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Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359498
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Clinical Research Consultants, Inc.
Information provided by (Responsible Party):
Safeheal

Brief Summary:
This study is being conducted to evaluate the incidence and type of surgical complications occurring in patients who have a defunctioning stoma after LARfor rectal cancer. The data from this retrospective study will be analyzed by the study Sponsor to aid in designing a prospective clinical trial for a new technology that offers a treatment alternative to standard of care defunctioning stoma in patients undergoing LAR for rectal cancer.

Condition or disease
Rectal Cancer

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection for Rectal Cancer
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Group/Cohort
LAR for rectal cancer
Retrospective chart review for surgical complications related to the LAR surgery, the stoma (diverting loop ileostomy) creation and the stoma reversal procedure after LAR for rectal cancer.



Primary Outcome Measures :
  1. Surgical complications [ Time Frame: 12 Months ]
    Characterize the type and incidence of surgical complications related to the LAR, the stoma creation and the stoma reversal after LAR for rectal cancer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent LAR for rectal cancer and are 12 months or longer postoperative from the LAR surgery will be reviewed for eligibility.
Criteria

Inclusion Criteria:

  1. Adults, 18 years of age or older at the time the LAR surgery was performed.
  2. Having an open or minimally invasive colorectal resection with diverting loop ileostomy surgical procedure performed between January 15, 2015 and January 15, 2019 for treatment of a known or suspected malignant condition.
  3. Availability of medical records for a postoperative visit occurring 12 months (± 3 months) after the LAR surgery.

Exclusion Criteria:

  1. Planned surgical procedure is a Hartmann's procedure (surgical resection of the rectosigmoid colon with closure of the anorectal stump and formation of an end colostomy).
  2. Having a documented medical history of inflammatory bowel disease prior to the LAR surgery.
  3. Having a concomitant major surgical procedure performed in combination with the LAR surgery (e.g., colorectal resection with hepatectomy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359498


Contacts
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Contact: Jodi Pitcher 513-962-8200 jlfant@crc-regulatory.om

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Carlos Chavez, MD    714-456-5396    chavezc@hs.uci.edu   
Principal Investigator: Alessio Pigazzi, MD         
Keck School of Medicine of USC Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Sang Won Lee, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Gayane Ovsepyan    310-289-9224    Gayane.Ovsepyan@cshs.org   
Principal Investigator: Karen Zaghiyan, MD         
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Khattiya Chharath    813-844-4686    kchharath@usf.edu   
Principal Investigator: Jorge Marcet, MD         
United States, Massachusetts
UMASS Memorial Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Sharon Balcom    508-334-4918    Sharon.Balcom@umassmed.edu   
Principal Investigator: Justin Maykel, MD         
United States, New York
Northwell Health, Inc. Recruiting
New Hyde Park, New York, United States, 11042
Contact: Sally Kaplan    516-562-4578    skaplan2@northwell.edu   
Principal Investigator: Joseph Marz, MD         
Icahn School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Antoinette Bonaccorso    212-241-3547    Antoinette.Bonaccorso@mountsinai.org   
Principal Investigator: Patricia Sylla, MD         
Canada, Ontario
Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6C 2R5
Contact: Chadia ElKhatib    519-663-3985    Chadia.ElKhatib@lhsc.on.ca   
Principal Investigator: Nawar Alkhamesi, MD, PhD         
Sponsors and Collaborators
Safeheal
Clinical Research Consultants, Inc.
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Responsible Party: Safeheal
ClinicalTrials.gov Identifier: NCT04359498    
Other Study ID Numbers: SH-001
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Safeheal:
Low Anterior Resection
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases