Effects of Drainage in Laparoscopic Cholecystectomy

• Sponsor: Seoul St. Mary's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02027402
• Collaborator: Incheon St.Mary's Hospital (Other)
• Enrollment: 198
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 18

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis; Empyema of Gallbladder; Abscess of Gallbladder	Procedure: Laparoscopic cholecystectomy with drain insertion	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: To Drain or Not to Drain in Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder ; a Multicenter Randomized Controlled Trial
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drain insertion Laparoscopic cholecystectomy with drain insertion is performed in this arm.	Procedure: 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 right subhepatic space
No Intervention: no drain insertion In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain

Outcome Measures

Primary Outcome Measures

1. Complication [2 weeks]

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

Secondary Outcome Measures

1. Operative Time [1day]

2. Postoperative Hospital Stay [2weeks]

3. Postoperative Pain Score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of HBP Surgery, Seoul St. Mary's hospital	Seoul	Seocho-gu, Banopo-dong	Korea, Republic of	137-701

Sponsors and Collaborators

• Seoul St. Mary's Hospital
• Incheon St.Mary's Hospital

Investigators

• Principal Investigator: Taeho Hong, SeoulSt.Mary's hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taeho Hong, Assistant proffesor, Seoul St. Mary's Hospital
• ClinicalTrials.gov Identifier: NCT02027402
• Other Study ID Numbers: seoul -S2
• First Posted: Jan 6, 2014
• Last Update Posted: Dec 3, 2014
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Empyema; Cholecystitis; Cholecystitis, Acute

Study Results

Participant Flow

Arm/Group Title	Drain Insertion	no Drain Insertion
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

Baseline Characteristics

Arm/Group Title	Drain Insertion	no Drain Insertion	Total
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 Participants	98	100	198
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (15.6)	50 (15.9)	54 (16.3)
Sex: Female, Male (Count of Participants)
Female	44 44.9%	48 48%	92 46.5%
Male	54 55.1%	52 52%	106 53.5%
Region of Enrollment (participants) [Number]
Korea, Republic of	98 100%	100 100%	198 100%

Outcome Measures

1. Primary Outcome

Title	Complication
Description	complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	no Drain Insertion	Drain Insertion
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.
Measure Participants	99	94
Number [participants]	7 7.1%	7 7%

2. Secondary Outcome

Title	Operative Time
Time Frame	1day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drain Insertion	no Drain Insertion
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
Measure Participants	94	99
Mean (Standard Deviation) [minutes]	47.8 (17.7)	43.1 (17.1)

3. Secondary Outcome

Title	Postoperative Hospital Stay
Time Frame	2weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drain Insertion	no Drain Insertion
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
Measure Participants	94	99
Mean (Standard Deviation) [day]	2.5 (1.4)	2.3 (0.8)

4. Secondary Outcome

Title	Postoperative Pain Score
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drain Insertion	no Drain Insertion
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
Measure Participants	94	99
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)

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Drain Insertion		no Drain Insertion
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Drain Insertion		no Drain Insertion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Drain Insertion		no Drain Insertion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/94 (9.6%)		9/99 (9.1%)
General disorders
prolonged postoperative shoulder pain	4/94 (4.3%)		3/99 (3%)
Renal and urinary disorders
voiding difficulty	1/94 (1.1%)		3/99 (3%)
Skin and subcutaneous tissue disorders
wound infection	4/94 (4.3%)		3/99 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.