Esophageal CancerNCT05523960
Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery
A study testing No MBP in people with Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The study type was designed as a prospective multicenter randomized controlled study. The patients will be divided into intervention group and control group, 281 patients were needed for each group and 562 patients would be needed totally to show this difference. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- No MBP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion.
Who cannot join
- need for emergency surgery;
- previous chronic constipation or diarrhea;
- previous abdominal surgery; need for colonic reconstruction;
- other indications for mechanical preparation or contraindications;
- allergy to drugs used in the trial (polyethylene glycol)
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery: a Multi-center, Randomized, Parallel, Single-blinded Trial
The study type was designed as a prospective multicenter randomized controlled study. The patients will be divided into intervention group and control group, 281 patients were needed for each group and 562 patients would be needed totally to show this difference. Due to a possible loss of 14%, the final sample size was calculated to be 652 patients. The intervention group will not implement mechanical bowel preparation(MBP) before surgery; the control group will receive routine preoperative MBP for oral administration of compound polyethylene glycol electrolyte powder and fasting water. Perioperative complications, intestinal recovery speed and quality of life will be investigated between the two groups.
Read the detailed description
Patients allocated to MBP will be instructed by the study nurse to prepare their bowel mechanically by drinking 3~4L of polyethylene glycol (Polyethylene Glycol Electrolytes Powder 68.56g; Shenzhen, China) with water before 6pm in the evening the day before the surgery. Patients allocated to NBP were instructed to not prepare the bowel. The receipt of the allocated intervention will be controlled by study nurse asking the patients on the morning of the surgery whether they had acted as instructed by the allocation. This information will be also concealed from treating physicians and surgeons, data collectors, and data analysts, until the primary and secondary outcomes were analyzed. All patients will follow the ERAS protocol. Prophylactic intravenous antibiotics (cephamycin 1000mg) will be given to all patients 30 minutes before skin incision. The prophylactic intravenous antibiotics will re-administered if the surgery lasted longer than 3h from the first antibiotic dose. Surgical skin preparation will involve taking a bath well the night before operation without shaving the hair. Just before skin incision, the area will then washed three times with denatured 80% alcohol to left to dry.
- Conditions
- Esophageal Cancer
- Being tested
- No MBP
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No MBPProcedure or surgery
No mechanical bowel preparation before operation
| Study group | Role | What they receive |
|---|---|---|
| NBP group | Experimental | Patients allocated to NBP were instructed to not prepare the bowel. Receives: Procedure: No MBP |
| MBP group | Other | Patients allocated to MBP were instructed by the study nurse to prepare their bowel mechanically by drinking 3~4L of polyethylene glycol (Polyethylene Glycol Electrolytes Powder 68.56g; Shenzhen, China) with water before 6pm in the evening the day before the surgery. Receives: Procedure: No MBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of major complications
A major intraoperative and postoperative complication was defined as a surgical or medical complication with a Clavien-Dindo (CD) grade of Ⅱor higher (this five-grade system includes sub-grades in grades Ⅲ and Ⅳ, and higher grades indicate more life-threatening complications) according to Esophagectomy Complications Consensus Group (ECCG)
Measured: during surgery orwithin 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Jan 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523960
- Sponsor's protocol ID
- NCC2020C-511
- Status last verified
- May 2024
- First submitted
- 29 Aug 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery: a Multi-center, Randomized, Parallel, Single-blinded Trial
- ClinicalTrials.gov ID
- NCT05523960
- Acronym / sponsor ID
- NCC2020C-511
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 1 Sep 2022 (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.
The study type was designed as a prospective multicenter randomized controlled study. The patients will be divided into intervention group and control group, 281 patients were needed for each group and 562 patients would be needed totally to show this difference. Due to a possible loss of 14%, the final sample size was calculated to be 652 patients. The intervention group will not implement mechanical bowel preparation(MBP) before surgery; the control group will receive routine preoperative MBP for oral administration of compound polyethylene glycol electrolyte powder and fasting water. Perioperative complications, intestinal recovery speed and quality of life will be investigated between the two groups.
Detailed description
Patients allocated to MBP will be instructed by the study nurse to prepare their bowel mechanically by drinking 3~4L of polyethylene glycol (Polyethylene Glycol Electrolytes Powder 68.56g; Shenzhen, China) with water before 6pm in the evening the day before the surgery. Patients allocated to NBP were instructed to not prepare the bowel. The receipt of the allocated intervention will be controlled by study nurse asking the patients on the morning of the surgery whether they had acted as instructed by the allocation. This information will be also concealed from treating physicians and surgeons, data collectors, and data analysts, until the primary and secondary outcomes were analyzed. All patients will follow the ERAS protocol. Prophylactic intravenous antibiotics (cephamycin 1000mg) will be given to all patients 30 minutes before skin incision. The prophylactic intravenous antibiotics will re-administered if the surgery lasted longer than 3h from the first antibiotic dose. Surgical skin preparation will involve taking a bath well the night before operation without shaving the hair. Just before skin incision, the area will then washed three times with denatured 80% alcohol to left to dry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBP group | Experimental | Procedure: No MBPPatients allocated to NBP were instructed to not prepare the bowel. |
| MBP group | Other | Procedure: No MBPPatients allocated to MBP were instructed by the study nurse to prepare their bowel mechanically by drinking 3~4L of polyethylene glycol (Polyethylene Glycol Electrolytes Powder 68.56g; Shenzhen, China) with water before 6pm in the evening the day before the surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion.
Key exclusion criteria (5 listed)
- need for emergency surgery;
- previous chronic constipation or diarrhea;
- previous abdominal surgery; need for colonic reconstruction;
- other indications for mechanical preparation or contraindications;
- allergy to drugs used in the trial (polyethylene glycol)
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 |
|---|---|---|
| No MBPNo mechanical bowel preparation before operation | Procedure or surgery | MBP group, NBP group |
Primary outcome
the rate of major complications
Time frame: during surgery orwithin 30 days after surgery
A major intraoperative and postoperative complication was defined as a surgical or medical complication with a Clavien-Dindo (CD) grade of Ⅱor higher (this five-grade system includes sub-grades in grades Ⅲ and Ⅳ, and higher grades indicate more life-threatening complications) according to Esophagectomy Complications Consensus Group (ECCG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No MBP in people with Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 7 May 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of major complications (time frame: during surgery orwithin 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 7 May 2024.