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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Diverticulitis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• under 18 years of age
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Yaron Rudnicki, MD, Meir Medical Center Israel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 26, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Anastomotic Leak; Diverticulitis
• Other Study ID Numbers: MMC-0340-16-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All none identifying patients information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No