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Currently it is unclear whether postoperative chyle leak (CL) after pancreatic surgery requires treatment. Thus, the present study aims to compare dietary treatment of CL with drain removal despite of persistent CL.
With an incidence of up to 11%, postoperative chyle leak (CL) is a frequent phenomenon after pancreatic surgery, where extensive lymph node dissections are indispensable. Postoperative CL is frequently treated with either medium-chain triglyceride diet (MCT-diet) or total parenteral nutrition (TPN). Ignoring CL and removing the surgical drains irrespective of CL may also be discussed. While dietary restrictions are known to hinder postoperative convalescence and prolong the length of stay at the hospital, recent retrospective data show that leaving CL untreated is not associated with an increased morbidity rate. More precisely, removing the surgical drains irrespective of CL does not result in an increased incidence of CT-guided drainages. However, prospective data on CL after pancreatic surgery do not exist in the literature. Accordingly, the present trial aims to compare treatment of CL with dietary restrictions to removing the surgical drains irrespective of CL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ignoring CL (group A) | Experimental | Standard care irrespective of CL. |
|
| Dietary treatment (group B) | Active Comparator | Dietary treatment with medium-chain triglyceride diet (MCT-diet) until resolution of CL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care irrespective of CL | Other | Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity | Complications ≥ Clavien-Dindo3 grade IIIa | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay at the hospital | The time spent at the hospital will be recorded | 90 days postoperatively |
| Time until drain removal | The time until drain removal will be recorded |
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Inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan D'Haese, M.D. | Contact | +49894400712210 | jan.dhaese@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Jan D'Haese, M.D. | Ludwig-Maximilians - University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig-Maximilians-University | Recruiting | Munich | Germany |
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| ID | Term |
|---|---|
| D002915 | Chylous Ascites |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| Dietary treatment (MCT-diet) | Other | Dietary treatment with MCT-diet until resolution of CL. |
|
| 30 days postoperatively |
| Readmission to the hospital | Patients will be called and asked for any readmission to a hospital (yes /no) | 90 days postoperatively |
| Weight change | Weight (Day before surgery) - Weight (10 days postoperatively) | The day before surgery until postoperative day 10 |
| Body mass index (BMI) change | BMI (day before surgery) - BMI (10 days postoperatively) | The day before surgery until postoperative day 10 |
| International normalized ration (INR) change | INR (Day before surgery) - INR (10 days postoperatively) | The day before surgery until postoperative day 10 |
| Albumin change | Albumin level (Day before surgery) - Albumin level (10 days postoperatively) | The day before surgery until postoperative day 10 |
| Postoperative cortisol level | Cortisol levels will be compared between group A and B | 8 days postoperatively |
| Freiburg index of patient satisfaction | Patient satisfaction will be measured using a standardized questionnaire | Postoperative day 10 |