Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation (ColonPerfRCT)
Primary Purpose
Surgery, Diverticulitis, Neoplasms
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Hartmann's operation
Primary anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Surgery focused on measuring Emergency Surgery, Bowel perforation, Diverticulitis, Neoplasms, Postoperative Complications, Randomized Controlled Trial
Eligibility Criteria
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
Sites / Locations
- Kantonsspital Graubünden
- University Hospital Vaudois (CHUV), Department of Visceral Surgery
- Kantonsspital Winterthur
- University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Primary anastomosis
Hartmann's operation
Arm Description
Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
Overall total number of complications
Sum of the number of different complications
Number of complications for the primary operation
Primary operation is the one patients were randomized into.
Number of complications for the reversal operation
As above
Reversal rate
Reversal rate is the proportion of patients having their stoma reversed (second operation)
Operation time
Duration of the primary procedure, the reversal procedure, and overall (minutes)
Length of Intensive Care Unit (ICU) stay
In days
Length of hospital stay
In days
In-hospital costs
Cost of the primary operation, the reversal, and combined, in US dollars.
Full Information
NCT ID
NCT01233713
First Posted
November 2, 2010
Last Updated
May 25, 2012
Sponsor
University of Zurich
Collaborators
Kantonsspital Winterthur KSW, University of Lausanne, Kantonsspital Graubünden
1. Study Identification
Unique Protocol Identification Number
NCT01233713
Brief Title
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation
Acronym
ColonPerfRCT
Official Title
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Kantonsspital Winterthur KSW, University of Lausanne, Kantonsspital Graubünden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Diverticulitis, Neoplasms, Postoperative Complications
Keywords
Emergency Surgery, Bowel perforation, Diverticulitis, Neoplasms, Postoperative Complications, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary anastomosis
Arm Type
Active Comparator
Arm Description
Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation.
Arm Title
Hartmann's operation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hartmann's operation
Other Intervention Name(s)
Colectomy with a proximal-end colostomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Primary anastomosis
Other Intervention Name(s)
Colectomy, primary anastomosis and defunctioning ileostomy
Intervention Description
Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
Primary Outcome Measure Information:
Title
Overall post-operative complication rate defined according to the Clavien-Dindo Classification
Description
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
Time Frame
2006 - 2010
Secondary Outcome Measure Information:
Title
Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation
Description
Primary operation: the one the patients were randomized to, either Hartmann's or Primary anastomosis
Time Frame
2006 - 2010
Title
Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation
Description
Reversal operation is the one of either the colostomy (Hartmann's) or the ileostomy (Primary anastomosis)
Time Frame
2006 - 2010
Title
Overall total number of complications
Description
Sum of the number of different complications
Time Frame
2006 - 2010
Title
Number of complications for the primary operation
Description
Primary operation is the one patients were randomized into.
Time Frame
2006 - 2010
Title
Number of complications for the reversal operation
Description
As above
Time Frame
2006 - 2010
Title
Reversal rate
Description
Reversal rate is the proportion of patients having their stoma reversed (second operation)
Time Frame
2006 - 2010
Title
Operation time
Description
Duration of the primary procedure, the reversal procedure, and overall (minutes)
Time Frame
2006 - 2010
Title
Length of Intensive Care Unit (ICU) stay
Description
In days
Time Frame
2006 - 2010
Title
Length of hospital stay
Description
In days
Time Frame
2006 - 2010
Title
In-hospital costs
Description
Cost of the primary operation, the reversal, and combined, in US dollars.
Time Frame
2006 - 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Breitenstein, MD
Organizational Affiliation
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Graubünden
City
Chur
State/Province
Graubünden
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
University Hospital Vaudois (CHUV), Department of Visceral Surgery
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19638912
Citation
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.
Results Reference
background
PubMed Identifier
23095627
Citation
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.
Results Reference
derived
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Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation
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