TDRAIN: A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03974672

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Jan 1, 2014

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
T drain Patients treated with a T drain approach	Procedure: Re-laparotomy
Stoma Patients treated with a stoma	Procedure: Re-laparotomy

Arm

Intervention/Treatment

T drain

Patients treated with a T drain approach

Procedure: Re-laparotomy

Stoma

Patients treated with a stoma

Procedure: Re-laparotomy

Outcome Measures

Primary Outcome Measures

Measuring severity of complications with the Dindo Clavien complications scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

under 18 years of age
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar Saba		Israel

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator: Yaron Rudnicki, MD, Meir Medical Center Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

yaron rudnicki, Principal Investigator, Meir Medical Center

ClinicalTrials.gov Identifier:

NCT03974672

Other Study ID Numbers:

MMC-0340-16-CTIL

First Posted:

Jun 5, 2019

Last Update Posted:

Jun 5, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diverticulitis

Anastomotic Leak

Study Results

No Results Posted as of Jun 5, 2019