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Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00886210
Enrollment
100
Registered
2009-04-22
Start date
2006-10-31
Completion date
2008-03-31
Last updated
2009-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Drainage, Gall Stones, Laparoscopic Cholecystectomy

Keywords

drain, laparoscopic cholecystectomy, pneumoperitonum

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.

Interventions

PROCEDUREintra 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.

PROCEDURELC 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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
pain, nausea and vomiting30 days postoperative

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026