Colitis, Ulcerative, Colorectal Neoplasms, Colostomy, Crohn Disease, Diverticulum, Colon, Endometriosis, Ileostomy - Stoma, Intestinal Polyposis, Intestinal Volvulus, Lymphoma, Rectal Prolapse
Conditions
Keywords
Compression Anastomosis
Brief summary
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures. Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
Interventions
None listed
Sponsors
novoGI
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient was \> 18 years old at time of procedure 2. Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™ 3. Patient treated in routine clinical practice 4. Patient underwent his/her first follow-up visit within two months post-surgery
Exclusion criteria
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of anastomotic leakage. | 6 weeks after the procedure | Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of other device related complications and measures during hospitalization and post procedure. | 6 weeks after the procedure. | The Following complications will be examined: Bleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess) Readmission, re-operation, death within two months of the procedure Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter) The following post operative measures will be reported: Hospitalization duration (two dates will be recorded: ready for discharge and discharge). The latter noting where the patient was discharged to - e.g. nursing home or home. First day to first postoperative flatus. First day to first postoperative bowel movements. First day of first postoperative toleration of liquids and solids (time to keeping them down) |
Countries
United States
Outcome results
None listed