Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive IleostomyPhase 3NCT03462563
Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™
A Phase 3 study testing INTERCEED™ in people with Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy, run by Ethicon, Inc. at 12 sites in China.
Trial summary
This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy
- What is being tested?
- INTERCEED™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 12 sitesChina
- Study dates
- 16 Apr 2018to 24 Feb 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects elder than 18 years of age who require laparoscopic colorectal resection with the formation of a temporary diverting loop ileostomy and a planned closure of diverting ileostomy within 3 to 7 months The subjects should be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent prior to any study-related procedures The target incision length less than 8cm allowing the INTERCEED (product length 10.2cm) to overlap at least 1cm beyond each pole of the incision The subject is believed to have life expectancy more than 12 months after Phase 1 operation, based on investigators assessment.
- Exclusion Criteria Female patients who are pregnant or lactating at the time of screening Patient with a history of mechanical bowel obstruction but except the mechanical bowel obstruction caused by the colorectal cancer treated in the Phase I operation. Subjects with history of mid and lower abdominal region or pelvic surgery Patients for whom it is known that loop ileostomy closure within 3 to 9 months is not feasible Patients with a history of active intra-abdominal infection such as peritonitis or abdominal abscess Patients with a history of intestinal fistulae Patients with a history of endometriosis Intended use of intraoperative lavage/irrigation with any anti-adhesion solutions other than saline or an adhesion barrier other than INTERCEED Use of immune system suppressants deemed by the investigator to interfere with wound healing Impaired immune system function or coagulation disorders deemed by the surgeon to interfere with wound healing.
- Bevacizumab use within 30 days prior to surgery Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures Patients with evidence of distant metastasis of the primary colorectal cancer Patients who underwent abdominal radiotherapy before Phase 1 operation Adhesions (Grade 2-3 adhesion) and/or gross contamination (caused by tumor perforation) present in the abdominal cavity at the Phase 1 operation The rectal carcinoma radical resection (R0 resection) preventive ileostomy are not performed in Phase 1 operation pected resection of other organs (bladder, uterus) during Phase 1 operation Use of topical haemostatic products, local motherapeutic products or other drugs and/or medical device in abdominal/pelvic cavity which may impact the study primary endpoint judged by the investigator Patient is participating in other investigational drug or device study within 30 days or 5 half-lives of an investigational drug A known history of severe multiple drug allergies or known allergy to cellulose or cellulose derived products Any medications, treatments and/or implanted devices (except INTERCEED) that on investigator's opinion may be adhesiogenic or may potentially affect the observation of postoperative adhesions Any physical or psychological conditions that at discretion of investigators may impair study participation A medical condition or other serious conditions that will interfere with compliance and/or ability to complete this study protocol; or Any other situation or reason that at discretion of investigators is unsuitable for study participation
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Chinese PLA General Hospital
Beijing, 100039
Friendship Hospital
Beijing, 100050
The First Hospital of Jilin University
Changchun, Jilin, 130021
Xiangya Hospital Central South University
Changsha, Hunan, 410008
The 2nd affiliated Hospital of Zhongnan University
Changsha, Hunan, 410011
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Shanghai Jiaotong University School of Medcine, Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Changhai Hospital
Shanghai, 200433
The affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
First affiliated hospital of zhengzhou university
Zhengzhou, Henan, 450052
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of GYNECARE INTERCEED™ Absorbable Adhesion Barrier in Preventing the Abdominal Incision Adhesions
This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation).
During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen). The subjects will return 3-9 months after the phase 1 operation (colorectal resection with temporary ileostomy) for phase 2 operation, to have their diverting ostomy taken down (ileostomy reversal). During the phase 2 operation (ileostomy reversal), the incidence, extent and severity of adhesions will be evaluated through the laparoscope.
Read the detailed description
This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation).
During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen).
The subjects will return 3-9 months after the phase 1 operation (colorectal resection with temporary ileostomy) for phase 2 operation, to have their diverting ostomy taken down (ileostomy reversal).
During the phase 2 operation (ileostomy reversal), the incidence, extent and severity of adhesions will be evaluated through the laparoscope.
An ad-hoc interim analysis is proposed based on feedback received from the investigators who observed very low rate of adhesions at the second procedure for ostomy reversal. The ad-hoc interim analysis is planned to be performed while at least 61% of the total number of participants with evaluable primary endpoints are available. If the conditional power (CP) is ≤ 60%, the observed adhesion rate difference magnitude is much less than the assumed difference magnitude of 0.25, therefore, the study will be terminated due to low adhesion rate and small effect size between INTERCEED and control arms. Otherwise, the study will continue until the study completion as planned.
- Being tested
- INTERCEED™, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERCEED™Device
when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen)
PlaceboDevice
During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo).
| Study group | Role | What they receive |
|---|---|---|
| INTERCEED™ | Experimental | patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen). Receives: Device: INTERCEED™ |
| standard of care treatment | Placebo comparator | During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Free of Adhesions at the Target Incision Site
Percentage of participants free of adhesions at the target incision site in each study group based on evaluation through laparoscopy at ileostomy reversal were reported.
Measured: 3 to 9 months after phase 1 operation
Secondary outcomes (5)
Number of Participants With Extent of Adhesions at Target Incision Site in Phase 2 Operation
Number of participants with extent of adhesions at target incision site in Phase 2 operation were reported. The extent of adhesions (percentage of the area covered by adhesion) was evaluated based on Grade 1: mild, covering up to 25 percent (%) of the total area and length; Grade 2: moderate, covering 26%-50% of the total area and length; and Grade 3: severe, covering over 50% of the total area and length.
Measured: 3 to 6 months after phase 1 operation
Number of Participants With Severity of Adhesions at Target Incision Site in Phase 2 Operation
Number of participants with severity of adhesions at target incision site in Phase 2 operation were reported. The severity of adhesions was evaluated based on Grade 1: filmy thickness, avascular; Grade 2: moderate thickness, limited vascularity and Grade 3: dense thickness, vascularized.
Measured: 3 to 9 months after phase 1 operation
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation
Number of participants with extent of adhesions at four abdominal quadrants in Phase 2 operation were reported. The abdominal cavity was divided into four abdominal quadrants as: Right upper abdominal quadrant, Left upper abdominal quadrant, Right lower abdominal quadrant and Left lower abdominal quadrant and the extent of adhesions (percentage of the area covered by adhesion) was evaluated based on Grade 1: mild, covering up to 25% of the total area and length; Grade 2: moderate, covering 26%-50% of the total area and length; and Grade 3: severe, covering over 50% of the total area and length. One participant may have multiple sites of adhesion.
Measured: 3 to 9 months after phase 1 operation
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation
Number of participants with severity of adhesions at four abdominal quadrants in Phase 2 operation were reported. The abdominal cavity was divided into four abdominal quadrants as: Right upper abdominal quadrant, Left upper abdominal quadrant, Right lower abdominal quadrant and Left lower abdominal quadrant and the severity of adhesions was evaluated based on Grade 1: filmy thickness, avascular; Grade 2: moderate thickness, limited vascularity and Grade 3: dense thickness, vascularized. One participant may have multiple sites of adhesion.
Measured: 3 to 6 months after phase 1 operation
Number of Participants With Mechanical Ileus
Number of participants with mechanical ileus were reported. Incidence of mechanical ileus was defined as the mechanical ileus judged by investigators, which occurred 1 week after Phase 1 operation. Incidence of mechanical ileus was reported based on three categories: Post-Phase 1 operation through 7 days after Phase 1 operation (less than or equal to [<=] 7 days) (for participants underwent Phase 1 operation), 7 days after Phase 1 operation through pre-Phase 2 operation (for participants underwent Phase 1 operation) and Post-Phase 2 operation (for participants underwent Phase 2 operation).
Measured: Up to 9 months after phase 1 operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start16 Apr 2018
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Why it stopped: The study was terminated because the pre-specified study stopping criterion has been met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive IleostomyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462563
- Sponsor's protocol ID
- ESC-201701
- Status last verified
- Aug 2022
- First submitted
- 6 Mar 2018
- Last updated
- 10 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of GYNECARE INTERCEED™ Absorbable Adhesion Barrier in Preventing the Abdominal Incision Adhesions
- ClinicalTrials.gov ID
- NCT03462563
- Acronym / sponsor ID
- ESC-201701
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because the pre-specified study stopping criterion has been met.
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Posted 13 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation).
During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen). The subjects will return 3-9 months after the phase 1 operation (colorectal resection with temporary ileostomy) for phase 2 operation, to have their diverting ostomy taken down (ileostomy reversal). During the phase 2 operation (ileostomy reversal), the incidence, extent and severity of adhesions will be evaluated through the laparoscope.
Detailed description
This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation).
During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen).
The subjects will return 3-9 months after the phase 1 operation (colorectal resection with temporary ileostomy) for phase 2 operation, to have their diverting ostomy taken down (ileostomy reversal).
During the phase 2 operation (ileostomy reversal), the incidence, extent and severity of adhesions will be evaluated through the laparoscope.
An ad-hoc interim analysis is proposed based on feedback received from the investigators who observed very low rate of adhesions at the second procedure for ostomy reversal. The ad-hoc interim analysis is planned to be performed while at least 61% of the total number of participants with evaluable primary endpoints are available. If the conditional power (CP) is ≤ 60%, the observed adhesion rate difference magnitude is much less than the assumed difference magnitude of 0.25, therefore, the study will be terminated due to low adhesion rate and small effect size between INTERCEED and control arms. Otherwise, the study will continue until the study completion as planned.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERCEED™ | Experimental | Device: INTERCEED™patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen). |
| standard of care treatment | Placebo comparator | Device: PlaceboDuring the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects elder than 18 years of age who require laparoscopic colorectal resection with the formation of a temporary diverting loop ileostomy and a planned closure of diverting ileostomy within 3 to 7 months The subjects should be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent prior to any study-related procedures The target incision length less than 8cm allowing the INTERCEED (product length 10.2cm) to overlap at least 1cm beyond each pole of the incision The subject is believed to have life expectancy more than 12 months after Phase 1 operation, based on investigators assessment.
- Exclusion Criteria Female patients who are pregnant or lactating at the time of screening Patient with a history of mechanical bowel obstruction but except the mechanical bowel obstruction caused by the colorectal cancer treated in the Phase I operation. Subjects with history of mid and lower abdominal region or pelvic surgery Patients for whom it is known that loop ileostomy closure within 3 to 9 months is not feasible Patients with a history of active intra-abdominal infection such as peritonitis or abdominal abscess Patients with a history of intestinal fistulae Patients with a history of endometriosis Intended use of intraoperative lavage/irrigation with any anti-adhesion solutions other than saline or an adhesion barrier other than INTERCEED Use of immune system suppressants deemed by the investigator to interfere with wound healing Impaired immune system function or coagulation disorders deemed by the surgeon to interfere with wound healing.
- Bevacizumab use within 30 days prior to surgery Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures Patients with evidence of distant metastasis of the primary colorectal cancer Patients who underwent abdominal radiotherapy before Phase 1 operation Adhesions (Grade 2-3 adhesion) and/or gross contamination (caused by tumor perforation) present in the abdominal cavity at the Phase 1 operation The rectal carcinoma radical resection (R0 resection) preventive ileostomy are not performed in Phase 1 operation pected resection of other organs (bladder, uterus) during Phase 1 operation Use of topical haemostatic products, local motherapeutic products or other drugs and/or medical device in abdominal/pelvic cavity which may impact the study primary endpoint judged by the investigator Patient is participating in other investigational drug or device study within 30 days or 5 half-lives of an investigational drug A known history of severe multiple drug allergies or known allergy to cellulose or cellulose derived products Any medications, treatments and/or implanted devices (except INTERCEED) that on investigator's opinion may be adhesiogenic or may potentially affect the observation of postoperative adhesions Any physical or psychological conditions that at discretion of investigators may impair study participation A medical condition or other serious conditions that will interfere with compliance and/or ability to complete this study protocol; or Any other situation or reason that at discretion of investigators is unsuitable for study participation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| INTERCEED™when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen) | Device | INTERCEED™ |
| PlaceboDuring the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). | Device | standard of care treatment |
Primary outcome
Percentage of Participants Free of Adhesions at the Target Incision Site
Time frame: 3 to 9 months after phase 1 operation
Percentage of participants free of adhesions at the target incision site in each study group based on evaluation through laparoscopy at ileostomy reversal were reported.
5 secondary outcomes
Number of Participants With Extent of Adhesions at Target Incision Site in Phase 2 Operation
Time frame: 3 to 6 months after phase 1 operation
Number of Participants With Severity of Adhesions at Target Incision Site in Phase 2 Operation
Time frame: 3 to 9 months after phase 1 operation
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation
Time frame: 3 to 9 months after phase 1 operation
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation
Time frame: 3 to 6 months after phase 1 operation
Number of Participants With Mechanical Ileus
Time frame: Up to 9 months after phase 1 operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INTERCEED™ in people with Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy, run by Ethicon, Inc. at 12 sites 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 3 inclusion and 0 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 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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. 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?
Yes. Results are posted in the registry (first posted 13 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Free of Adhesions at the Target Incision Site (time frame: 3 to 9 months after phase 1 operation). 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 10 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.