NCT00886210

Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy. A Prospective Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Abdominal Drainage
• Laparoscopic Cholecystectomy
• Gall Stones

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2009-04-22
• Last updated: 2009-04-22

Locations

1 site across 1 country: Egypt