Status:
TERMINATED
Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™
Lead Sponsor:
Ethicon, Inc.
Conditions:
Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief 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 (Ph...
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 (Ph...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2021
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03462563
Start Date
April 16 2018
End Date
February 24 2021
Last Update
August 10 2022
Active Locations (12)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
First affiliated hospital of zhengzhou university
Zhengzhou, Henan, China, 450052
3
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
4
The 2nd affiliated Hospital of Zhongnan University
Changsha, Hunan, China, 410011