Bowel cleaning versus no bowel cleaning before laparoscopic right colectomy with internal (intracorporeal) anastomosis
The Role of Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Totally Intracorporeal Anastomosis for Colon Cancer: A Randomized Controlled Trial
This trial will test whether doing a mechanical bowel preparation (bowel cleaning) before elective laparoscopic right hemicolectomy with intracorporeal anastomosis for stage I–III colon cancer changes surgical site infection rates and recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) Academic / other |
| Locations | 1 site (Ho Chi Minh City, Ho Chi Minh) |
| Trial ID | NCT07546565 on ClinicalTrials.gov |
What this trial studies
This single-center randomized trial at University Medical Center Ho Chi Minh City assigns eligible patients to either receive mechanical bowel preparation (MBP) or not before elective laparoscopic right hemicolectomy with totally intracorporeal anastomosis using a web-based minimization algorithm. The primary endpoint is surgical site infection within 30 days after surgery, and secondary endpoints include intraoperative contamination, anastomotic leakage, postoperative ileus, operative time, and recovery metrics. Patients with stage I–III colon adenocarcinoma undergoing elective curative surgery are enrolled, while those with emergency surgery, stage IV disease, or contraindications to MBP are excluded. The trial aims to clarify whether MBP meaningfully alters intraoperative contamination and short-term postoperative outcomes in the intracorporeal anastomosis setting.
Who should consider this trial
Good fit: Ideal candidates are adults with stage I–III colon adenocarcinoma scheduled for elective laparoscopic right hemicolectomy or extended right hemicolectomy with totally intracorporeal anastomosis at University Medical Center HCMC who meet surgical fitness criteria.
Not a fit: Patients unlikely to benefit include those with stage IV or recurrent disease, emergency surgery, contraindications to MBP (bowel obstruction, perforation, peritumoral abscess), inability to tolerate laparoscopic surgery, or who are undergoing palliative procedures.
Why it matters
Potential benefit: If positive, the result could lower surgical site infections and speed recovery or spare patients an unnecessary and unpleasant bowel preparation.
How similar studies have performed: Prior trials of mechanical bowel preparation for colorectal surgery have shown mixed results and benefits remain unclear, and evidence specifically for procedures with intracorporeal anastomosis is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ho Chi Minh City, Ho Chi Minh
- University Medical Center HCMC — Ho Chi Minh City, Ho Chi Minh, Vietnam (Recruiting)
Study contacts
- Principal investigator: Tran D Huy, PhD, MD — University medical center HCMC
- Study coordinator: Tran D Huy, PhD, MD
- Email: huy.td@umc.edu.vn
- Phone: +84909873773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.