Infections

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Communicable Diseases

Surgical Wound Infection

Postoperative Complications

Surgical Wound

Wound Infection

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Metronidazole

Antibiotics, Antitubercular

Neomycin

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

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.

Only liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. Enteroclysis was conduted for patients on surgical morning.

Orally intake neomycin 1g and metronidazole 0.2g four times before surgery

Neomycin,metronidazole

Hongbo Wei, Ph.D

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.

No masking is to conducted in the current study.

Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial

Include the superficial, deep and organ space infection.

Time interval from surgery to flatus and defecation

Ilues, DVT, anastomotic fistula, hemorrhage, pulmonary infection

Third Affiliated Hospital, Sun Yat-Sen University

Professor

Neoplasms

Digestive System Diseases

Adenocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

Iron

fiberless diet starting 2 days before surgery. Drugs containing iron and coal plant will be stopped. Free breakfast the day before surgery. Lunch: meat broth and white meat. From 16 p. m. to 20 p. m. assumption of Polyethylene Glycol Macrogol 70 mg per 1 liter of water 4 times (1L each hour). A bowel enema (2L, glycerin 5%) will be administered at 6 a. m. the day of surgery.

mechanical bowel preparation

fiberless diet starting 2 days before surgery. Drugs containing iron and coal plant will be stopped. Free breakfast the day before surgery. Lunch: meat broth and white meat. Dinner: meat broth and fasting starting from midnight. A bowel single enema (2L, glycerin 5%) will be administered at 6 a. m. the day of surgery.

enema

Bruno Andreoni, MD

Roberto Biffi, MD

Emilio Bertani, MD

The purpose of this study is to evaluate mechanical bowel preparation (MBP) with polyethylene glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal resection for malignancy.

Surgical site infections (SSI) in colorectal surgery (anastomotic leakage, wound infection, intraabdominal abscess) are associated with increased mortality, postoperative hospital stay and costs. From a recent metanalysis and randomized clinical trial there is the emerging evidence that mechanical bowel preparation (MBP) before elective colorectal surgery is not associated with reduction of SIS, although it causes high discomfort for patients. On the same way other more recent studies show that MBP may cause an higher incidence of SIS, and that MBP may alter the bowel mucosa morphology. Other Authors report an increased incidence of anastomotic leakage requiring surgery for patients undergoing a single preoperative phosphate enema whereas but an higher cardiovascular mortality for patients undergoing MBP. Two recent studies do not clarify the usefulness of MBP for reducing SIS after colorectal surgery and one stage anastomosis. For these reasons a more precise understanding of the relationship between MBP and SIS could increase patients satisfaction and decrease unnecessary procedures and costs. At this point MBP represent the clinical standard for patients undergoing elective colorectal surgery at the European Institute of Oncology.

Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma

Effect of Mechanical Bowel Preparation With Polyethylene Glycol Plus Bowel Enema (Glycerine 5%) vs Bowel Enema Alone in Patients Candidates to Colorectal Resection for Malignancy. Prospective, Randomized Clinical Trial

European Institute of Oncology

Colonic Neoplasms

Gastrointestinal Agents

Herbal and Botanical

Laxatives

Cathartics

Cola

mechanical bowel preparation with polyethylene glycol one day prior to surgery

polyethylene glycol

No Preparation

Prakash Kurumboor, MS, MCh

Pramil K, MS

This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery. In this trial patients with left sided colon and rectal tumors were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome

In this prospective randomized trial,patients were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome following elective laparoscopic surgery for left sided colon and rectal tumors. Randomization is done from the out -patient department at the time of admission, using random numbers from a computer generated list from a sealed envelope method.

Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with polyethylene glycol one day prior to surgery.

Both groups will have the scheduled laparoscopic colonic resections. Use of diverting stoma is left to the discretion of the operating surgeon. Cases that needed a diverting stoma, will be analyzed separately.

Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

A Randomised Controlled Trial On Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation In Elective Laparoscopic Surgery For Left Sided Colonic Tumours

superficial and deep surgical site infection

intraoperative assessment of tumor site, extend, operative time, intraoperative contamination

Any intervention radiological or surgical due to procedure related complications

admission to hospital after discharge due to any reasons

PVS Memorial Hospital

Chief GI Surgeon

Cefotaxime

Cefoxitin

Rifaximin

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)

Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)

Bowel Preparation plus antibiotics

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

Bowel Preparation

George Theodoropoulos

Georgia Georgiou

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.

Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery

Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer

Other surgical and non-surgical compliactions

Time to beginning of adjuvant treatment for colorectal cancer

National and Kapodistrian University of Athens

Associate Professor

Anastomotic Leak

Rectal Neoplasms

bowel preparation

no preparation bowel

PANIS Yves, Pr

The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation

Preoperative mechanical bowel preparation (MBP) (i.e. including oral laxatives, retrograde enemas and/or oral diet before surgery) is the standard practice in colorectal surgery. The importance of MBP in preventing anastomotic leakage and infectious morbidity after elective colorectal surgery has been a dogma among surgeons for many years. The main reason is the belief that postoperative complications is related to septic bowel content. However, there is a paucity of scientific evidence demonstrating the efficacy of this practice in reducing morbidity. Moreover, potential disadvantages of MBP include the requirement for a longer preoperative duration of admission before surgery, its time consuming nature, being expensive and unpleasant for the patient and expose the early population to the particular risk of fluid and electrolyte imbalance .At least eight randomized clinical trials and two meta-analyses failed to show any superiority of MBP in colorectal surgery. On the contrary, they demonstrated that preparation might lead to an increased rate of septic complications. Such initial dates lead surgeons to re-evaluate their current clinical practice in colonic surgery. But to dates, these findings cannot finally be applied to rectal surgery because of insufficient dates. To date, no study about MBP was specifically devoted to rectal surgery. Moreover, it is currently admitted that the risk of septic complications following rectal resection, as a result of the well-known risk factors, is higher than after colonic preparation. It is the reason why most of the colorectal surgeons consider that a no preparation regimen in rectal cancer surgery could represent an additive risk factor for postoperative morbidity.

Rectal Cancer Surgery Without Mechanical Bowel Preparation

ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

Assistance Publique - Hôpitaux de Paris

Cécile Jourdain

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Mechanical Bowel Preparation and Oral Antibiotics

Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)

Oral Antibiotics

Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)

Placebo

Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Mechanical Bowel Preparation

Laura Koskenvuo, MD, PhD

Anna Lepistö, MD, PhD

Ville Sallinen, MD, PhD

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial

Individual deidentified participant data will not be available for sharing. Study protocol will be available.

Difference in quality of life between baseline and 1 year measured using SF-36

Difference in quality of life between baseline and 1 year measured using QLQ-C30

Difference in quality of life between baseline and 1 year measured using QLQ-CR29

Difference in quality of life between baseline and 1 year measured using LARS

Surgical site infection as defined by CDC

Patients receiving adjuvant therapy divided by patients needing adjuvant therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs	NCT03856671	Surgical Site I... Postoperative C... Bowel Preparati... Oral Antibiotic... Colorectal Canc...	Neomycin,metron...	18 Years -	Third Affiliated Hospital, Sun Yat-Sen University
Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma	NCT00940030	Colorectal Canc...	mechanical bowe... enema	18 Years - 80 Years	European Institute of Oncology
Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery	NCT01797770	Rectal Cancer Colon Cancer	polyethylene gl... No Preparation	25 Years - 75 Years	PVS Memorial Hospital
Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery	NCT03563586	Antibiotic Bowel Cancer Colorectal Canc... Surgical Site I...	Bowel Preparati... Bowel Preparati...	18 Years - 90 Years	National and Kapodistrian University of Athens
Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery	NCT03563586	Antibiotic Bowel Cancer Colorectal Canc... Surgical Site I...	Bowel Preparati... Bowel Preparati...	18 Years - 90 Years	National and Kapodistrian University of Athens
Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery	NCT01797770	Rectal Cancer Colon Cancer	polyethylene gl... No Preparation	25 Years - 75 Years	PVS Memorial Hospital
Rectal Cancer Surgery Without Mechanical Bowel Preparation	NCT00554892	Patients With R...	bowel preparati... no preparation ...	18 Years -	Assistance Publique - Hôpitaux de Paris
Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery	NCT04281667	Rectal Adenocar... Rectum Neoplasm Rectum Carcinom... Colorectal Canc... Colorectal Neop... Colorectal Carc... Surgical Site I... Surgery--Compli...	Oral Antibiotic... Placebo Mechanical Bowe...	18 Years -	Helsinki University Central Hospital

Spots Global Cancer Trial Database for mechanical bowel preparation