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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL.
Dietary treatment with MCT-diet until resolution of CL.
Ludwig-Maximilians-University
Munich, Germany
RECRUITINGPostoperative morbidity
Complications ≥ Clavien-Dindo3 grade IIIa
Time frame: 30 days postoperatively
Length of stay at the hospital
The time spent at the hospital will be recorded
Time frame: 90 days postoperatively
Time until drain removal
The time until drain removal will be recorded
Time frame: 30 days postoperatively
Readmission to the hospital
Patients will be called and asked for any readmission to a hospital (yes /no)
Time frame: 90 days postoperatively
Weight change
Weight (Day before surgery) - Weight (10 days postoperatively)
Time frame: The day before surgery until postoperative day 10
Body mass index (BMI) change
BMI (day before surgery) - BMI (10 days postoperatively)
Time frame: The day before surgery until postoperative day 10
International normalized ration (INR) change
INR (Day before surgery) - INR (10 days postoperatively)
Time frame: The day before surgery until postoperative day 10
Albumin change
Albumin level (Day before surgery) - Albumin level (10 days postoperatively)
Time frame: The day before surgery until postoperative day 10
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Postoperative cortisol level
Cortisol levels will be compared between group A and B
Time frame: 8 days postoperatively
Freiburg index of patient satisfaction
Patient satisfaction will be measured using a standardized questionnaire
Time frame: Postoperative day 10