Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation (ColonPerfRCT)
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ClinicalTrials.gov Identifier: NCT01233713 |
Recruitment Status
:
Completed
First Posted
: November 3, 2010
Last Update Posted
: May 28, 2012
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Condition or disease | Intervention/treatment | Phase |
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Surgery Diverticulitis Neoplasms Postoperative Complications | Procedure: Hartmann's operation Procedure: Primary anastomosis | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Primary anastomosis
Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation.
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Procedure: Primary anastomosis
Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
Other Name: Colectomy, primary anastomosis and defunctioning ileostomy
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Active Comparator: Hartmann's 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.
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Procedure: Hartmann's 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.
Other Name: Colectomy with a proximal-end colostomy
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- Overall post-operative complication rate defined according to the Clavien-Dindo Classification [ Time Frame: 2006 - 2010 ]
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
- Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation [ Time Frame: 2006 - 2010 ]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 [ Time Frame: 2006 - 2010 ]Reversal operation is the one of either the colostomy (Hartmann's) or the ileostomy (Primary anastomosis)
- Overall total number of complications [ Time Frame: 2006 - 2010 ]Sum of the number of different complications
- Number of complications for the primary operation [ Time Frame: 2006 - 2010 ]Primary operation is the one patients were randomized into.
- Number of complications for the reversal operation [ Time Frame: 2006 - 2010 ]As above
- Reversal rate [ Time Frame: 2006 - 2010 ]Reversal rate is the proportion of patients having their stoma reversed (second operation)
- Operation time [ Time Frame: 2006 - 2010 ]Duration of the primary procedure, the reversal procedure, and overall (minutes)
- Length of Intensive Care Unit (ICU) stay [ Time Frame: 2006 - 2010 ]In days
- Length of hospital stay [ Time Frame: 2006 - 2010 ]In days
- In-hospital costs [ Time Frame: 2006 - 2010 ]Cost of the primary operation, the reversal, and combined, in US dollars.

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Ages Eligible for Study: | 18 Years to 95 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233713
Switzerland | |
Kantonsspital Graubünden | |
Chur, Graubünden, Switzerland, 7000 | |
University Hospital Vaudois (CHUV), Department of Visceral Surgery | |
Lausanne, Switzerland, 1011 | |
Kantonsspital Winterthur | |
Winterthur, Switzerland, 8401 | |
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center | |
Zurich, Switzerland, 8091 |
Principal Investigator: | Stefan Breitenstein, MD | University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT01233713 History of Changes |
Other Study ID Numbers: |
Colon_Perf_RCT |
First Posted: | November 3, 2010 Key Record Dates |
Last Update Posted: | May 28, 2012 |
Last Verified: | May 2012 |
Keywords provided by University of Zurich:
Emergency Surgery Bowel perforation Diverticulitis |
Neoplasms Postoperative Complications Randomized Controlled Trial |
Additional relevant MeSH terms:
Postoperative Complications Diverticulitis Pathologic Processes Intraabdominal Infections |
Infection Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |