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Effects of Drainage in Laparoscopic Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02027402
Enrollment
198
Registered
2014-01-06
Start date
2013-11-30
Completion date
2014-10-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscess of Gallbladder, Acute Cholecystitis, Empyema of Gallbladder

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.

Interventions

PROCEDURELaparoscopic 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

Sponsors

Incheon St.Mary's Hospital
CollaboratorOTHER
Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Complication2 weekscomplication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.

Secondary

MeasureTime frameDescription
Operative Time1day
Postoperative Hospital Stay2weeks
Postoperative Pain Score6hr after operation - 24hr after operation - 48hr after operationPostoperative 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.

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Drain Insertion
Laparoscopic cholecystectomy with drain insertion is performed in this arm. 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 Morrison's pouch.
98
no Drain Insertion
In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
100
Total198

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject41

Baseline characteristics

CharacteristicDrain Insertionno Drain InsertionTotal
Age, Continuous58 years
STANDARD_DEVIATION 15.6
50 years
STANDARD_DEVIATION 15.9
54 years
STANDARD_DEVIATION 16.3
Region of Enrollment
Korea, Republic of
98 participants100 participants198 participants
Sex: Female, Male
Female
44 Participants48 Participants92 Participants
Sex: Female, Male
Male
54 Participants52 Participants106 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
9 / 949 / 99
serious
Total, serious adverse events
0 / 980 / 100

Outcome results

Primary

Complication

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

Time frame: 2 weeks

ArmMeasureValue (NUMBER)
no Drain InsertionComplication7 participants
Drain InsertionComplication7 participants
Secondary

Operative Time

Time frame: 1day

ArmMeasureValue (MEAN)Dispersion
no Drain InsertionOperative Time47.8 minutesStandard Deviation 17.7
Drain InsertionOperative Time43.1 minutesStandard Deviation 17.1
Secondary

Postoperative Hospital Stay

Time frame: 2weeks

ArmMeasureValue (MEAN)Dispersion
no Drain InsertionPostoperative Hospital Stay2.5 dayStandard Deviation 1.4
Drain InsertionPostoperative Hospital Stay2.3 dayStandard Deviation 0.8
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
no Drain InsertionPostoperative Pain Score6hr after operation5.0 units on a scaleStandard Deviation 2.2
no Drain InsertionPostoperative Pain Score24hr after operation3.9 units on a scaleStandard Deviation 1.4
no Drain InsertionPostoperative Pain Score48hr after operation2.1 units on a scaleStandard Deviation 1.5
Drain InsertionPostoperative Pain Score6hr after operation5.2 units on a scaleStandard Deviation 2.4
Drain InsertionPostoperative Pain Score24hr after operation3.3 units on a scaleStandard Deviation 2
Drain InsertionPostoperative Pain Score48hr after operation1.5 units on a scaleStandard Deviation 1.4

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026