About this trial
This study is a randomized controlled trial conducted at University Medical Center Ho Chi Minh City to evaluate the role of mechanical bowel preparation (MBP) in patients undergoing laparoscopic right hemicolectomy with totally intracorporeal anastomosis for colon cancer.
Mechanical bowel preparation is commonly used before colorectal surgery to reduce bowel contents and potentially decrease the risk of postoperative infections. However, its benefit remains controversial, particularly in intracorporeal anastomosis, where intra-abdominal contamination may influence surgical outcomes.
In this study, eligible patients will be randomly assigned to one of two groups: with or without mechanical bowel preparation before surgery. The study aims to compare intraoperative events, postoperative complications, and recovery outcomes between the two groups.
The primary outcome is the rate of surgical site infection (SSI) within 30 days after surgery. Secondary outcomes include intraoperative fecal contamination, anastomotic leakage, postoperative ileus, operative time, and recovery parameters such as time to first bowel movement and length of hospital stay.
The findings of this study are expected to clarify the role of mechanical bowel preparation in reducing postoperative infections and improving surgical outcomes in patients undergoing laparoscopic right hemicolectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with colon cancer stage I-III according to the TNM classification
Patients undergoing elective right hemicolectomy or extended right hemicolectomy with totally intracorporeal anastomosis at University Medical Center Ho Chi Minh City
Postoperative histopathological confirmation of adenocarcinoma
Disqualifiers
Patients undergoing emergency surgery
Contraindications to mechanical bowel preparation (e.g., bowel obstruction, subobstruction, bowel perforation, or peritumoral abscess)
Contraindications to laparoscopic surgery (American Society of Anesthesiologists [ASA] physical status IV or V) or to intracorporeal anastomosis
Distant metastasis at the time of surgery (stage IV according to the TNM classification)
Trial design
Parallel
Treatments tested in this trial
Mechanical Bowel Preparation
Other interventionMechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice.
No mechanical bowel preparation
Other interventionNo mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care.
Treatment groups
Trial outcomes
Primary outcomes
Surgical Site Infection (SSI)
Surgical site infection (SSI) within 30 days after surgery, defined according to the Centers for Disease Control and Prevention (CDC) criteria.
Secondary outcomes
Intraoperative Fecal Contamination
Degree of intraoperative fecal contamination assessed during surgery and categorized according to predefined criteria (e.g., none, minimal, moderate, severe).
Anastomotic Leakage
Anastomotic leakage occurring within 30 days after surgery, defined clinically or radiologically according to standard diagnostic criteria.
Postoperative Ileus
Postoperative ileus defined as delayed return of bowel function requiring prolonged nasogastric decompression or inability to tolerate oral intake.
Operative Time
Total operative time measured from skin incision to skin closure, expressed in minutes.
Sponsors and contacts
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