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A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery (TDRAIN)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03974672
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
yaron rudnicki, Meir Medical Center

Brief Summary:
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The study's aim is to retrospectively assess the safety and benefits of this approach.

Condition or disease Intervention/treatment
Colorectal Cancer Diverticulitis Procedure: Re-laparotomy

Detailed Description:
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The T drain approach is inserting a latex t tube drain into the leak site of the anastomosed bowel and diverting the fecal matter. The study's aim is to retrospectively assess the safety and benefits of this approach.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study Using a T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
T drain
Patients treated with a T drain approach
Procedure: Re-laparotomy
Stoma
Patients treated with a stoma
Procedure: Re-laparotomy



Primary Outcome Measures :
  1. Measuring severity of complications with the Dindo Clavien complications scale [ Time Frame: 30 day post operation ]
    By using the Dindo Clavien complications scale assessment of recuperation and complications rate and severity following re-laparotomy and assessing if another surgery was avoided.



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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:   Non-Probability Sample
Study Population
Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis
Criteria

Inclusion Criteria:

  • Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis

Exclusion Criteria:

  • under 18 years of age
  • Pregnancy

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): NCT03974672


Locations
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Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Yaron Rudnicki, MD Meir Medical Center Israel

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Responsible Party: yaron rudnicki, Principal Investigator, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03974672     History of Changes
Other Study ID Numbers: MMC-0340-16-CTIL
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All none identifying patients information

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diverticulitis
Colorectal Neoplasms
Anastomotic Leak
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Postoperative Complications
Pathologic Processes