Peritoneal Contamination After Ileocolonic AnastomosisPhase 3NCT01458353
Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer
A Phase 3 study testing Stapled anastomosis and Handsewn anastomosis in people with Peritoneal Contamination After Ileocolonic Anastomosis and Wound Infection, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
Despite performing colonic surgery with strict asepsia measures, minimizing the contact of the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In stapled anastomosis, the hole opened in the colon is minimum, just the necessary for introducing the parts of the mechanical devices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Contamination After Ileocolonic Anastomosis, Wound Infection, Intra-abdominal Abscess
- What is being tested?
- Stapled anastomosis and Handsewn anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General de Elche
Elche, Alicante, 03202
Jaime Ruiz-Tovar, MD, PhD, (0034)630534808, jruiztovar@gmail.com
About this study
Official title: Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer: Are There Differences in the Peritoneal Contamination After Performing a Stapled or a Handsewn Anastomosis?
Despite performing colonic surgery with strict asepsia measures, minimizing the contact of the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In stapled anastomosis, the hole opened in the colon is minimum, just the necessary for introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the suture is performed.
Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than after handsewn ones.
- Conditions
- Peritoneal Contamination After Ileocolonic Anastomosis, Wound Infection, Intra-abdominal Abscess
- Being tested
- Stapled anastomosis, Handsewn anastomosis
- Keywords
- Right-sided colon cancer, Ileocolonic anastomosis, stapled anastomosis, handsewn anastomosis, peritoneal contamination, microbiological spectrum
- Medical subject headings
- Wound Infection, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapled anastomosisProcedure or surgery
Stapled anastomosis after ileocolonic resection
Handsewn anastomosisProcedure or surgery
Handsewn anastomosis after ileocolonic resection
| Study group | Role | What they receive |
|---|---|---|
| Handsewn ileocolonic anastomosis | Experimental | Swabs obtained from patients undergoing handsewn ileocolonic anastomosis Receives: Procedure: Handsewn anastomosis |
| Stapled ileocolonic anastomosis | Experimental | Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis Receives: Procedure: Stapled anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal contamination after finishing the ileocolonic anastomosis
Swabs will be obtained from the peritoneal surface for microbiological culture
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Contamination After Ileocolonic AnastomosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Jaime Ruiz-Tovar, MD, PhD, Principal investigator, Hospital General de ElcheAntonio Arroyo, MD, PhD, Study director, Hospital General de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458353
- Sponsor's protocol ID
- HGUElche1
- Status last verified
- Oct 2011
- First submitted
- 19 Oct 2011
- Last updated
- 24 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Lopez A, Frangi A, Armananzas L, Alcaide MJ, Candela F, Calpena R. Microbiological spectrum of the intraperitoneal surface after elective right-sided colon cancer: are there differences in the peritoneal contamination after performing a stapled or a handsewn anastomosis? Int J Colorectal Dis. 2012 Nov;27(11):1515-9. doi: 10.1007/s00384-012-1492-9. Epub 2012 May 12.
PubMed 22581209
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer: Are There Differences in the Peritoneal Contamination After Performing a Stapled or a Handsewn Anastomosis?
- ClinicalTrials.gov ID
- NCT01458353
- Acronym / sponsor ID
- HGUElche1
- Conditions
- Peritoneal Contamination After Ileocolonic Anastomosis, Wound Infection, Intra-abdominal Abscess
- Keywords
- Right-sided colon cancer, Ileocolonic anastomosis, stapled anastomosis, handsewn anastomosis, peritoneal contamination, microbiological spectrum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 24 Oct 2011 (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.
Despite performing colonic surgery with strict asepsia measures, minimizing the contact of the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In stapled anastomosis, the hole opened in the colon is minimum, just the necessary for introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the suture is performed.
Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than after handsewn ones.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Handsewn ileocolonic anastomosis | Experimental | Procedure: Handsewn anastomosisSwabs obtained from patients undergoing handsewn ileocolonic anastomosis |
| Stapled ileocolonic anastomosis | Experimental | Procedure: Stapled anastomosisSwabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Stapled anastomosisStapled anastomosis after ileocolonic resection | Procedure or surgery | Stapled ileocolonic anastomosis |
| Handsewn anastomosisHandsewn anastomosis after ileocolonic resection | Procedure or surgery | Handsewn ileocolonic anastomosis |
Primary outcome
Peritoneal contamination after finishing the ileocolonic anastomosis
Time frame: 1 year
Swabs will be obtained from the peritoneal surface for microbiological culture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
- Derived from this study: PubMed 22581209Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Lopez A, Frangi A, Armananzas L, Alcaide MJ, Candela F, Calpena R. Microbiological spectrum of the intraperitoneal surface after elective right-sided colon cancer: are there differences in the peritoneal contamination after performing a stapled or a handsewn anastomosis? Int J Colorectal Dis. 2012 Nov;27(11):1515-9. doi: 10.1007/s00384-012-1492-9. Epub 2012 May 12.
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.
Jaime Ruiz-Tovar, MD, PhD principal investigator
Hospital General de Elche
Antonio Arroyo, MD, PhD study director
Hospital General de Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stapled anastomosis and Handsewn anastomosis in people with Peritoneal Contamination After Ileocolonic Anastomosis and Wound Infection, run by Hospital General Universitario Elche at 1 site in Spain.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime Jaime, MD, PhD ((0034)630534808, jruiztovar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal contamination after finishing the ileocolonic anastomosis (time frame: 1 year). 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 NCT01458353, which also lists 1 linked publication.
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 24 Oct 2011.