Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis

Official title

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

Overview

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

• Other Mechanical Bowel Preparation
  Mechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice.
• Other No mechanical bowel preparation
  No mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care.

Primary outcome measures

• Surgical Site Infection (SSI) [Time frame: Within 30 days after surgery]

Secondary outcome measures (4)

• Intraoperative Fecal Contamination [Time frame: During surgery]
• Anastomotic Leakage [Time frame: Within 30 days after surgery]
• Postoperative Ileus [Time frame: Within 30 days after surgery]
• Operative Time [Time frame: During surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Vietnam · 1 center

• University Medical Center HCMC — Ho Chi Minh City

Identifiers

NCT: NCT07546565 · 442/2025/HĐ-ĐHYD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗