Trial Outcomes & Findings for Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy (NCT NCT02343302)
NCT ID: NCT02343302
Last Updated: 2021-12-21
Results Overview
The primary endpoint of the study is the developement of post-operative pancreatic fistula, as defined by the International Study Group of Pancreatic Surgery.
TERMINATED
NA
2 participants
90 days
2021-12-21
Participant Flow
Participant milestones
| Measure |
Soft Pancreatic Gland
This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.
Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"
Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"
|
Hard Pancreatic Gland
This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.
Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"
Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"
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|---|---|---|
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Overall Study
STARTED
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1
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1
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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1
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1
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Reasons for withdrawal
| Measure |
Soft Pancreatic Gland
This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.
Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"
Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"
|
Hard Pancreatic Gland
This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.
Jackson-Pratt Drain: A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"
Non-suctioning drainage: A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"
|
|---|---|---|
|
Overall Study
Physician Decision
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1
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1
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Baseline Characteristics
Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 90 daysPopulation: Work on this project was discontinued due to poor recruitmemt. Data was not collected for this outcome measure.
The primary endpoint of the study is the developement of post-operative pancreatic fistula, as defined by the International Study Group of Pancreatic Surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Work on this project was discontinued due to poor recruitmemt. Data was not collected for this outcome measure.
All morbidity, including length of hospital stay, need for enteral/parenteral nutrition, need for radiologic/surgical intervention, septic complications, and peri-operative mortality.
Outcome measures
Outcome data not reported
Adverse Events
Soft Pancreatic Gland
Hard Pancreatic Gland
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place