Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis

ConditionColon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Ho Chi Minh City (UMC)

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mechanical Bowel Preparation

    Other intervention

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

  • No mechanical bowel preparation

    Other intervention

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

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Mechanical Bowel PreparationExperimental treatment 1 intervention
Group B: No Mechanical Bowel PreparationActive comparator 1 intervention

Trial outcomes

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.

Time frame
Within 30 days after surgery

Secondary outcomes

1

Intraoperative Fecal Contamination

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

Time frame
During surgery
2

Anastomotic Leakage

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

Time frame
Within 30 days after surgery
3

Postoperative Ileus

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

Time frame
Within 30 days after surgery
4

Operative Time

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

Time frame
During surgery

Other outcomes

Sponsors and contacts

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