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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neomycin,metronidazole | Drug | Orally intake neomycin 1g and metronidazole 0.2g four times before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection incidence | Include the superficial, deep and organ space infection. | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotics associated complications | Allergy, antibiotics associated diarrhea | 30 days after surgery |
| Length of hospital stay after surgery | Length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongbo Wei, Ph.D | Third Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-Sen university | Guanzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37702427 | Derived | 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. | |
| 36748942 | Derived |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D011183 | Postoperative Complications |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009355 | Neomycin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009593 | Nitroimidazoles |
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No masking is to conducted in the current study.
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| 30 days after surgery |
| Bowel recovery time | Time interval from surgery to flatus and defecation | 7 days after surgery |
| Other posteroperative complications | Ilues, DVT, anastomotic fistula, hemorrhage, pulmonary infection | 30 days after surgery |
| Willis 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. |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009574 |
| Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |