Effects of Drainage in Laparoscopic Cholecystectomy

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Brief Title

Effects of Drainage in Laparoscopic Cholecystectomy

Official Title

To Drain or Not to Drain in Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder ; a Multicenter Randomized Controlled Trial

Brief Summary

      During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely
      insert a drain. However, no consensus has been reached regarding the need for drainage in
      these cases, and the use of a drain remains controversial. This study is coordinated to find
      out the surgical outcomes and perioperative morbidity according to the insertion of drain
      after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain
      after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects
      on the postoperative morbidity.
    

Detailed Description

      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, [4] 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


Primary Outcome

Complication

Secondary Outcome

 Operative Time

Condition

Acute Cholecystitis

Intervention

Laparoscopic cholecystectomy with drain insertion

Study Arms / Comparison Groups

 Drain insertion
Description:  Laparoscopic cholecystectomy with drain insertion is performed in this arm.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

198

Start Date

November 2013

Completion Date

October 2014

Primary Completion Date

September 2014

Eligibility Criteria

        Inclusion Criteria:

          -  acutely inflamed gallbladder

        Exclusion Criteria:

          -  chronic cholecystitis

          -  gallbladder polyp or gallbladder cancer

          -  the patient who underwent reduced port surgery

          -  the patient who underwent common bile duct exploration during the operation

          -  the patient who underwent concurrent operation

          -  the patient who had past history of upper abdominal surgery

          -  the patient who had a immunodeficiency state

          -  the case which had a suspicion of delayed bile leakage

          -  the case which had a incomplete cystic duct ligation

          -  the patient who underwent open conversion surgery during the operation

          -  the patient who had a high risk of bleeding
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Taeho Hong, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02027402

Organization ID

seoul -S2


Responsible Party

Principal Investigator

Study Sponsor

Seoul St. Mary's Hospital

Collaborators

 Incheon St.Mary's Hospital

Study Sponsor

Taeho Hong, Principal Investigator, SeoulSt.Mary's hospital


Verification Date

November 2014