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CompletedNCT04258098Updated Feb 6, 2020

Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs: A Propensity Analysis

An observational study in Surgical Site Infection and Colorectal Cancer, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Completed. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
806
Sex
All
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Study 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. 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.

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Conditions studied

  • Surgical Site Infection
  • Colorectal Cancer
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 806 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Patient underwent elective colorectal resection to treat a malignancy;
  2. Patient baseline characteristics and operative information were available;
  3. MBP (mechanical bowel preparation) was performed before surgery, with or without OA (oral antibiotics).

Exclusion criteria

Exclusion Criteria:

  1. Emergency surgery;
  2. MBP was not conducted due to ileus or patient refusal;
  3. Enough data was not available;
  4. Colorectal resection was performed due to benign disease;
  5. The procedure was accompanied by other procedures that had the potential to contaminate the incision, such as cholecystectomy or appendectomy;
  6. Patients underwent neoadjuvant radiotherapy before surgery.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
806 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

Interventions

  • DrugOral 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.

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What researchers measure

Primary outcomes

  1. SSIs incidence

    Surgical site infection incidence

    Time frame: up to 30 days postoperatively

Secondary outcomes

  1. length of hospital stays

    length of hospital stays after colorectal surgeries

    Time frame: up to 3 months posteroperatively

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04258098
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Responsible party
Hongbo Wei (Prof., Third Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Feb 6, 2020
Start date
Jan 1, 2011
Primary completion
Dec 31, 2017
Completion
May 12, 2019
Last update
Feb 6, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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