Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis (UMC-Colprep)

The Role of Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Totally Intracorporeal Anastomosis for Colon Cancer: A Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Other: Mechanical Bowel Preparation; Other: No mechanical bowel preparation

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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tran D Huy, PhD, MD; Phone Number: +84909873773; Email: huy.td@umc.edu.vn
• Study Contact Backup: Name: Le M Triet, MD,; Phone Number: +84394202000; Email: triet.lm@umc.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh
    • Ho Chi Minh City, Ho Chi Minh, Vietnam, 70000
      • Recruiting
      • University Medical Center HCMC
      • Contact: Tran D Huy, PhD, MD; Phone Number: +84909873773; Email: huy.td@umc.edu.vn
      • Contact: Email: bstranduchuy@gmail.com
      • Principal Investigator: Tran D Huy, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical Bowel Preparation; Participants receive preoperative mechanical bowel preparation according to institutional protocol prior to undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis.	Other: Mechanical Bowel Preparation; Mechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice.
Active Comparator: No Mechanical Bowel Preparation; Participants undergo laparoscopic right hemicolectomy with intracorporeal anastomosis without preoperative mechanical bowel preparation	Other: No mechanical bowel preparation; No mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Fecal Contamination	Degree of intraoperative fecal contamination assessed during surgery and categorized according to predefined criteria (e.g., none, minimal, moderate, severe).	During surgery
Anastomotic Leakage	Anastomotic leakage occurring within 30 days after surgery, defined clinically or radiologically according to standard diagnostic criteria.	Within 30 days after surgery
Postoperative Ileus	Postoperative ileus defined as delayed return of bowel function requiring prolonged nasogastric decompression or inability to tolerate oral intake.	Within 30 days after surgery
Operative Time	Total operative time measured from skin incision to skin closure, expressed in minutes.	During surgery

Collaborators and Investigators

• Sponsor: University Medical Center Ho Chi Minh City (UMC)
• Investigators: Principal Investigator: Tran D Huy, PhD, MD, University Medical Center HCMC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Colon cancer; Surgical site infection; Mechanical bowel preparation
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Infections; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Wound Infection; Pathological Conditions, Signs and Symptoms; Colonic Neoplasms; Surgical Wound Infection
• Other Study ID Numbers: 442/2025/HĐ-ĐHYD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data underlying the results reported in this study, after de-identification, will be shared.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication and ending 36 months after publication
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding investigator. Data access will be granted following approval of the proposal and signing of a data access agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No