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After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NITI CAR27 (ColonRing) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression Anastomosis Device | Device | Restoring intestinal continuity using the NITI CAR27 device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic Leakage | 4-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Relevant Stenosis | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Friedrich Herbst, MD, FRCS | St John of God Hospital, Vienna | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21541799 | Derived | Dauser B, Winkler T, Loncsar G, Herbst F. Compression anastomosis revisited: prospective audit of short- and medium-term outcomes in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/s00268-011-1135-2. |
| Label | URL |
|---|---|
| About BioDynamix Anastomosis | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | NITI CAR27 (ColonRing) | Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NITI CAR27 (ColonRing) | Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anastomotic Leakage | Posted | Number | participants | 4-8 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NITI CAR27 (ColonRing) | Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomotic stenosis | Gastrointestinal disorders | Systematic Assessment | Symptomatic anastomotic stenosis resolved by endoscopic dilatation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernhard Dauser (MD) | St John of God Hospital Vienna | +43121121 | 5098 | bernhard.dauser@gmail.com |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D004238 | Diverticulitis |
| D015212 | Inflammatory Bowel Diseases |
| D012005 | Rectal Prolapse |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| follow-up colonoscopy | Other | endoscopic exploration of anastomosis after complete healing |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Clinical Relevant Stenosis | Not Posted | six months |
| 2 |
| 62 |
| 0 |
| 62 |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |