Rectal Cancer SurgeryPhase 3PREPACOL2NCT03491540
Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery
A Phase 3 study testing Sennosides colonic preparation, Oral Gentamycin and Oral Ornidazole in people with Rectal Cancer Surgery, 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 rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Surgery
- 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
- 414 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2018to 12 Dec 2023
- 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 cancer of the rectal (<15 cm from the anal margin) with sphincter preservation
- With Signed consent
- And affiliated to the French social security system
Who cannot join
- Emergent surgery
- Scheduled total colo-proctectomy
- Scheduled abdominoperineal restion with definitive colostomy
- Scheduled associated concomitant resection of another organ (liver, etc.)
- Active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before surgery)
- Associated inflammatory bowel disease
Show all 14Show fewer
- 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.
France1 site
Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis
Paris, Île-de-France Region, 75010
About this study
Official title: Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone
Read the detailed description
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone.
This study's hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone 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 surgical site infection (SSI). However, the benefit of such MBP before colorectal surgery is related to type of procedure performed. Indeed, several randomized controlled trials (RCT) and meta-analyses have demonstrated the absence of benefit of MBP before colon cancer surgery, whereas a recent RCT suggested that MBP before rectal cancer surgery was associated to a significant reduction of postoperative SSI, as compare to the absence of preoperative MBP.
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. However, to date, no RCT compared the outcomes of an MBP with oral antibiotics to MBP without oral antibiotics in a homogeneous cohort of patients undergoing rectal cancer surgery.
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone.
- Conditions
- Rectal Cancer Surgery
- Being tested
- Sennosides colonic preparation, Oral Gentamycin, Oral Ornidazole, Oral Placebo Gentamycin, Oral Placebo Ornidazole
- Keywords
- Mechanical Bowel Preparation (MBP), Oral antibiotics, Rectal cancer surgery, Surgical site infection
- Medical subject headings
- 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
Oral gentamycin:
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 tablets 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 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 Receives: Drug: Sennosides colonic preparation; 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 (11)
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: Up to 90 days
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 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: 90 days
Temporary stoma closure rate
Define as temporary stoma closure
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start3 Sep 2018
- Primary completion23 Oct 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer SurgeryStudies 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
- 414 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
- NCT03491540
- Sponsor's protocol ID
- P160938J
- Acronym
- PREPACOL2
- Status last verified
- Jan 2024
- First submitted
- 9 Mar 2018
- Last updated
- 5 Jan 2024
- 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.
Publications
Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
PubMed 36748942
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
- ClinicalTrials.gov ID
- NCT03491540
- Acronym / sponsor ID
- PREPACOL2 / P160938J
- Conditions
- Rectal Cancer Surgery
- Keywords
- Mechanical Bowel Preparation (MBP), Oral antibiotics, Rectal cancer surgery, Surgical site infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 9 Apr 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 rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone
Detailed description
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone.
This study's hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone 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 surgical site infection (SSI). However, the benefit of such MBP before colorectal surgery is related to type of procedure performed. Indeed, several randomized controlled trials (RCT) and meta-analyses have demonstrated the absence of benefit of MBP before colon cancer surgery, whereas a recent RCT suggested that MBP before rectal cancer surgery was associated to a significant reduction of postoperative SSI, as compare to the absence of preoperative MBP.
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. However, to date, no RCT compared the outcomes of an MBP with oral antibiotics to MBP without oral antibiotics in a homogeneous cohort of patients undergoing rectal cancer surgery.
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| 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 |
| 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 |
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 cancer of the rectal (<15 cm from the anal margin) with sphincter preservation
- With Signed consent
- And affiliated to the French social security system
Key exclusion criteria (14 listed)
- Emergent surgery
- Scheduled total colo-proctectomy
- Scheduled abdominoperineal restion with definitive colostomy
- Scheduled associated concomitant resection of another organ (liver, etc.)
- Active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before 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 |
|---|---|---|
| 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 GentamycinOral gentamycin: Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials | Drug | 1) " MBP and oral antibiotics " 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 |
| 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 |
| Oral Placebo OrnidazolePlacebo for oral ornidazole : Same presentation as oral ornidazole 1g per day (2 tablets per day) on day -2 and day -1 | Drug | 2) " MBP alone " 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.
11 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: Up to 90 days
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: 90 days
Temporary stoma closure rate
Time frame: 90 days
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 5 Jan 2024.
- Derived from this study: PubMed 36748942Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
- 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 Rectal Cancer Surgery, 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 14 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 5 Jan 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 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 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?
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?
On the ClinicalTrials.gov record for NCT03491540, which also lists 1 linked publication.
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 5 Jan 2024.