Surgical Site InfectionNCT03856671
Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs
A study testing Neomycin,metronidazole in people with Surgical Site Infection and Postoperative Complications, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Postoperative Complications, Bowel Preparation
- What is being tested?
- Neomycin,metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2019to 31 Mar 2023
- 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
- Older than 18 years old，
- Undergoing laparoscopic colorectal surgery due to malignancy.
Who cannot join
- No elective surgery
- Intra-abdominal infection
- Combination of other infectious surgery such as appendectomy, cholecystomy
- Sever comobidity such as uncontrolled hypertention and diabetes mellitus
- Peritoneal implantation and matastasis
- Radiotherapy history.
Show all 12Show fewer
- Colorectal surgery due to benign lesions
- Allergic to antibiotics or PEG
- Preoperative dermatosis may interfere wound healing
- Long time application of corticosteroid
- Autoimmune disease may affect wound healing
- Patients refuse to enroll
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-Sen university
Guanzhou, Guangdong, 510000
About this study
Official title: Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial
Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Combination of oral antibiotics and mechanical bowel preparation was reported with lower SSIs and LOS in some retrospecitve data analysis, however a prospective randmized controlled trial was absent. Herein, the current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.
Read the detailed description
Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Colonic bacterial flora is the major cause of SSIs after elective colorectal procedures. For more than century, preoperative mechanical bowel preparation (MBP) has been utilized as it could theoretically decrease bacterial load within the surgical field, thus reduce risk of SSIs. Later afterwards with widely application of antibiotics, combination of oral antibiotics (OA) and MBP was conducted by surgeons to further decrease rates of SSIs. But SSIs still occurs despite of forehead mentioned methods, the best bowel preparation mode remains controversial. Since 2005, several RCTs and meta-analysises demonstrated MBP alone was not associated with reduced SSIs compared with no bowel preparation, while postoperative ileus, anastomotic leakage and other complications incidence increased paradoxically. Nevertheless, function of preoperative oral antibiotics remains debated. Recently, combination of oral antibiotics and MBP has been evaluated in several retrospective studies and demonstrated a significant decrease in the rate of SSIs. However, bias existence in these trials may affect result as information was exacted from national database without detailed matching. Herein, current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.
- Conditions
- Surgical Site Infection, Postoperative Complications, Bowel Preparation, Oral Antibiotics, Colorectal Cancer
- Being tested
- Neomycin,metronidazole
- Keywords
- Surgical Site Infection, oral antibiotics, mechanical bowel preparation, laparoscopic surgery
- Medical subject headings
- Surgical Wound Infection, Postoperative Complications, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neomycin,metronidazoleDrug
Orally intake neomycin 1g and metronidazole 0.2g four times before surgery
| Study group | Role | What they receive |
|---|---|---|
| oral antibiotics+mechanical bowel preparation | Experimental | Liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. A combination of neomycin 1g and metronidazole 0.2g every 6 hours was also administrated. Enteroclysis was conduted for patients on surgical morning. Receives: Drug: Neomycin,metronidazole |
| simple mechanical bowel preparation | No intervention | Only liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. Enteroclysis was conduted for patients on surgical morning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection incidence
Include the superficial, deep and organ space infection.
Measured: 30 days after surgery
Secondary outcomes (4)
Antibiotics associated complications
Allergy, antibiotics associated diarrhea
Measured: 30 days after surgery
Length of hospital stay after surgery
Length of hospital stay
Measured: 30 days after surgery
Bowel recovery time
Time interval from surgery to flatus and defecation
Measured: 7 days after surgery
Other posteroperative complications
Ilues, DVT, anastomotic fistula, hemorrhage, pulmonary infection
Measured: 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 posted27 Feb 2019
- Study start17 Jan 2019
- Primary completion30 Dec 2022
- Study completion31 Mar 2023
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 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
- Investigators
- Hongbo Wei, Ph.D, Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856671
- Sponsor's protocol ID
- OAMBP-01
- Status last verified
- Apr 2023
- First submitted
- 25 Feb 2019
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lei P, Jia G, Yang X, Ruan Y, Wei B, Chen T. Region-specific protection effect of preoperative oral antibiotics combined with mechanical bowel preparation before laparoscopic colorectal resection: a prospective randomized controlled trial. Int J Surg. 2023 Oct 1;109(10):3042-3051. doi: 10.1097/JS9.0000000000000569.
PubMed 37702427Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
PubMed 36748942
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03856671
- Acronym / sponsor ID
- OAMBP-01
- Conditions
- Surgical Site Infection, Postoperative Complications, Bowel Preparation, Oral Antibiotics, Colorectal Cancer
- Keywords
- Surgical Site Infection, oral antibiotics, mechanical bowel preparation, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 27 Feb 2019 (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 infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Combination of oral antibiotics and mechanical bowel preparation was reported with lower SSIs and LOS in some retrospecitve data analysis, however a prospective randmized controlled trial was absent. Herein, the current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.
Detailed description
Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Colonic bacterial flora is the major cause of SSIs after elective colorectal procedures. For more than century, preoperative mechanical bowel preparation (MBP) has been utilized as it could theoretically decrease bacterial load within the surgical field, thus reduce risk of SSIs. Later afterwards with widely application of antibiotics, combination of oral antibiotics (OA) and MBP was conducted by surgeons to further decrease rates of SSIs. But SSIs still occurs despite of forehead mentioned methods, the best bowel preparation mode remains controversial. Since 2005, several RCTs and meta-analysises demonstrated MBP alone was not associated with reduced SSIs compared with no bowel preparation, while postoperative ileus, anastomotic leakage and other complications incidence increased paradoxically. Nevertheless, function of preoperative oral antibiotics remains debated. Recently, combination of oral antibiotics and MBP has been evaluated in several retrospective studies and demonstrated a significant decrease in the rate of SSIs. However, bias existence in these trials may affect result as information was exacted from national database without detailed matching. Herein, current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral antibiotics+mechanical bowel preparation | Experimental | Drug: Neomycin,metronidazoleLiquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. A combination of neomycin 1g and metronidazole 0.2g every 6 hours was also administrated. Enteroclysis was conduted for patients on surgical morning. |
| simple mechanical bowel preparation | No intervention | –Only liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. Enteroclysis was conduted for patients on surgical morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years old，
- Undergoing laparoscopic colorectal surgery due to malignancy.
Key exclusion criteria (12 listed)
- No elective surgery
- Intra-abdominal infection
- Combination of other infectious surgery such as appendectomy, cholecystomy
- Sever comobidity such as uncontrolled hypertention and diabetes mellitus
- Peritoneal implantation and matastasis
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 |
|---|---|---|
| Neomycin,metronidazoleOrally intake neomycin 1g and metronidazole 0.2g four times before surgery | Drug | oral antibiotics+mechanical bowel preparation |
Primary outcome
Surgical site infection incidence
Time frame: 30 days after surgery
Include the superficial, deep and organ space infection.
4 secondary outcomes
Antibiotics associated complications
Time frame: 30 days after surgery
Length of hospital stay after surgery
Time frame: 30 days after surgery
Bowel recovery time
Time frame: 7 days after surgery
Other posteroperative complications
Time frame: 30 days after surgery
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 5 Apr 2023.
- Derived from this study: PubMed 37702427Lei P, Jia G, Yang X, Ruan Y, Wei B, Chen T. Region-specific protection effect of preoperative oral antibiotics combined with mechanical bowel preparation before laparoscopic colorectal resection: a prospective randomized controlled trial. Int J Surg. 2023 Oct 1;109(10):3042-3051. doi: 10.1097/JS9.0000000000000569.
- Derived from this study: PubMed 36748942Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Hongbo Wei, Ph.D study director
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neomycin,metronidazole in people with Surgical Site Infection and Postoperative Complications, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 2 inclusion and 12 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 5 Apr 2023. 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 China. 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.
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?
Surgical site infection incidence (time frame: 30 days after surgery). 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 NCT03856671, 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 5 Apr 2023.