Effects of Drainage in Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT02027402|
Recruitment Status : Completed
First Posted : January 6, 2014
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Cholecystitis Empyema of Gallbladder Abscess of Gallbladder||Procedure: Laparoscopic cholecystectomy with drain insertion||Not Applicable|
Drain has been widely used in many abdominal surgeries for therapeutic purposes such as the removal of infected debris or abscess, and supporting the healing of leakage or fistula. Although the usability of therapeutic drain is commonly accepted, the efficacy of prophylactic drain still has been debated. Most surgeons have inserted prophylactic drain with expectations that the drain would be helpful for early detection of postoperative bleeding or leakage, and also prevention of intra-abdominal abscess through removing debris or curd. However, there are only few evidence-based studies for the actual effectiveness of prophylactic drain and the objections against the routine use of drain have been raised.
Most surgeons have placed the drain after cholecystectomy with expectations that it could help to detect postoperative bleeding or bile leakage and prevent intra-abdominal infection. However, there is a lack of evidence regarding the role of drain in laparoscopic cholecystectomy for acutely inflamed gallbladder and surgeons have placed the drain based on their experiences and beliefs, not on evidence-based guidelines. In the previous retrospective study,  we described that the routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder has no advantage to detect bile leak or bleeding and it was no helpful to prevent the postoperative morbidities such as intra-abdominal abscess or wound infection. The aim of present multicenter trial is to assess the value of routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder in a large, randomized controlled prospective study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||To Drain or Not to Drain in Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder ; a Multicenter Randomized Controlled Trial|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Drain insertion
Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Procedure: Laparoscopic cholecystectomy with drain insertion
In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space
No Intervention: no drain insertion
In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
- Complication [ Time Frame: 2 weeks ]complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.
- Operative Time [ Time Frame: 1day ]
- Postoperative Hospital Stay [ Time Frame: 2weeks ]
- Postoperative Pain Score [ Time Frame: 6hr after operation - 24hr after operation - 48hr after operation ]Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027402
|Korea, Republic of|
|Department of HBP Surgery, Seoul St. Mary's hospital|
|Seoul, Seocho-gu, Banopo-dong, Korea, Republic of, 137-701|
|Principal Investigator:||Taeho Hong||SeoulSt.Mary's hospital|