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Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00886210
First received: April 20, 2009
Last updated: April 21, 2009
Last verified: April 2009

April 20, 2009
April 21, 2009
October 2006
March 2008   (final data collection date for primary outcome measure)
pain, nausea and vomiting [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00886210 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy
Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy. A Prospective Randomized Study

Patients and methods: 100 patients were included in this study. They divided into two groups, group (A) with drain and group (B) without drain. The investigators recorded the effect of drainage on, postoperative pain (Po-P) using visual analogue scale VAS at 6, 24, 48 hours and 1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection, hospital stay, chest complication, and postoperative body temperature.

The patients were randomized into two groups using enclosed envelope. Group (A) with drain included 50 patients, and group (B) without drain included 50 patients.

Under general anesthesia, and same antibiotics (3rd generation cephalosporin) Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group A nelton catheter (no 20) was inserted at the end of operation.

The Intraoperative parameter observed included duration of the operation, amount of CO2 used in the operation, bile escape, saline irrigation during operation and volume of blood loss were recorded.

The patients started oral feeding 8 hours (h) postoperatively; abdominal ultrasound was done for all patients in both groups on day of discharge to show any collection or free fluid in the abdomen. The patients were usually discharged after removal of drain, and when the patient surgically free.

Postoperative pain was evaluated at 6 h, 24 h, 48, 1 week after operation using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 (severe pain). Postoperative analgesia in the form of non steroidal anti-inflammatory drug (NSAID) was administered intramuscularly when required. If the patients still complained of pain and required strong analgesic, (1 mg/kg pethidine intramuscularly) was administered. The total dose of these medications were recorded.

Postoperative maximum body temperatures were recorded at (6 h, 24 h, and 48 h) for all patients.

PONV were assessed postoperative after 6 h, 24 h and after 48 h. Metocloprpamide was given if the patients required reduction of nausea and the total dose of this medication was recorded. The frequency of vomiting was recorded.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Abdominal Drainage
  • Laparoscopic Cholecystectomy
  • Gall Stones
  • Procedure: intra abdominal drain
    Under general anesthesia, and same antibiotics (3rd generation cephalosporin). Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group A nelton catheter (no 20) inserted at the end of operation.
    Other Name: Group A
  • Procedure: LC without drain
    Under general anesthesia, and same antibiotics (3rd generation cephalosporin). Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group no drain at the end of operation.
    Other Name: Group B
  • Active Comparator: 1LC with drain
    Under general anesthesia, and same antibiotics (3rd generation cephalosporin). Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group A nelton catheter (no 20) inserted at the end of operation.
    Intervention: Procedure: intra abdominal drain
  • Active Comparator: 2LC without drain
    Under general anesthesia, and same antibiotics (3rd generation cephalosporin). Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. no drain at the end of operation.
    Intervention: Procedure: LC without drain

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with gallbladder stones and laparoscopic cholecystectomy

Exclusion Criteria:

  • patients above 80 years old
  • patients with acute cholecystitis
  • patients with history of upper laparotomy
  • patients with a hemorrhagic tendency due to cirrhosis
  • patients refused to give informed consent and patients who were converted to open cholecystectomy
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT00886210
abdominal drainage
Yes
Mansoura University
Mansoura University
Not Provided
Principal Investigator: Ayman Elnakeeb, MD mansoura university hospital
Mansoura University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP