Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™
Condition: Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy
Intervention: INTERCEED™; Placebo
Intervention description: 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); 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).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

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).

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        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