inflammation due to anastomosis procedure. |
||||||
| 4 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| Rectum | ND | 0 | NA | 0 | 0 | 0 | None. | |||||
| Anastomosis | Mean | 0.00 | 0.00 | 4.00 | 0.00 | 2.00 | ||||||
| 53184 | Rectum | NP | 0 | NA | 0 | 0 | 0 | None. | ||||
| Anastomosis | 1 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | |||||
| 2 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| 3 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| 4 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| Rectum | ND | 0 | NA | 0 | 0 | 0 | None. | |||||
| Anastomosis | Mean | 0.00 | 0.00 | 4.00 | 0.00 | 2.00 | ||||||
| Day 35: Group 1 - Vacuum (n=4) | Mean | 0.00 | 0.00 | 4.00 | 0.00 | 2.00 | ||||||
| SD | 0.00 | 0.00 | 0.00 | 0.00 | 0.20 | |||||||
| Median | 0.00 | 0.00 | 4.00 | 0.00 | 2.00 | |||||||
| Incidence | 0% | 0% | 100% | 0% | 100% | |||||||
| Day 35 | Group 2 | No Vacuum | 52852 | Rectum | NP | 0 | NA | 0 | 0 | 0 | None. | |
| Anastomosis | 1 | 0 | 0 | 4 | 0 | 2 | Presence of mucosal glands on the serosal surface with inflammation due to anastomosis procedure. Staples with surrounding inflammation are present. | |||||
| 2 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| 3 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| 4 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| Rectum | ND | 0 | NA | 0 | 0 | 0 | None. | |||||
| Anastomosis | Mean | 0.00 | 0.00 | 4.00 | 0.00 | 2.00 | ||||||
| 52949 | Rectum | NP | 0 | NA | 0 | 0 | 0 | Indentation noted within mucosa with inflammatory infiltrate likely to be preexisting background finding or part of anastomosis site inadvertently captured in the section. | ||||
| Anastomosis | 1 | 0 | 0 | 4 | 0 | 1 | Staples with surrounding inflammation are present. | |||||
| 2 | 0 | 0 | 4 | 0 | 1 | Staple with surrounding inflammation is present. Presence of mucosal glands on the serosal surface with inflammation due to anastomosis procedure. | ||||||
| 3 | 0 | 0 | 4 | 0 | 2 | Staple with surrounding inflammation is present. Mucosal pseudo diverticulum formation with ingesta and debris accumulation. | ||||||
| 4 | 0 | 0 | 4 | 0 | 2 | Staples with surrounding inflammation are present. | ||||||
| Rectum | ND | 0 | NA | 0 | 0 | 0 | Lymphoid follicles present within submucosa. | |||||
| Anastomosis | Mean | 0.00 | 0.00 | 4.00 | 0.00 | 1.50 | ||||||
| Day 35: Group 2 - No Vacuum (n=2) | Mean SD | 0.00 | 0.00 | 4.00 | 0.00 | 1.75 | ||||||
| Median | 0.00 | 0.00 | 0.00 | 0.00 | 0.35 | |||||||
| Incidence | 0.00 | 0.00 | 4.00 | 0.00 | 1.75 | |||||||
| 0% | 0% | 100% | 0% | 100% | ||||||||