Colon Cancer
Conditions
Keywords
Colon cancer, Surgical site infection, Mechanical bowel preparation
Brief summary
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.
Detailed description
This randomized controlled trial evaluates the role of mechanical bowel preparation (MBP) in patients undergoing laparoscopic right hemicolectomy with totally intracorporeal anastomosis for colon cancer. Participants are randomly assigned to receive MBP or no MBP prior to surgery using a web-based minimization algorithm. The primary endpoint is surgical site infection within 30 days. Secondary outcomes include intraoperative contamination, anastomotic leakage, postoperative ileus, operative time, and recovery parameters. The study aims to determine whether MBP improves surgical outcomes in this setting.
Interventions
Mechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice.
No mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care.
Sponsors
University Medical Center Ho Chi Minh City (UMC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Participants are aware of their assigned intervention due to the nature of mechanical bowel preparation. The operating surgeons (investigators) are blinded to group allocation. Allocation is concealed using a centralized web-based randomization system, and group assignments are accessible only to designated research staff responsible for preoperative preparation. The allocation is not disclosed to the surgical team prior to surgery. Standardized perioperative protocols are applied to minimize potential bias.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: mechanical bowel preparation (MBP) or no mechanical bowel preparation prior to surgery. Randomization will be performed using a web-based system with a minimization algorithm to ensure balance between groups based on age (≤60 vs \>60 years), sex, and cancer stage (II vs III). Each participant will receive only one assigned intervention, and no crossover between groups will occur.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * Recurrent colon cancer after prior surgery * Synchronous primary malignancies in other organs * Patients undergoing palliative surgery or surgery for tumor-related complications (non-curative intent) * Inability to complete follow-up or be contacted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (SSI) | Within 30 days after surgery | Surgical site infection (SSI) within 30 days after surgery, defined according to the Centers for Disease Control and Prevention (CDC) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Fecal Contamination | During surgery | Degree of intraoperative fecal contamination assessed during surgery and categorized according to predefined criteria (e.g., none, minimal, moderate, severe). |
| Anastomotic Leakage | Within 30 days after surgery | Anastomotic leakage occurring within 30 days after surgery, defined clinically or radiologically according to standard diagnostic criteria. |
| Postoperative Ileus | Within 30 days after surgery | Postoperative ileus defined as delayed return of bowel function requiring prolonged nasogastric decompression or inability to tolerate oral intake. |
| Operative Time | During surgery | Total operative time measured from skin incision to skin closure, expressed in minutes. |
Countries
Vietnam
Contacts
CONTACTTran D Huy, PhD, MD
CONTACTLe M Triet, MD,
PRINCIPAL_INVESTIGATORTran D Huy, PhD, MD
University medical center HCMC
Outcome results
None listed