Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis

NCT07546565 | Recruiting

• 1 other identifier: 442/2025/HĐ-ĐHYD
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

Colon cancer; Surgical site infection; Mechanical bowel preparation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intraoperative Fecal Contamination

  During surgery

• Anastomotic Leakage

  Within 30 days after surgery

• Postoperative Ileus

  Within 30 days after surgery

• Operative Time

  During surgery

Study Arms (2)

Mechanical Bowel Preparation

EXPERIMENTAL

Participants receive preoperative mechanical bowel preparation according to institutional protocol prior to undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis.

Other: Mechanical Bowel Preparation

No Mechanical Bowel Preparation

ACTIVE COMPARATOR

Participants undergo laparoscopic right hemicolectomy with intracorporeal anastomosis without preoperative mechanical bowel preparation

Other: No mechanical bowel preparation

Interventions

Mechanical Bowel Preparation OTHER

Mechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice.

Mechanical Bowel Preparation

No mechanical bowel preparation OTHER

No mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care.

No Mechanical Bowel Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

University Medical Center HCMC

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tran D Huy, PhD, MD

  University medical center HCMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tran D Huy, PhD, MD

CONTACT

+84909873773; huy.td@umc.edu.vn

Le M Triet, MD,

CONTACT

+84394202000; triet.lm@umc.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Colorectal surgeon

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 6 months after publication and ending 36 months after publication
• 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.

Locations

VN (1)