SurgeryPhase 2/3ColonPerfRCTNCT01233713
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation
A Phase 2/3 study testing Hartmann's operation and Primary anastomosis in people with Surgery and Diverticulitis, run by University of Zurich at 4 sites in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Surgery, Diverticulitis, Neoplasms
- What is being tested?
- Hartmann's operation and Primary anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesSwitzerland
- Study dates
- May 2006to May 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age > 18 years
- Left-sided colon perforation
- German language speakers
Who cannot join
- Patient age < 18 years
- Perforation outside of the left-colon
- Bowel obstruction/disease without perforation
- Evidence of metastasis
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
University Hospital Vaudois (CHUV), Department of Visceral Surgery
Lausanne, Lausanne, 1011
Kantonsspital Winterthur
Winterthur, Winterthur, 8401
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Canton of Zurich, 8091
About this study
Official title: Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial
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).
Read the 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.
- Conditions
- Surgery, Diverticulitis, Neoplasms, Postoperative Complications
- Being tested
- Hartmann's operation, Primary anastomosis
- Keywords
- Emergency Surgery, Bowel perforation, Diverticulitis, Neoplasms, Postoperative Complications, Randomized Controlled Trial
- Medical subject headings
- Diverticulitis, Neoplasms, Postoperative Complications, Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hartmann's operationProcedure or surgery
Also called Colectomy with a proximal-end colostomy
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.
Primary anastomosisProcedure or surgery
Also called Colectomy, primary anastomosis and defunctioning ileostomy
Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
| Study group | Role | What they receive |
|---|---|---|
| Primary anastomosis | Active comparator | Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation. Receives: Procedure: Primary anastomosis |
| 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. Receives: Procedure: Hartmann's operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2006 - 2010
Secondary outcomes (10)
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
Measured: 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)
Measured: 2006 - 2010
Overall total number of complications
Sum of the number of different complications
Measured: 2006 - 2010
Number of complications for the primary operation
Primary operation is the one patients were randomized into.
Measured: 2006 - 2010
Number of complications for the reversal operation
As above
Measured: 2006 - 2010
Reversal rate
Reversal rate is the proportion of patients having their stoma reversed (second operation)
Measured: 2006 - 2010
Operation time
Duration of the primary procedure, the reversal procedure, and overall (minutes)
Measured: 2006 - 2010
Length of Intensive Care Unit (ICU) stay
In days
Measured: 2006 - 2010
Length of hospital stay
In days
Measured: 2006 - 2010
In-hospital costs
Cost of the primary operation, the reversal, and combined, in US dollars.
Measured: 2006 - 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startMay 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW, University of Lausanne, Kantonsspital Graubünden
- Responsible party
- Sponsor
- Investigators
- Stefan Breitenstein, MD, Principal investigator, University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233713
- Sponsor's protocol ID
- Colon_Perf_RCT
- Acronym
- ColonPerfRCT
- Status last verified
- May 2012
- First submitted
- 2 Nov 2010
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19638912Oberkofler 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.
PubMed 23095627
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT01233713
- Acronym / sponsor ID
- ColonPerfRCT / Colon_Perf_RCT
- Conditions
- Surgery, Diverticulitis, Neoplasms, Postoperative Complications
- Keywords
- Emergency Surgery, Bowel perforation, Diverticulitis, Neoplasms, Postoperative Complications, Randomized Controlled Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW, University of Lausanne, Kantonsspital Graubünden
- Study start
- May 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary anastomosis | Active comparator | Procedure: Primary anastomosisPrimary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation. |
| Hartmann's operation | Active comparator | Procedure: Hartmann's operationHartmann'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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age > 18 years
- Left-sided colon perforation
- German language speakers
Key exclusion criteria (4 listed)
- Patient age < 18 years
- Perforation outside of the left-colon
- Bowel obstruction/disease without perforation
- Evidence of metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hartmann's operationAlso: Colectomy with a proximal-end colostomyHartmann'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 or surgery | Hartmann's operation |
| Primary anastomosisAlso: Colectomy, primary anastomosis and defunctioning ileostomyPrimary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation. | Procedure or surgery | Primary anastomosis |
Primary outcome
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
10 secondary outcomes
Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation
Time frame: 2006 - 2010
Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation
Time frame: 2006 - 2010
Overall total number of complications
Time frame: 2006 - 2010
Number of complications for the primary operation
Time frame: 2006 - 2010
Number of complications for the reversal operation
Time frame: 2006 - 2010
Reversal rate
Time frame: 2006 - 2010
Operation time
Time frame: 2006 - 2010
Length of Intensive Care Unit (ICU) stay
Time frame: 2006 - 2010
Length of hospital stay
Time frame: 2006 - 2010
In-hospital costs
Time frame: 2006 - 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Background: PubMed 19638912Clavien 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.
- Derived from this study: PubMed 23095627Oberkofler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Breitenstein, MD principal investigator
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hartmann's operation and Primary anastomosis in people with Surgery and Diverticulitis, run by University of Zurich at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall post-operative complication rate defined according to the Clavien-Dindo Classification (time frame: 2006 - 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01233713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.