Colon CancerUMC-ColprepNCT07546565
Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis
A study testing Mechanical Bowel Preparation and No mechanical bowel preparation in people with Colon Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Mechanical Bowel Preparation and No mechanical bowel preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University Medical Center HCMC
Ho Chi Minh City, Ho Chi Minh, 70000
Tran D Huy, PhD, MD, +84909873773, huy.td@umc.edu.vn
bstranduchuy@gmail.com
About this study
Official title: The Role of Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Totally Intracorporeal Anastomosis for Colon Cancer: A Randomized Controlled 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.
Read more
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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- Mechanical Bowel Preparation, No mechanical bowel preparation
- Keywords
- Colon cancer, Surgical site infection, Mechanical bowel preparation
- Medical subject headings
- Colonic Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Bowel PreparationOther
Mechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice.
No mechanical bowel preparationOther
No mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Bowel Preparation | Experimental | Participants receive preoperative mechanical bowel preparation according to institutional protocol prior to undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis. Receives: Other: Mechanical Bowel Preparation |
| No Mechanical Bowel Preparation | Active comparator | Participants undergo laparoscopic right hemicolectomy with intracorporeal anastomosis without preoperative mechanical bowel preparation Receives: Other: No mechanical bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after surgery
Secondary outcomes (4)
Intraoperative Fecal Contamination
Degree of intraoperative fecal contamination assessed during surgery and categorized according to predefined criteria (e.g., none, minimal, moderate, severe).
Measured: During surgery
Anastomotic Leakage
Anastomotic leakage occurring within 30 days after surgery, defined clinically or radiologically according to standard diagnostic criteria.
Measured: 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.
Measured: Within 30 days after surgery
Operative Time
Total operative time measured from skin incision to skin closure, expressed in minutes.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trần Đức Huy, University Medical Center Ho Chi Minh City (UMC)
- Investigators
- Tran D Huy, PhD, MD, Principal investigator, University medical center HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546565
- Sponsor's protocol ID
- 442/2025/HĐ-ĐHYD
- Acronym
- UMC-Colprep
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in this study, after de-identification, will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Totally Intracorporeal Anastomosis for Colon Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07546565
- Acronym / sponsor ID
- UMC-Colprep / 442/2025/HĐ-ĐHYD
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, Surgical site infection, Mechanical bowel preparation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Bowel Preparation | Experimental | Other: Mechanical Bowel PreparationParticipants receive preoperative mechanical bowel preparation according to institutional protocol prior to undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis. |
| No Mechanical Bowel Preparation | Active comparator | Other: No mechanical bowel preparationParticipants undergo laparoscopic right hemicolectomy with intracorporeal anastomosis without preoperative mechanical bowel preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Bowel PreparationMechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice. | Other | Mechanical Bowel Preparation |
| No mechanical bowel preparationNo mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care. | Other | No Mechanical Bowel Preparation |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in this study, after de-identification, will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tran D Huy, PhD, MD principal investigator
University medical center HCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Bowel Preparation and No mechanical bowel preparation in people with Colon Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tran D Huy, PhD, MD (+84909873773, huy.td@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (SSI) (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.