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出境医 / 临床实验 / A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery (TDRAIN)
A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery (TDRAIN)
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 |
|---|---|
| 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 : | January 1, 2014 |
| Actual Primary Completion Date : | December 31, 2018 |
| Actual Study Completion Date : | December 31, 2018 |
Arms 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 |
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Locations
| Israel | |
| Meir Medical Center | |
| Kfar Saba, Israel | |
Sponsors and Collaborators
Meir Medical Center
Investigators
| Principal Investigator: | Yaron Rudnicki, MD | Meir Medical Center Israel |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 26, 2019 | ||||
| First Posted Date | June 5, 2019 | ||||
| Last Update Posted Date | June 5, 2019 | ||||
| Actual Study Start Date | January 1, 2014 | ||||
| Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery | ||||
| Official Title | A Retrospective Study Using a T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery | ||||
| 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. | ||||
| 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis | ||||
| Condition |
|
||||
| Intervention | Procedure: Re-laparotomy | ||||
| Study Groups/Cohorts |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
50 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2018 | ||||
| Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Israel | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03974672 | ||||
| Other Study ID Numbers | MMC-0340-16-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
|
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| Responsible Party | yaron rudnicki, Meir Medical Center | ||||
| Study Sponsor | Meir Medical Center | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Meir Medical Center | ||||
| Verification Date | June 2019 | ||||
