Trial Outcomes & Findings for Drain After Elective Laparoscopic Cholecystectomy (NCT NCT00986544)

Results Overview

An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

106 participants

Primary outcome timeframe

first postoperative day

Results posted on

2012-03-23

Participant Flow

From December 1, 2009 to December 31, 2010 patients were submitted to laparoscopic cholecystectomy in Hospital "P.Colombo", Velletri, Italy; University of Rome "La Sapienza"- Polo Pontino, Terracina, Italy; Obafemi Awolowo University, Ile-Ife, Nigeria.

Patients with acute cholecystitis, cholangitis, or pancreatitis were excluded. If intraoperative common bile duct exploration or any other additional procedure were performed, patients were also excluded

Participant milestones

Participant milestones
Measure	Absence of Drain After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.	Drain drain positioned in the subhepatic space after laparoscopic cholecystectomy
Overall Study STARTED	53	53
Overall Study COMPLETED	53	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drain After Elective Laparoscopic Cholecystectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Absence of Drain n=53 Participants After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.	Drain n=53 Participants drain positioned in the subhepatic space after laparoscopic cholecystectomy	Total n=106 Participants Total of all reporting groups
Region of Enrollment Italy	53 participants n=93 Participants	53 participants n=4 Participants	106 participants n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=93 Participants	34 Participants n=4 Participants	72 Participants n=27 Participants
Age, Categorical >=65 years	15 Participants n=93 Participants	19 Participants n=4 Participants	34 Participants n=27 Participants
Age Continuous	47.1 years STANDARD_DEVIATION 16.7 • n=93 Participants	48.6 years STANDARD_DEVIATION 14.2 • n=4 Participants	47.8 years STANDARD_DEVIATION 15.4 • n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	42 Participants n=4 Participants	82 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	11 Participants n=4 Participants	24 Participants n=27 Participants

PRIMARY outcome

Timeframe: first postoperative day

Population: An intention to treat (ITT) analysis was performed.

An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.

Outcome measures

Outcome measures
Measure	Absence of Drain n=53 Participants After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.	Drain n=53 Participants Drain positioned in the subhepatic space after laparoscopic cholecystectomy
Number of Participants With Subhepatic Collection at Ultrasonographic Examination	45 Participants	46 Participants

SECONDARY outcome

Timeframe: 1 month

Population: Intention to treat analysis

Outcome measures

Outcome measures
Measure	Absence of Drain n=53 Participants After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.	Drain n=53 Participants Drain positioned in the subhepatic space after laparoscopic cholecystectomy
Number of Participants With Postoperative Complications	3 participants	4 participants

Adverse Events

Absence of Drain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcello Picchio

Department of Surgery, Hospital "P. Colombo", Via Orti Ginnetti 7, 00049 Velletri (Rome), Italy

Phone: +39696102228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place