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NCT Number: NCT07546565

Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center HCMC

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

Location status: Recruiting

Location contact

Tran D Huy, PhD, MD

CONTACT

[email protected]

+84909873773

Tran D Huy, PhD, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical Bowel Preparation

Other

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

No mechanical bowel preparation

Other

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

Primary outcomes

  1. Surgical Site Infection (SSI)

    Time frame: 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 outcomes

  1. Intraoperative Fecal Contamination

    Time frame: During surgery

    Degree of intraoperative fecal contamination assessed during surgery and categorized according to predefined criteria (e.g., none, minimal, moderate, severe).

  2. Anastomotic Leakage

    Time frame: Within 30 days after surgery

    Anastomotic leakage occurring within 30 days after surgery, defined clinically or radiologically according to standard diagnostic criteria.

  3. Postoperative Ileus

    Time frame: Within 30 days after surgery

    Postoperative ileus defined as delayed return of bowel function requiring prolonged nasogastric decompression or inability to tolerate oral intake.

  4. Operative Time

    Time frame: During surgery

    Total operative time measured from skin incision to skin closure, expressed in minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Le M Triet, MD,

CONTACT

[email protected]

+84394202000

Tran D Huy, PhD, MD

CONTACT

[email protected]

+84909873773

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

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

Acronym: UMC-Colprep

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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