Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial

Conditions
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Surgery, Diverticulitis, Neoplasms, Postoperative Complications

Intervention / Treatment
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* Procedure: Hartmann's operation
* Procedure: Primary anastomosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age > 18 years Left-sided colon perforation German language speakers Exclusion Criteria: Patient age < 18 years Perforation outside of the left-colon Bowel obstruction/disease without perforation Evidence of metastasis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary anastomosis<br>Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation. | Procedure: Primary anastomosis<br>* Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.<br>* Other names: Colectomy, primary anastomosis and defunctioning ileostomy;|
| Active Comparator: Hartmann's operation<br>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. | Procedure: Hartmann's operation<br>* 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.<br>* Other names: Colectomy with a proximal-end colostomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency Surgery, Bowel perforation, Diverticulitis, Neoplasms, Postoperative Complications, Randomized Controlled Trial