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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical Bowel Preparation | Experimental | Participants receive preoperative mechanical bowel preparation according to institutional protocol prior to undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis. |
|
| No Mechanical Bowel Preparation | Active Comparator | Participants undergo laparoscopic right hemicolectomy with intracorporeal anastomosis without preoperative mechanical bowel preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Bowel Preparation | Other | Mechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tran D Huy, PhD, MD | Contact | +84909873773 | huy.td@umc.edu.vn | |
| Le M Triet, MD, | Contact | +84394202000 | triet.lm@umc.edu.vn |
| Name | Affiliation | Role |
|---|---|---|
| Tran D Huy, PhD, MD | University medical center HCMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center HCMC | Recruiting | Ho Chi Minh City | Ho Chi Minh | 70000 | Vietnam |
Individual participant data underlying the results reported in this study, after de-identification, will be shared.
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Data will be available beginning 6 months after publication and ending 36 months after publication
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2025 | Apr 16, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2025 | Apr 16, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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.
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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.
| No mechanical bowel preparation | Other | No mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care. |
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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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |