Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial
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|ClinicalTrials.gov Identifier: NCT02230436|
Recruitment Status : Unknown
Verified August 2016 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : September 3, 2014
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatectomy Post Procedural Discharge||Other: Early drain removal Other: Late drain removal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Early Versus Late Drain Removal on Postoperative Morbidity After Pancreatectomy: A Randomized Prospective Trial|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Early drain removal
Removing drain(s) on postoperative day 3 (n = 72)
Other: Early drain removal
Removing drain(s) on postoperative day 3
Experimental: Late drain removal
Removing drain(s) on postoperative day 4 or later (n = 72)
Other: Late drain removal
Removing drain(s) on postoperative day 4 or later
- Intra-abdominal infection [ Time Frame: Up to postoperative 30 days ]Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
- Pancreatic fistula [ Time Frame: Up to postoperative 30 days ]The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
- Intra-abdominal bleeding [ Time Frame: Up to postoperative 30 days ]The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
- Delayed gastric emptying [ Time Frame: Up to postoperative 30 days ]The International Study Group of Pancreatic Surgery (ISGPS) definition: Inability to return to a standard diet by the end of the first postoperative week with prolonged nasogastric intubation.
- Pulmonary complications [ Time Frame: Up to postoperative 30 days ]Including pulmonary infection and atelectasis.
- Length of hospital stay (day) [ Time Frame: Up to postoperative 2 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230436
|Contact: Menghua Dai, M.D.||email@example.com|
|Contact: Ning Shi, M.D.||firstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, China, 100730|
|Contact: Menghua Dai, M.D. email@example.com|
|Study Chair:||Menghua Dai, M.D.||Peking Union Medical College Hospital|