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Study on Erythromycin and Neomycin for Preventing Infections After Colorectal Surgery in Patients Undergoing Elective Procedures

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on preventing surgical site infections in patients undergoing planned colorectal surgery. Colorectal surgery involves operations on the colon or rectum, which are parts of the large intestine. Surgical site infections are infections that occur after surgery in the part of the body where the surgery took place. The study aims to find out if taking oral antibiotics before surgery can reduce the risk of these infections.

The trial will use two types of antibiotics: Erythromycin and Neomycin. Erythromycin is a commonly used antibiotic that helps fight bacterial infections, and Neomycin is another antibiotic that works similarly. Both medications will be given in tablet form to be taken by mouth. Some participants in the study will receive these antibiotics, while others will receive a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to determine if taking these antibiotics before surgery, without the need for mechanical bowel preparation (a process to clean out the intestines), can lower the chances of getting a surgical site infection. Participants will be monitored throughout their hospital stay and after surgery to check for any infections or complications. The study will help understand the effectiveness of this approach in reducing infections and improving recovery after colorectal surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, eligibility is confirmed for adult patients aged 18 years or older who are scheduled for elective colon or rectal surgery. This includes laparoscopic, open, or robotic-assisted procedures for benign or malignant conditions.
Step 2
Preoperative medication
Before surgery, patients receive oral antibiotics to reduce the risk of infection at the surgical site. The medications used are erythromycin and neomycin sulphate.
Erythromycin Tablets BP 250mg are administered orally. The specific dosage and frequency are determined by the medical team based on individual patient needs.
Neomycin 500mg Tablets are also administered orally. The dosage and frequency are similarly tailored to each patient.
Step 3
Surgery
The scheduled elective colorectal surgery is performed. This may involve laparoscopic, open, or robotic-assisted techniques, depending on the specific case.
Step 4
Postoperative monitoring
After surgery, patients are monitored for any signs of surgical site infection, which is the primary focus of the trial.
Secondary observations include other infectious complications, the length of hospital stay, and any postoperative complications classified according to the Clavien Dindo system. Monitoring also includes checking for anastomotic leakage and mortality.
Step 5
Trial completion
The trial is expected to conclude by July 1, 2026. During this period, data on the incidence of surgical site infections and other related outcomes are collected and analyzed.

Who can join the trial?

6 criteria

Patients must be **adults** aged 18 years or older.
Patients should be scheduled for **elective** colon or rectal surgery. Elective means the surgery is planned in advance and not an emergency.
The surgery can be done using different methods: **laparoscopic**, **open**, or **robotic-assisted**. Laparoscopic surgery involves small cuts and a camera to guide the surgery. Open surgery involves a larger cut to access the area. Robotic-assisted surgery uses robotic tools controlled by the surgeon.
The surgery can be for either **benign** or **malignant** disease. Benign means non-cancerous, and malignant means cancerous.
Both **male** and **female** patients can participate.
Patients should not be part of a **vulnerable population**. This means they should not be in a group that might need special protection or care.

Who cannot join the trial?

5 criteria

Patients who are not scheduled for **elective colorectal surgery**. This means surgeries that are planned in advance and not emergency procedures.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a **vulnerable population**. This refers to groups of people who might need special protection or care, such as children, pregnant women, or those with certain disabilities.
Patients who are not able to take **oral antibiotics** before surgery. Oral antibiotics are medicines taken by mouth to prevent or treat infections.
Patients who require **mechanical bowel preparation**. This is a process to clean out the intestines before surgery, usually involving special drinks or medications.

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Verified sites

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Verified
University Hospital Limerick
Limerick, Ireland

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Investigated drugs

Oral Antibiotics are used in this trial to see if they can help prevent infections at the site of surgery. These antibiotics are taken by mouth before the surgery to clean out harmful bacteria from the digestive system. The goal is to reduce the chance of getting an infection after the surgery.

Erythromycin

What is already known about the treatment

Preoperative Oral Antibiotics – This medication is administered orally before surgery, specifically for patients undergoing elective colorectal surgery. It is currently being studied in clinical trials to assess its effectiveness in reducing surgical site infections. The main therapeutic indication is to prevent infections at the site of surgery. The mechanism of action involves targeting and reducing harmful bacteria in the digestive tract, thereby minimizing the risk of infection during and after surgery. It is classified pharmacologically as an antibiotic.

Investigated diseases

Surgical Site Infection – This condition occurs when bacteria infect the area of the body where surgery was performed. It can develop within a few days to a month after surgery. Symptoms may include redness, pain, and swelling at the surgical site, along with possible drainage of pus. The infection can be superficial, affecting only the skin, or deeper, involving tissues under the skin, organs, or implanted material. The progression of the infection can lead to more severe complications if not addressed. It is a common concern in surgeries, particularly in procedures involving the abdomen.