An interventional study of Laparoscopic cholecystectomy with drain insertion in Acute Cholecystitis, Empyema of Gallbladder and Abscess of Gallbladder, sponsored by Seoul St. Mary's Hospital. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2014-12-03.
Sponsored by Seoul St. Mary's Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Procedure: Laparoscopic cholecystectomy with drain insertion
In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space
Complication
complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.
Time frame: 2 weeks
Operative Time
Time frame: 1day
Postoperative Hospital Stay
Time frame: 2weeks
Postoperative Pain Score
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.
Time frame: 6hr after operation - 24hr after operation - 48hr after operation
| Milestone | Drain Insertion | no Drain Insertion |
|---|---|---|
| Started | 98 | 100 |
| Completed | 94 | 99 |
| Not completed | 4 | 1 |
| Withdrew: Withdrawal by subject | 4 | 1 |
complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.
| participants | no Drain Insertion | Drain Insertion |
|---|---|---|
| Complication | 7 | 7 |
| minutes | Drain Insertion | no Drain Insertion |
|---|---|---|
| Operative Time | 47.8 ± 17.7 | 43.1 ± 17.1 |
| day | Drain Insertion | no Drain Insertion |
|---|---|---|
| Postoperative Hospital Stay | 2.5 ± 1.4 | 2.3 ± 0.8 |
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.
| units on a scale | Drain Insertion | no Drain Insertion |
|---|---|---|
| 6hr after operation | 5.0 ± 2.2 | 5.2 ± 2.4 |
| 24hr after operation | 3.9 ± 1.4 | 3.3 ± 2.0 |
| 48hr after operation | 2.1 ± 1.5 | 1.5 ± 1.4 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Drain Insertion | — | 0/98 (0%) | 9/94 (9.6%) |
| no Drain Insertion | — | 0/100 (0%) | 9/99 (9.1%) |
| Event | Drain Insertion | no Drain Insertion |
|---|---|---|
| wound infectionSkin and subcutaneous tissue disorders | 4/94 | 3/99 |
| prolonged postoperative shoulder painGeneral disorders | 4/94 | 3/99 |
| voiding difficultyRenal and urinary disorders | 1/94 | 3/99 |
| Age, Continuous(years) | Drain Insertion | no Drain Insertion | Total |
|---|---|---|---|
| Mean | 58 ± 15.6 | 50 ± 15.9 | 54 ± 16.3 |
| Sex: Female, Male(Participants) | Drain Insertion | no Drain Insertion | Total |
|---|---|---|---|
| Female | 44 | 48 | 92 |
| Male | 54 | 52 | 106 |
| Region of Enrollment(participants) | Drain Insertion | no Drain Insertion | Total |
|---|---|---|---|
| Korea, Republic of | 98 | 100 | 198 |
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Seoul St. Mary's Hospital