Surgical Site InfectionNCT04258098
Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs: A Propensity Analysis
An observational study of Surgical Site Infection and Colorectal Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
Surgical site infections (SSIs) are a major postoperative complication after colorectal surgery. Current study aims to evaluate prophylactic function of oral antibiotic intake (OA) in combination with mechanical bowel preparation (MBP) relative to MBP alone with respect to postoperative SSIs incidence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection, Colorectal Cancer
- What is being tested?
- Oral antibiotics ( Streptomycin ,metronidazole )
- Type of treatment
- Pill or oral medicine
- How many people
- 806 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 12 May 2019
- Phase
- Observational
- 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
Study population: Eligible patients were identified by searching the database of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University from 2011 to 2017.
Who may be able to join
- Patient underwent elective colorectal resection to treat a malignancy;
- Patient baseline characteristics and operative information were available;
- MBP (mechanical bowel preparation) was performed before surgery, with or without OA (oral antibiotics).
Who cannot join
- Emergency surgery;
- MBP was not conducted due to ileus or patient refusal;
- Enough data was not available;
- Colorectal resection was performed due to benign disease;
- The procedure was accompanied by other procedures that had the potential to contaminate the incision, such as cholecystectomy or appendectomy;
- Patients underwent neoadjuvant radiotherapy before surgery.
About this study
Official title: Preoperative Mechanical Bowel Preparation With Oral Antibiotics Reduces Surgical Site Infection After Elective Colorectal Surgery for Malignancies: a Propensity Matching Analysis
Surgical site infections (SSIs) are a major postoperative complication after colorectal surgery. Current study aims to evaluate prophylactic function of oral antibiotic intake (OA) in combination with mechanical bowel preparation (MBP) relative to MBP alone with respect to postoperative SSIs incidence. A retrospective analysis of eligible patients was to conducted using the databases of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University from 2011 to 2017. Data pertaining to postoperative hospital stay length, expenses, SSIs incidence, anastomotic fistula incidence, and rates of other complications wloud be extracted and compared. A propensity analysis was conducted to minimize bias associated with demographic characteristics.
Read the detailed description
Surgical site infections (SSIs) are a major postoperative complication after abdominal surgery, especially in the colorectal field. With a reported incidence of over 20%, SSIs significantly increase the length of stay (LOS), readmission rate, expenses, and mortality . Therefore, the identification of an effective method of reducing SSIs incidence is critically important.
Colonic bacterial florae are considered to be the major cause of SSIs after elective colorectal procedures, but the most effective means of decreasing this bacterial load remains under debate. Pre-operative mechanical bowel preparation (MBP) was first utilized by surgeons, as it can theoretically remove stool content and associated bacterial load within the bowel and surgical field, thus reducing risk of SSIs. More recently, as antibiotics have come to be widely utilized, the pre-operative administration of un-absorbed oral antibiotics (OA) in combination with MBP was widely conducted.
Multiple trials have been performed to explore the best bowel preparation strategies, but their results remain controversial. Since 2005, several RCTs and meta-analyses have demonstrated MBP alone was not associated with a reduced incidence of SSIs related to patients that did not undergo MBP, whereas MBP patients exhibited paradoxical increases in postoperative ileus, anastomotic leakage, and other complications. Recently, the merit of OA and MBP has been re-discovered in several related retrospective studies which demonstrated a significant decrease in the rate of SSIs.However, as information in these trials was exacted from national databases without any detailed matching between patient groups, the existence of bias in these trials may affect the validity of their results. Furthermore, none of these studies assessed the relative prophylactic effects of the novel MBP mode in right or left-side colorectal surgery.
- Conditions
- Surgical Site Infection, Colorectal Cancer
- Being tested
- Oral antibiotics ( Streptomycin ,metronidazole )
- Medical subject headings
- Surgical Wound Infection, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral antibiotics ( Streptomycin ,metronidazole )Drug
Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. Streptomycin 1g plus metronidazole 0.2g was prescribed 3 times a day for 3 days before surgery in the OA+MBP group patients.
| Study group | Role | What they receive |
|---|---|---|
| OA+MBP group | Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. Streptomycin 1g plus metronidazole 0.2g was prescribed 3 times a day for 3 days before surgery in the OA+MBP group patients. Receives: Drug: Oral antibiotics ( Streptomycin ,metronidazole ) | |
| MBP group | Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. No oral antibiotics was administered to the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSIs incidence
Surgical site infection incidence
Measured: up to 30 days postoperatively
Secondary outcomes (1)
length of hospital stays
length of hospital stays after colorectal surgeries
Measured: up to 3 months posteroperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jan 2011
- Primary completion31 Dec 2017
- Study completion12 May 2019
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 Surgical Site InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258098
- Sponsor's protocol ID
- OAMBP-02
- Other IDs
- 2018023
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lei P, Ruan Y, Yang X, Wu J, Hou Y, Wei H, Chen T. Preoperative mechanical bowel preparation with oral antibiotics reduces surgical site infection after elective colorectal surgery for malignancies: results of a propensity matching analysis. World J Surg Oncol. 2020 Feb 11;18(1):35. doi: 10.1186/s12957-020-1804-4.
PubMed 32046725
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Mechanical Bowel Preparation With Oral Antibiotics Reduces Surgical Site Infection After Elective Colorectal Surgery for Malignancies: a Propensity Matching Analysis
- ClinicalTrials.gov ID
- NCT04258098
- Acronym / sponsor ID
- OAMBP-02
- Conditions
- Surgical Site Infection, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 12 May 2019 (actual)
- First posted
- 6 Feb 2020 (actual)
- 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.
Surgical site infections (SSIs) are a major postoperative complication after colorectal surgery. Current study aims to evaluate prophylactic function of oral antibiotic intake (OA) in combination with mechanical bowel preparation (MBP) relative to MBP alone with respect to postoperative SSIs incidence. A retrospective analysis of eligible patients was to conducted using the databases of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University from 2011 to 2017. Data pertaining to postoperative hospital stay length, expenses, SSIs incidence, anastomotic fistula incidence, and rates of other complications wloud be extracted and compared. A propensity analysis was conducted to minimize bias associated with demographic characteristics.
Detailed description
Surgical site infections (SSIs) are a major postoperative complication after abdominal surgery, especially in the colorectal field. With a reported incidence of over 20%, SSIs significantly increase the length of stay (LOS), readmission rate, expenses, and mortality . Therefore, the identification of an effective method of reducing SSIs incidence is critically important.
Colonic bacterial florae are considered to be the major cause of SSIs after elective colorectal procedures, but the most effective means of decreasing this bacterial load remains under debate. Pre-operative mechanical bowel preparation (MBP) was first utilized by surgeons, as it can theoretically remove stool content and associated bacterial load within the bowel and surgical field, thus reducing risk of SSIs. More recently, as antibiotics have come to be widely utilized, the pre-operative administration of un-absorbed oral antibiotics (OA) in combination with MBP was widely conducted.
Multiple trials have been performed to explore the best bowel preparation strategies, but their results remain controversial. Since 2005, several RCTs and meta-analyses have demonstrated MBP alone was not associated with a reduced incidence of SSIs related to patients that did not undergo MBP, whereas MBP patients exhibited paradoxical increases in postoperative ileus, anastomotic leakage, and other complications. Recently, the merit of OA and MBP has been re-discovered in several related retrospective studies which demonstrated a significant decrease in the rate of SSIs.However, as information in these trials was exacted from national databases without any detailed matching between patient groups, the existence of bias in these trials may affect the validity of their results. Furthermore, none of these studies assessed the relative prophylactic effects of the novel MBP mode in right or left-side colorectal surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OA+MBP group | – | Drug: Oral antibiotics ( Streptomycin ,metronidazole )Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. Streptomycin 1g plus metronidazole 0.2g was prescribed 3 times a day for 3 days before surgery in the OA+MBP group patients. |
| MBP group | – | –Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. No oral antibiotics was administered to the patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients were identified by searching the database of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University from 2011 to 2017.
Key inclusion criteria (3 listed)
- Patient underwent elective colorectal resection to treat a malignancy;
- Patient baseline characteristics and operative information were available;
- MBP (mechanical bowel preparation) was performed before surgery, with or without OA (oral antibiotics).
Key exclusion criteria (6 listed)
- Emergency surgery;
- MBP was not conducted due to ileus or patient refusal;
- Enough data was not available;
- Colorectal resection was performed due to benign disease;
- The procedure was accompanied by other procedures that had the potential to contaminate the incision, such as cholecystectomy or appendectomy;
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 |
|---|---|---|
| Oral antibiotics ( Streptomycin ,metronidazole )Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. Streptomycin 1g plus metronidazole 0.2g was prescribed 3 times a day for 3 days before surgery in the OA+MBP group patients. | Drug | OA+MBP group |
Primary outcome
SSIs incidence
Time frame: up to 30 days postoperatively
Surgical site infection incidence
1 secondary outcome
length of hospital stays
Time frame: up to 3 months posteroperatively
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 6 Feb 2020.
- Derived from this study: PubMed 32046725Lei P, Ruan Y, Yang X, Wu J, Hou Y, Wei H, Chen T. Preoperative mechanical bowel preparation with oral antibiotics reduces surgical site infection after elective colorectal surgery for malignancies: results of a propensity matching analysis. World J Surg Oncol. 2020 Feb 11;18(1):35. doi: 10.1186/s12957-020-1804-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection and Colorectal Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 6 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 6 Feb 2020. 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?
SSIs incidence (time frame: up to 30 days postoperatively). 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 NCT04258098, 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 6 Feb 2020.