N/A
Completed N=399
Pancreas Resection With and Without Drains
Source: ClinicalTrials.gov NCT01441492 ↗Enrolled (actual)
399
Serious AEs
0.6%
Results posted
Aug 2020
Primary outcomePrimary: 60-day ≥ Grade II Complication Rate — 72; 76 Participants — p=0.804
Summary
This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 60-day ≥ Grade II Complication Rate |
72; 76 | 0.804 |
| SECONDARY 60-day ≥ Grade III Complication Rate |
44; 51 | — |
| SECONDARY Serious Adverse Event (SAE) Rate |
2; 0 | — |
| SECONDARY Median Complication Severity Grade |
1; 1; 4; 3 | — |
| SECONDARY 60-day Frequency of Complications |
1; 1 | — |
| SECONDARY 90-day Mortality Rate |
2; 0 | — |
| SECONDARY Rate of Specific Complications |
20; 88; 38; 15; 1; 1 | — |
| SECONDARY Length of Stay for the Index Admission |
5; 5 | — |
| SECONDARY Crude Cost |
— | — |
| SECONDARY Composite Quality of Life Scores |
21; 21; 21; 21; 20; 20 | — |
Eligibility Criteria
Inclusion Criteria
- The subject has a surgical indication for distal pancreatectomy.
- In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy.
- At least 18 years of age.
- The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group.
- The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
Exclusion Criteria
- The subject does not have a surgical indication for distal pancreatectomy.
- In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy.
- Less than 18 years of age.
- The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group.
- The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
Data sourced from ClinicalTrials.gov (NCT01441492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.