Cholelithiasis
Conditions
Keywords
Laparoscopy, cholecystectomy, drainage
Brief summary
The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.
Detailed description
After laparoscopic gallbladder removal patients are randomized to have a suction drain positioned in the subhepatic space or to have a sham drain in the subhepatic space. The primary outcome measure will be the presence of subhepatic fluid collection at ultrasonographic examination on the first postoperative day. Secondary outcome measures will be postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting and morbidity
Interventions
PROCEDUREno drain
drain positioned on the skin
PROCEDUREdrain positioned
drain positioned in the subhepatic space
PROCEDUREdrain not positioned
Drain positioned in the abdominal wall
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* elective laparoscopic cholecystectomy
Exclusion criteria
* acute cholecystitis, cholangitis, or pancreatitis * no contraindication for the laparoscopic * no other additional procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Subhepatic Collection at Ultrasonographic Examination | first postoperative day | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Postoperative Complications | 1 month |
Countries
Italy
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Absence of Drain After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space. | 53 |
| Drain drain positioned in the subhepatic space after laparoscopic cholecystectomy | 53 |
| Total | 106 |
Baseline characteristics
| Characteristic | Drain | Total | Absence of Drain |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 34 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 72 Participants | 38 Participants |
| Age Continuous | 48.6 years STANDARD_DEVIATION 14.2 | 47.8 years STANDARD_DEVIATION 15.4 | 47.1 years STANDARD_DEVIATION 16.7 |
| Region of Enrollment Italy | 53 participants | 106 participants | 53 participants |
| Sex: Female, Male Female | 42 Participants | 82 Participants | 40 Participants |
| Sex: Female, Male Male | 11 Participants | 24 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 | 0 / 53 |
Outcome results
Primary
Number of Participants With Subhepatic Collection at Ultrasonographic Examination
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.
Time frame: first postoperative day
Population: An intention to treat (ITT) analysis was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absence of Drain | Number of Participants With Subhepatic Collection at Ultrasonographic Examination | 45 Participants |
| Drain | Number of Participants With Subhepatic Collection at Ultrasonographic Examination | 46 Participants |
Secondary
Number of Participants With Postoperative Complications
Time frame: 1 month
Population: Intention to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absence of Drain | Number of Participants With Postoperative Complications | 3 participants |
| Drain | Number of Participants With Postoperative Complications | 4 participants |