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OpenTrials
Completed

NCT Number: NCT02027402

Effects of Drainage in Laparoscopic Cholecystectomy

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of HBP Surgery, Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic cholecystectomy with drain insertion

Procedure

In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space

Primary outcomes

  1. Complication

    Time frame: 2 weeks

    complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.

Secondary outcomes

  1. Operative Time

    Time frame: 1day

  2. Postoperative Hospital Stay

    Time frame: 2weeks

  3. 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.

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • Incheon St.Mary's Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2014
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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