Colon CancerPhase 3COLONPREPNCT03475680
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery
A Phase 3 study testing Sennosides colonic preparation, Oral Gentamycin and Oral Ornidazole in people with Colon Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics… 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?
- Sennosides colonic preparation, Oral Gentamycin and Oral Ornidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2018to 23 Mar 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or more
- Scheduled to undergo elective restorative laparoscopic segmental colectomy for colon cancer
- With Signed consent
- And affiliated to the French social security system
Who cannot join
- Emergent surgery
- Scheduled total or subtotal colectomy (defined as a colectomy extended from the right colon to a least the left colonic angle)
- Scheduled transverse colectomy
- Scheduled associated proctectomy
- Scheduled associated concomitant resection of another organ (liver, etc.), except the abdominal wall
- Previous segmental colectomy
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- Associated inflammatory bowel disease
- Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery)
- Patients with known colonization with multidrug-resistant enterobacteriacea
- History of allergy or contraindication to the Ornidazole, Gentamycin, X-PREP or to any of the excipients of the drugs used.
- Cirrhosis of grade B and C (Child-Pugh classification)
- Myasthenia
- Allergy to one of the other treatments administered for the purpose of the trial (including betadine)
- Patient suffering from severe central neurologic diseases, fixed or progressive.
- Pregnant patients
- Refusal to participate or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.
Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.
Read the detailed description
Preoperative mechanical bowel preparation (MBP) has been proposed in an attempt to reduce the colonic fecal load and to limit the risk of surgical site contamination, thus theoretically limiting the risk of postoperative SSI. However, several randomized-controlled trials (RCT) and meta-analyses, have suggested the absence of benefit, in term of postoperative morbidity, of preoperative MBP before elective colon cancer surgery. A meta-analysis of RCT, comparing MBP to no-MBP before elective colon cancer surgery, even suggested that MBP could be associated with an increased SSI rate, as compared to no-MBP. These results led the latest French surgical guidelines of the Société Française de Chirurgie Digestive (SFCD) to recommend the absence of MBP before elective colon cancer surgery.
However, recent studies suggested that the adjunction of oral antibiotics during MBP could help efficiently reduce the risk of postoperative SSI. Indeed, a recent meta-analysis of RCT have suggested that patients preoperatively receiving both MBP and oral antibiotics were exposed to a significantly reduced risk of postoperative SSI, as compared to patients receiving only preoperative MBP. This result was confirmed in a recent RCT which compared preoperative MBP and oral antibiotics versus MBP alone in a heterogeneous population of patients who underwent laparoscopic colonic or rectal surgery. This latter study reported a 50% reduction of SSI rate in the "MBP and oral antibiotics" group, as compared to the "MBP alone" group. Finally, three recent large retrospective registry studies compared the outcomes of four different strategies of preoperative colonic preparation before colorectal surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No colonic preparation. However, to date, no RCT has compared the "No preparation" group, which is the gold standard according to the international and French guidelines, to the "MBP and oral antibiotics" group.
The present study is therefore the first double-blinded RCT to compare the SSI rate for 4 types of colonic preparation before elective laparoscopic colonic surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No preparation.
- Conditions
- Colon Cancer
- Being tested
- Sennosides colonic preparation, Oral Gentamycin, Oral Ornidazole, Oral placebo Gentamycin, Oral placebo Ornidazole
- Keywords
- Mechanical Bowel Preparation (MBP), Oral antibiotics, Colon cancer surgery, Surgical site infection
- 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.
Sennosides colonic preparationDrug
Mechanical bowel preparation :
Sennosides colonic preparation (X-PREP)
1 per day, on day -2 and day -1
Oral GentamycinDrug
Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials
Oral OrnidazoleDrug
Oral Ornidazole :
Ornidazole
1 g per day (2 tablet per day), on day -2 and day -1; In tablets
Oral placebo GentamycinDrug
Placebo for oral gentamycin :
Same presentation as oral gentamycin x4 per day on day -2 and day -1
Oral placebo OrnidazoleDrug
Placebo for oral Ornidazole :
Same presentation as oral ornidazole
1g per day (2 tablet per day) on day -2 and day -1
| Study group | Role | What they receive |
|---|---|---|
| 1) " MBP and oral antibiotics " group | Experimental | Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
* Sennosides colonic preparation (X-PREP) :
1 per day, on day -2 and day -1.
* Gentamycin :
80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
* Ornidazole :
1. g per day (2 tablet per day), on day -2 and day -1; In tablets. Receives: Drug: Sennosides colonic preparation; Drug: Oral Gentamycin; Drug: Oral Ornidazole |
| 2) " MBP alone " group | Placebo comparator | Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
* Sennosides colonic preparation (X-PREP) :
1 per day, on day -2 and day -1.
* Placebo for oral gentamycin:
Same presentation as oral gentamycin x4 per day on day -2 and day -1. - Placebo for oral ornidazole : Same presentation as oral ornidazole
1g per day (2 tablet per day) on day -2 and day -1. Receives: Drug: Sennosides colonic preparation; Drug: Oral placebo Gentamycin; Drug: Oral placebo Ornidazole |
| 3) " Oral antibiotics alone " group | Experimental | Oral Gentamycin Oral Ornidazole
* Gentamycin :
80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
* Ornidazole :
1. g per day (2 tablet per day), on day -2 and day -1; In tablets. Receives: Drug: Oral Gentamycin; Drug: Oral Ornidazole |
| 4) " No preparation " group | Placebo comparator | Oral placebo Gentamycin Oral placebo Ornidazole
- Placebo for oral gentamycin : Same presentation as oral gentamycin x4 per day on day -2 and day -1
- Placebo for oral ornidazole : Same presentation as oral ornidazole
1g per day (2 tablet per day) on day -2 and day -1 Receives: Drug: Oral placebo Gentamycin; Drug: Oral placebo Ornidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 30-day surgical site infection (SSI).
SSI will be defined and classified as superficial, deep and/or organ-space infection on the basis of validated and well-defined criteria developed by the Centers for Disease Control and Prevention (CDC), validated in French by the Comité technique des infections nosocomiales et des infections liées aux soins
Measured: 30 days
Secondary outcomes (10)
Overall postoperative morbidity
Including all postoperative complications occurring within 30 days after surgery, defined and classified according to the Clavien-Dindo classification.
Measured: 30 days
Severe postoperative morbidity
Including all complications graded 3 or more according to the Clavien-Dindo classification, and occurring within 30 days after surgery.
Measured: 30 days
Postoperative mortality
Including all deaths occurring within 30 days after surgery.
Measured: 30 days
Postoperative anastomotic leakage
Defined as the passing of any intra-colonic content (air, liquid, intestinal content, or radiological contrast) through an anastomosis or by an peri-anastomotic abscess, even in the absence of intra-colonic content leak through the anastomosis, observed in drainages, surgical incision, vagina, during a surgical procedure or on a radiological examination, occurring within 90 days after surgery.
Measured: 90 days
Postoperative length of hospital stay
Calculated from the day of surgery to the day of hospital discharge.
Measured: Day of hospital discharge
Unplanned hospitalization
Defined as any unplanned hospitalization between surgery and postoperative day 90.
Measured: 90 days
Tolerance of the colonic preparation
Evaluated using a dedicated tolerance of the colonic preparation questionnaire performed the evening before surgery.
Measured: The day before surgery
Clostridium difficile colitis occurrence
Defined as clinical symptoms of clostridium difficile colitis with at least 1 stool sample positive for Clostridium difficile toxin A/B as detected by enzyme-linked immunosorbent assay within 30 days after surgery.
Measured: 30 days
Rate of multi-resistant bacteria carriage
Defined as rate of multi-resistant bacteria carriage
Measured: The day before or the day of surgery
Date of adjuvant chemotherapy beginning
If indicated
Measured: During 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start8 Aug 2018
- Primary completion26 Aug 2021
- Study completion23 Mar 2022
Why it stopped: lack of inclusions
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475680
- Sponsor's protocol ID
- P161202J
- Acronym
- COLONPREP
- Status last verified
- May 2022
- First submitted
- 9 Mar 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)
- ClinicalTrials.gov ID
- NCT03475680
- Acronym / sponsor ID
- COLONPREP / P161202J
- Conditions
- Colon Cancer
- Keywords
- Mechanical Bowel Preparation (MBP), Oral antibiotics, Colon cancer surgery, Surgical site infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusions
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 23 Mar 2018 (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 aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.
Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.
Detailed description
Preoperative mechanical bowel preparation (MBP) has been proposed in an attempt to reduce the colonic fecal load and to limit the risk of surgical site contamination, thus theoretically limiting the risk of postoperative SSI. However, several randomized-controlled trials (RCT) and meta-analyses, have suggested the absence of benefit, in term of postoperative morbidity, of preoperative MBP before elective colon cancer surgery. A meta-analysis of RCT, comparing MBP to no-MBP before elective colon cancer surgery, even suggested that MBP could be associated with an increased SSI rate, as compared to no-MBP. These results led the latest French surgical guidelines of the Société Française de Chirurgie Digestive (SFCD) to recommend the absence of MBP before elective colon cancer surgery.
However, recent studies suggested that the adjunction of oral antibiotics during MBP could help efficiently reduce the risk of postoperative SSI. Indeed, a recent meta-analysis of RCT have suggested that patients preoperatively receiving both MBP and oral antibiotics were exposed to a significantly reduced risk of postoperative SSI, as compared to patients receiving only preoperative MBP. This result was confirmed in a recent RCT which compared preoperative MBP and oral antibiotics versus MBP alone in a heterogeneous population of patients who underwent laparoscopic colonic or rectal surgery. This latter study reported a 50% reduction of SSI rate in the "MBP and oral antibiotics" group, as compared to the "MBP alone" group. Finally, three recent large retrospective registry studies compared the outcomes of four different strategies of preoperative colonic preparation before colorectal surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No colonic preparation. However, to date, no RCT has compared the "No preparation" group, which is the gold standard according to the international and French guidelines, to the "MBP and oral antibiotics" group.
The present study is therefore the first double-blinded RCT to compare the SSI rate for 4 types of colonic preparation before elective laparoscopic colonic surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No preparation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1) " MBP and oral antibiotics " group | Experimental | Drug: Sennosides colonic preparation, Drug: Oral Gentamycin, Drug: Oral OrnidazoleSennosides colonic preparation Oral Gentamycin Oral Ornidazole * Sennosides colonic preparation (X-PREP) : 1 per day, on day -2 and day -1. * Gentamycin : 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials. * Ornidazole : 1. g per day (2 tablet per day), on day -2 and day -1; In tablets. |
| 2) " MBP alone " group | Placebo comparator | Drug: Sennosides colonic preparation, Drug: Oral placebo Gentamycin, Drug: Oral placebo OrnidazoleSennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole * Sennosides colonic preparation (X-PREP) : 1 per day, on day -2 and day -1. * Placebo for oral gentamycin: Same presentation as oral gentamycin x4 per day on day -2 and day -1. - Placebo for oral ornidazole : Same presentation as oral ornidazole 1g per day (2 tablet per day) on day -2 and day -1. |
| 3) " Oral antibiotics alone " group | Experimental | Drug: Oral Gentamycin, Drug: Oral OrnidazoleOral Gentamycin Oral Ornidazole * Gentamycin : 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials. * Ornidazole : 1. g per day (2 tablet per day), on day -2 and day -1; In tablets. |
| 4) " No preparation " group | Placebo comparator | Drug: Oral placebo Gentamycin, Drug: Oral placebo OrnidazoleOral placebo Gentamycin Oral placebo Ornidazole - Placebo for oral gentamycin : Same presentation as oral gentamycin x4 per day on day -2 and day -1 - Placebo for oral ornidazole : Same presentation as oral ornidazole 1g per day (2 tablet per day) on day -2 and day -1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 or more
- Scheduled to undergo elective restorative laparoscopic segmental colectomy for colon cancer
- With Signed consent
- And affiliated to the French social security system
Key exclusion criteria (16 listed)
- Emergent surgery
- Scheduled total or subtotal colectomy (defined as a colectomy extended from the right colon to a least the left colonic angle)
- Scheduled transverse colectomy
- Scheduled associated proctectomy
- Scheduled associated concomitant resection of another organ (liver, etc.), except the abdominal wall
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 |
|---|---|---|
| Sennosides colonic preparationMechanical bowel preparation : Sennosides colonic preparation (X-PREP) 1 per day, on day -2 and day -1 | Drug | 1) " MBP and oral antibiotics " group, 2) " MBP alone " group |
| Oral GentamycinGentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials | Drug | 1) " MBP and oral antibiotics " group, 3) " Oral antibiotics alone " group |
| Oral OrnidazoleOral Ornidazole : Ornidazole 1 g per day (2 tablet per day), on day -2 and day -1; In tablets | Drug | 1) " MBP and oral antibiotics " group, 3) " Oral antibiotics alone " group |
| Oral placebo GentamycinPlacebo for oral gentamycin : Same presentation as oral gentamycin x4 per day on day -2 and day -1 | Drug | 2) " MBP alone " group, 4) " No preparation " group |
| Oral placebo OrnidazolePlacebo for oral Ornidazole : Same presentation as oral ornidazole 1g per day (2 tablet per day) on day -2 and day -1 | Drug | 2) " MBP alone " group, 4) " No preparation " group |
Primary outcome
Postoperative 30-day surgical site infection (SSI).
Time frame: 30 days
SSI will be defined and classified as superficial, deep and/or organ-space infection on the basis of validated and well-defined criteria developed by the Centers for Disease Control and Prevention (CDC), validated in French by the Comité technique des infections nosocomiales et des infections liées aux soins
10 secondary outcomes
Overall postoperative morbidity
Time frame: 30 days
Severe postoperative morbidity
Time frame: 30 days
Postoperative mortality
Time frame: 30 days
Postoperative anastomotic leakage
Time frame: 90 days
Postoperative length of hospital stay
Time frame: Day of hospital discharge
Unplanned hospitalization
Time frame: 90 days
Tolerance of the colonic preparation
Time frame: The day before surgery
Clostridium difficile colitis occurrence
Time frame: 30 days
Rate of multi-resistant bacteria carriage
Time frame: The day before or the day of surgery
Date of adjuvant chemotherapy beginning
Time frame: During 90 days
Results and safety
The study was stopped early (reason given: lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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 Phase 3 study testing Sennosides colonic preparation, Oral Gentamycin and Oral Ornidazole in people with Colon Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 17 May 2022. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of inclusions). Results are not available in the source record.
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?
Postoperative 30-day surgical site infection (SSI). (time frame: 30 days). 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 17 May 2022.