Bacterium-Related Malignant NeoplasmNCT02527382
Peritoneal Bacterial Contamination Following Resection With Closed or Open Rectal Stump for Left-sided Cancer
A study testing Closed stump in people with Bacterium-Related Malignant Neoplasm, run by Florin Iordache.
Trial summary
The purpose of this study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterium-Related Malignant Neoplasm
- What is being tested?
- Closed stump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adult patients scheduled for a left colectomy, sigmoidectomy or rectal resection with a proposed anastomosis at the level of the rectum agreeing to participate in the study.
Who cannot join
- Patients without informed consent
- Class V patients on American Society of Anesthesiologists (ASA) of Physical Health Score
- Patient with prior peritonitis
- Patients with acute inflammatory bowel disease
- Recent antibiotic treatment
About this study
Official title: Peritoneal Bacterial Contamination With Closed or Open Rectal Stump
The purpose of this study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.
Read the detailed description
There is not much information regarding the peritoneal bacterial contamination during colorectal surgery. The null hypothesis is that there is no difference in peritoneal contamination following resection with closed or open rectal stump for left-sided cancer. Patients scheduled for elective resection are allocated for open resection with the distal stump closed or open. Anastomosis is performed while a clamp is placed on the rectal stump in one arm of the study while in the other arm, the stump remains open until the anastomosis is completed. A second bacterial sample will be obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. After sampling an air leak test will be performed. A quantitative assessment of the number of Colony Forming Units (CFU/ml) of aerobic and anaerobic bacteria will be done for each patient. Operative time and time interval between samples will be measured. Postoperatively, possible complications (surgical site infections, leakage) will be monitored. The primary objective will be to determine the differences in peritoneal contamination between closed and open rectal stump during colorectal surgery.
- Conditions
- Bacterium-Related Malignant Neoplasm
- Being tested
- Closed stump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed stumpProcedure or surgery
Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while a bowel clamp is placed on the rectal stump. A second bacterial sample is obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one.
| Study group | Role | What they receive |
|---|---|---|
| Closed stump | Experimental | Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while a distal clamp is placed on the rectal stump. Receives: Procedure: Closed stump |
| Open stump | No intervention | Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while no distal clamp is placed on the rectal stump. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Colony-Forming Units (CFU)/ml from the peritoneal samples
The formula we will use is: number of CFU (colony forming units)/ml = n x 10 x d, where n = number of colonies on the media and d = dilution reverse. The final number of CFU/ml will be given as the arithmetic mean of the three dilutions done for each sample. When no bacterial growth is found the results are given as 0 CFU/ml. The maximum limit is considered 100,000 CFU/ml.
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterium-Related Malignant NeoplasmStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florin Iordache
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Florin Iordache, Bucharest Emergency Hospital
- Investigators
- Florin M Iordache, MD, Principal investigator, Bucharest Emergency Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527382
- Sponsor's protocol ID
- 23937
- Status last verified
- Aug 2015
- First submitted
- 16 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal Bacterial Contamination With Closed or Open Rectal Stump
- ClinicalTrials.gov ID
- NCT02527382
- Acronym / sponsor ID
- 23937
- Conditions
- Bacterium-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Florin IordacheUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Aug 2015 (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 study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.
Detailed description
There is not much information regarding the peritoneal bacterial contamination during colorectal surgery. The null hypothesis is that there is no difference in peritoneal contamination following resection with closed or open rectal stump for left-sided cancer. Patients scheduled for elective resection are allocated for open resection with the distal stump closed or open. Anastomosis is performed while a clamp is placed on the rectal stump in one arm of the study while in the other arm, the stump remains open until the anastomosis is completed. A second bacterial sample will be obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. After sampling an air leak test will be performed. A quantitative assessment of the number of Colony Forming Units (CFU/ml) of aerobic and anaerobic bacteria will be done for each patient. Operative time and time interval between samples will be measured. Postoperatively, possible complications (surgical site infections, leakage) will be monitored. The primary objective will be to determine the differences in peritoneal contamination between closed and open rectal stump during colorectal surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed stump | Experimental | Procedure: Closed stumpBefore cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while a distal clamp is placed on the rectal stump. |
| Open stump | No intervention | –Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while no distal clamp is placed on the rectal stump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive adult patients scheduled for a left colectomy, sigmoidectomy or rectal resection with a proposed anastomosis at the level of the rectum agreeing to participate in the study.
Key exclusion criteria (5 listed)
- Patients without informed consent
- Class V patients on American Society of Anesthesiologists (ASA) of Physical Health Score
- Patient with prior peritonitis
- Patients with acute inflammatory bowel disease
- Recent antibiotic treatment
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 |
|---|---|---|
| Closed stumpBefore cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while a bowel clamp is placed on the rectal stump. A second bacterial sample is obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. | Procedure or surgery | Closed stump |
Primary outcome
The number of Colony-Forming Units (CFU)/ml from the peritoneal samples
Time frame: within the first 30 days after surgery
The formula we will use is: number of CFU (colony forming units)/ml = n x 10 x d, where n = number of colonies on the media and d = dilution reverse. The final number of CFU/ml will be given as the arithmetic mean of the three dilutions done for each sample. When no bacterial growth is found the results are given as 0 CFU/ml. The maximum limit is considered 100,000 CFU/ml.
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 19 Aug 2015.
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.
Florin M Iordache, MD principal investigator
Bucharest Emergency Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Closed stump in people with Bacterium-Related Malignant Neoplasm, run by Florin Iordache.
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 5 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The number of Colony-Forming Units (CFU)/ml from the peritoneal samples (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2015.