Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886210
• Other study ID #: abdominal drainage
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: April 21, 2009
• Start date: October 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2009
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Drainage
• Gall Stones
• Laparoscopic Cholecystectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Ayman Elnakeeb	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Hawasli A, Brown E. The effect of drains in laparoscopic cholecystectomy. J Laparoendosc Surg. 1994 Dec;4(6):393-8. — View Citation

Uchiyama K, Tani M, Kawai M, Terasawa H, Hama T, Yamaue H. Clinical significance of drainage tube insertion in laparoscopic cholecystectomy: a prospective randomized controlled trial. J Hepatobiliary Pancreat Surg. 2007;14(6):551-6. Epub 2007 Nov 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain, nausea and vomiting		30 days postoperative	Yes

External Links

•   Mansoura university hospital