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Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.
The aim of the study is to investigate whether the addition of oral antibiotics to Mechanical Bowel Preparation (MBP) prior to colorectal cancer surgical procedures reduce the superfical and deep surgical site (SSI) infectious complications. The study is prospective and is designed in a randomized single-blinded controlled fashion. It is taking place at one academic surgical unit of Athens Medical School, located at a tertiary referal institution. Patients scheduled to undergo an elective surgical resection for colon or rectal cancer will be allocated to either formal MBP the day before surgery or a combined MBP with administration of oral antibiotics. Exclusion criteria are the following: emergency surgery, obstructive or perforated cancer, patients intolerance to bowel preparation regimen and allergies to orally administered antibiotics.
Intervention arms: Patients will be randomised into two groups, concealed from the treating surgeon.
Group A:
Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
Group B:
MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours.
Outcome measures: The primary end point is surgical site infection (SSI), including (i) superficial wound infection, (ii) deep wound infection, and (iii) intrabdominal infection (contaminated fluid or pus collection) within 30 days of the procedure (decrease 3% in the rate) Secondary measures: Anastomotic leaks, other surgical and non-surgical compliactions, hospital length of stay, readmission rate, patients' preparation tolerance, preparation regimens side-effects, time to beginning of adjuvant treatment for colorectal cancer.
Sample Size: It is estimated that 105 patients per treatment arm are needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bowel Preparation plus antibiotics | Active Comparator | Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) |
|
| Bowel Preparation | Other | Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bowel Preparation plus antibiotics | Other | Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infections | Surgical Site Infections | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leaks | Anastomotic leaks | 30 days |
| Other surgical and non-surgical compliactions | Other surgical and non-surgical compliactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Theodoropoulos | Contact | +306945463593 | georgetheocrs@live.com | |
| Georgia Georgiou | Contact | +306945292510 | georgia_cy@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| George Theodoropoulos | National and Kapodistrian University of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NKUAthens | Recruiting | Athens | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38398474 | Derived | Frountzas M, Michalopoulou V, Georgiou G, Kanata D, Matiatou M, Kimpizi D, Matthaiou G, Spiliotopoulos S, Vouros D, Toutouzas KG, Theodoropoulos GE. The Impact of Mechanical Bowel Preparation and Oral Antibiotics in Colorectal Cancer Surgery (MECCA Study): A Prospective Randomized Clinical Trial. J Clin Med. 2024 Feb 19;13(4):1162. doi: 10.3390/jcm13041162. | |
| 36748942 |
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| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D002400 | Cathartics |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Bowel Preparation | Other | Mechanical Bowel Preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours |
|
| 30 days |
| Hospital length of stay | Hospital length of stay | 30 days |
| Readmission rate | Readmission rate | 30 days |
| Patients' preparation tolerance | Patients' preparation tolerance | 30 days |
| Preparation regimens side-effects | Preparation regimens side-effects | 30 days |
| Time to beginning of adjuvant treatment for colorectal cancer | Time to beginning of adjuvant treatment for colorectal cancer | 60 days |
| 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D003108 | Colonic Diseases |
| D012002 | Rectal Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005765 |
| Gastrointestinal Agents |