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
Among 13 studies in Cholecystitis, Acute with a site in Korea, Republic of — 1 open to participants now, 1 under way, none of them phase 3. Cholecystitis, Acute · Korea, Republic of.
Among the 13 studies in Cholecystitis, Acute with a site in Korea, Republic of, this one is the 4th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2013, is one of 10 with no phase, and was the 3rd registered.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
Browse Cholecystitis, Acute studies →1 of the 13 studies in Cholecystitis, Acute with a site in Korea, Republic of is open now. Recruiting first, the newest first:
Seoul National University Hospital · Sites in Korea, Republic of
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 20 Cholecystitis, Acute studies recruiting now, 16 (80%) set no upper age limit and 2 (10%) stop at 75 or younger; 2 take children under 18; 0 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2013.
This study's enrollment of 198 is above the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.
Median enrollment 176 across the 12 interventional studies, 82 across the 1 observational. Of the 7 that completed or were terminated, 2 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 13 has an industry lead sponsor. The 8 most frequent:
Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.
Seoul St. Mary's Hospital has 4 studies filed under Cholecystitis, Acute — fewer than ten, so there is no comparison to draw.
1 of the studies in Cholecystitis, Acute with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06287112Seoul National University HospitalPrevention of Acute Cholecystitis With ETGBD | 2027-02-20 |
Among the 13 studies in Cholecystitis, Acute with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 |
The record gives a start of Nov 2013, a primary completion of Sep 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2014, 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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