NCT03974672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

5 years

First QC Date

May 26, 2019

Last Update Submit

June 4, 2019

Conditions

Colorectal CancerDiverticulitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

T drain

Patients treated with a T drain approach

Procedure: Re-laparotomy

Stoma

Patients treated with a stoma

Procedure: Re-laparotomy

Interventions

Re-laparotomyPROCEDURE
StomaT drain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • under 18 years of age
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Colorectal NeoplasmsDiverticulitis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDiverticular DiseasesGastroenteritis

Study Officials

  • Yaron Rudnicki, MD

    Meir Medical Center Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2019

First Posted

June 5, 2019

Study Start

January 1, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

IL(1)