Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

NCT ID: NCT00886210

Last Updated: 2009-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

intra abdominal drain

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

LC without drain

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Group A; Group B

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mansoura University

Principal Investigators

Ayman Elnakeeb, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Ayman Elnakeeb

Al Mansurah, , Egypt

Countries

Egypt

References

Hawasli A, Brown E. The effect of drains in laparoscopic cholecystectomy. J Laparoendosc Surg. 1994 Dec;4(6):393-8. doi: 10.1089/lps.1994.4.393.

Reference Type: RESULT

PMID: 7881142 (View on PubMed)

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. doi: 10.1007/s00534-007-1221-x. Epub 2007 Nov 30.

Reference Type: RESULT

PMID: 18040619 (View on PubMed)

Related Links

http://home.mans.eun.eg/

Mansoura university hospital

Other Identifiers

abdominal drainage

Identifier Type: -

Identifier Source: org_study_id