Trial Outcomes & Findings for Effects of Drainage in Laparoscopic Cholecystectomy (NCT NCT02027402)

NCT ID: NCT02027402

Last Updated: 2014-12-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 198 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2014-12-03

Participant Flow

Participant milestones

Measure	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.	no Drain Insertion In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Overall Study STARTED	98	100
Overall Study COMPLETED	94	99
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	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.	no Drain Insertion In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Overall Study Withdrawal by Subject	4	1

Baseline Characteristics

Effects of Drainage in Laparoscopic Cholecystectomy

Baseline characteristics by cohort

Measure	Drain Insertion n=98 Participants 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.	no Drain Insertion n=100 Participants In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain	Total n=198 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 15.6 • n=5 Participants	50 years STANDARD_DEVIATION 15.9 • n=7 Participants	54 years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	48 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	52 Participants n=7 Participants	106 Participants n=5 Participants
Region of Enrollment Korea, Republic of	98 participants n=5 Participants	100 participants n=7 Participants	198 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	no Drain Insertion n=99 Participants In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain	Drain Insertion n=94 Participants 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.
Complication	7 participants	7 participants

SECONDARY outcome

Timeframe: 1day

Outcome measures

Measure	no Drain Insertion n=94 Participants In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain	Drain Insertion n=99 Participants 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.
Operative Time	47.8 minutes Standard Deviation 17.7	43.1 minutes Standard Deviation 17.1

SECONDARY outcome

Timeframe: 2weeks

Outcome measures

Measure	no Drain Insertion n=94 Participants In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain	Drain Insertion n=99 Participants 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.
Postoperative Hospital Stay	2.5 day Standard Deviation 1.4	2.3 day Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	no Drain Insertion n=94 Participants In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain	Drain Insertion n=99 Participants 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.
Postoperative Pain Score 6hr after operation	5.0 units on a scale Standard Deviation 2.2	5.2 units on a scale Standard Deviation 2.4
Postoperative Pain Score 24hr after operation	3.9 units on a scale Standard Deviation 1.4	3.3 units on a scale Standard Deviation 2.0
Postoperative Pain Score 48hr after operation	2.1 units on a scale Standard Deviation 1.5	1.5 units on a scale Standard Deviation 1.4

Adverse Events

Drain Insertion

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

no Drain Insertion

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Drain Insertion n=94 participants at risk；n=98 participants at risk 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.	no Drain Insertion n=99 participants at risk；n=100 participants at risk In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
Skin and subcutaneous tissue disorders wound infection	4.3% 4/94 • 2 weeks	3.0% 3/99 • 2 weeks
Renal and urinary disorders voiding difficulty	1.1% 1/94 • 2 weeks	3.0% 3/99 • 2 weeks
General disorders prolonged postoperative shoulder pain	4.3% 4/94 • 2 weeks	3.0% 3/99 • 2 weeks

Additional Information

Teaho Hong

Seoul St Mary's hospital

Phone: 821052065266

Email: gshth@catholic.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place