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Effects of Drainage in Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02027402
Recruitment Status : Completed
First Posted : January 6, 2014
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Incheon St.Mary's Hospital
Information provided by (Responsible Party):
Taeho Hong, Seoul St. Mary's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Acute Cholecystitis
Empyema of Gallbladder
Abscess of Gallbladder
Intervention Procedure: Laparoscopic cholecystectomy with drain insertion
Enrollment 198
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drain Insertion no Drain Insertion
Hide Arm/Group Description

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.

In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Period Title: Overall Study
Started 98 100
Completed 94 99
Not Completed 4 1
Reason Not Completed
Withdrawal by Subject             4             1
Arm/Group Title Drain Insertion no Drain Insertion Total
Hide Arm/Group Description

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.

In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain Total of all reporting groups
Overall Number of Baseline Participants 98 100 198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 100 participants 198 participants
58  (15.6) 50  (15.9) 54  (16.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 100 participants 198 participants
Female
44
  44.9%
48
  48.0%
92
  46.5%
Male
54
  55.1%
52
  52.0%
106
  53.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 98 participants 100 participants 198 participants
98 100 198
1.Primary Outcome
Title Complication
Hide Description complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Drain Insertion Drain Insertion
Hide Arm/Group Description:
In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain

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.

Overall Number of Participants Analyzed 99 94
Measure Type: Number
Unit of Measure: participants
7 7
2.Secondary Outcome
Title Operative Time
Hide Description [Not Specified]
Time Frame 1day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drain Insertion no Drain Insertion
Hide Arm/Group Description:

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.

In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Overall Number of Participants Analyzed 94 99
Mean (Standard Deviation)
Unit of Measure: minutes
47.8  (17.7) 43.1  (17.1)
3.Secondary Outcome
Title Postoperative Hospital Stay
Hide Description [Not Specified]
Time Frame 2weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drain Insertion no Drain Insertion
Hide Arm/Group Description:

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.

In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Overall Number of Participants Analyzed 94 99
Mean (Standard Deviation)
Unit of Measure: day
2.5  (1.4) 2.3  (0.8)
4.Secondary Outcome
Title Postoperative Pain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drain Insertion no Drain Insertion
Hide Arm/Group Description:

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.

In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Overall Number of Participants Analyzed 94 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drain Insertion no Drain Insertion
Hide Arm/Group Description

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.

In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
All-Cause Mortality
Drain Insertion no Drain Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Drain Insertion no Drain Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/100 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drain Insertion no Drain Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   9/94 (9.57%)   9/99 (9.09%) 
General disorders     
prolonged postoperative shoulder pain   4/94 (4.26%)  3/99 (3.03%) 
Renal and urinary disorders     
voiding difficulty   1/94 (1.06%)  3/99 (3.03%) 
Skin and subcutaneous tissue disorders     
wound infection   4/94 (4.26%)  3/99 (3.03%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Teaho Hong
Organization: Seoul St Mary's hospital
Phone: 821052065266
EMail: gshth@catholic.ac.kr
Layout table for additonal information
Responsible Party: Taeho Hong, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02027402    
Other Study ID Numbers: seoul -S2
First Submitted: December 30, 2013
First Posted: January 6, 2014
Results First Submitted: November 23, 2014
Results First Posted: December 3, 2014
Last Update Posted: December 3, 2014