A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery

Colorectal Cancer Clinical Trial

— TDRAIN  

Official title:

A Retrospective Study Using a T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974672
• Other study ID #: MMC-0340-16-CTIL
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• under 18 years of age

• Pregnancy

Related Conditions & MeSH terms

• Anastomotic Leak
• Colorectal Cancer
• Colorectal Neoplasms
• Diverticulitis

Intervention

Procedure:
• Re-laparotomy

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring severity of complications with the Dindo Clavien complications scale	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.	30 day post operation