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| Name | Class |
|---|---|
| Kantonsspital Winterthur KSW | OTHER |
| University of Lausanne | OTHER |
| Kantonsspital Graubünden | OTHER |
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The purpose of this multi-center randomized trial is to identify any differences in the complication rates of patients undergoing Hartmann's (end colostomy) versus Primary Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the stoma reversal operation).
Hartmann's operation: the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy.
End colostomy: A stoma is created from one end of the bowel while the other portion of the bowel is either removed or sewn shut (Hartmann's pouch).
The second operation (reversal) requires a colo-rectal anastomosis.
Primary anastomosis: colonic resection with primary anastomosis and defunctioning ileostomy. The second operation (stoma reversal) requires an entero-enteral anastomosis.
Anastomosis: is to join together two bowel ends to restore continuity after resection or stoma formation.
Colostomy: is a reversible surgical procedure in which a stoma is formed by drawing the healthy end of the colon through an incision in the anterior abdominal wall and suturing it into place. This opening, in conjunction with the attached stoma appliance, provides an alternative channel for feces to leave the body.
Ileostomy is a surgical opening constructed by bringing the loop of small intestine (the ileum) out onto the surface of the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary anastomosis | Active Comparator | Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation. |
|
| Hartmann's operation | Active Comparator | Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hartmann's operation | Procedure | Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall post-operative complication rate defined according to the Clavien-Dindo Classification | The Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient | 2006 - 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation | Primary operation: the one the patients were randomized to, either Hartmann's or Primary anastomosis | 2006 - 2010 |
| Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Breitenstein, MD | University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19638912 | Background | Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. | |
| 23095627 |
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| ID | Term |
|---|---|
| D004238 | Diverticulitis |
| D009369 | Neoplasms |
| D011183 | Postoperative Complications |
| D007416 | Intestinal Perforation |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003082 | Colectomy |
| ID | Term |
|---|---|
| D000099090 | Surgical Procedures, Colorectal |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Primary anastomosis | Procedure | Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation. |
|
|
Reversal operation is the one of either the colostomy (Hartmann's) or the ileostomy (Primary anastomosis) |
| 2006 - 2010 |
| Overall total number of complications | Sum of the number of different complications | 2006 - 2010 |
| Number of complications for the primary operation | Primary operation is the one patients were randomized into. | 2006 - 2010 |
| Number of complications for the reversal operation | As above | 2006 - 2010 |
| Reversal rate | Reversal rate is the proportion of patients having their stoma reversed (second operation) | 2006 - 2010 |
| Operation time | Duration of the primary procedure, the reversal procedure, and overall (minutes) | 2006 - 2010 |
| Length of Intensive Care Unit (ICU) stay | In days | 2006 - 2010 |
| Length of hospital stay | In days | 2006 - 2010 |
| In-hospital costs | Cost of the primary operation, the reversal, and combined, in US dollars. | 2006 - 2010 |
| Kantonsspital Graubünden | Chur | Kanton Graubünden | 7000 | Switzerland |
| University Hospital Vaudois (CHUV), Department of Visceral Surgery | Lausanne | Lausanne | 1011 | Switzerland |
| Kantonsspital Winterthur | Winterthur | Winterthur | 8401 | Switzerland |
| Oberkofler CE, Rickenbacher A, Raptis DA, Lehmann K, Villiger P, Buchli C, Grieder F, Gelpke H, Decurtins M, Tempia-Caliera AA, Demartines N, Hahnloser D, Clavien PA, Breitenstein S. A multicenter randomized clinical trial of primary anastomosis or Hartmann's procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis. Ann Surg. 2012 Nov;256(5):819-26; discussion 826-7. doi: 10.1097/SLA.0b013e31827324ba. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007410 | Intestinal Diseases |