Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absence of drain | Sham Comparator |
| |
| Drain | Active Comparator | drain positioned in the subhepatic space after laparoscopic cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no drain | Procedure | drain positioned on the skin |
| |
| drain positioned |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | first postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Complications | 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erasmo Spaziani, PhD | University of Rome "La Sapienza"- Polo Pontino | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rome "La Sapienza" - Polo Pontino | Terracina | Latina | 04019 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17943873 | Background | Gurusamy KS, Samraj K, Mullerat P, Davidson BR. Routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006004. doi: 10.1002/14651858.CD006004.pub3. | |
| 18926516 | Background | Tzovaras G, Liakou P, Fafoulakis F, Baloyiannis I, Zacharoulis D, Hatzitheofilou C. Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled randomized trial. Am J Surg. 2009 Jun;197(6):759-63. doi: 10.1016/j.amjsurg.2008.05.011. Epub 2008 Oct 16. |
Not provided
Not provided
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
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Absence of Drain | After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space. |
| FG001 | Drain | drain positioned in the subhepatic space after laparoscopic cholecystectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Absence of Drain | After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space. |
| BG001 | Drain | drain positioned in the subhepatic space after laparoscopic cholecystectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | An intention to treat (ITT) analysis was performed. | Posted | Number | Participants | first postoperative day |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Absence of Drain | After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcello Picchio | Department of Surgery, Hospital "P. Colombo", Via Orti Ginnetti 7, 00049 Velletri (Rome), Italy | +39696102228 | marcellopicchio@libero.it |
Not provided
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
drain positioned in the subhepatic space |
|
| drain not positioned | Procedure | Drain positioned in the abdominal wall |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Postoperative Complications | Intention to treat analysis | Posted | Number | participants | 1 month |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Drain | drain positioned in the subhepatic space after laparoscopic cholecystectomy | 0 | 53 | 0 | 53 |
Not provided
Not provided