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Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

Primary Purpose

Abdominal Drainage, Laparoscopic Cholecystectomy, Gall Stones

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intra abdominal drain
LC without drain
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Drainage focused on measuring drain, laparoscopic cholecystectomy, pneumoperitonum

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ayman Elnakeeb

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1LC with drain

2LC without drain

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

pain, nausea and vomiting

Secondary Outcome Measures

Full Information

First Posted
April 20, 2009
Last Updated
April 21, 2009
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT00886210
Brief Title
Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy
Official Title
Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy. A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Drainage, Laparoscopic Cholecystectomy, Gall Stones
Keywords
drain, laparoscopic cholecystectomy, pneumoperitonum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1LC with drain
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2LC without drain
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
intra abdominal drain
Other Intervention Name(s)
Group A
Intervention Description
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
Intervention Name(s)
LC without drain
Other Intervention Name(s)
Group B
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain, nausea and vomiting
Time Frame
30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Elnakeeb, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman Elnakeeb
City
Mansoura
ZIP/Postal Code
335111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
7881142
Citation
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.
Results Reference
result
PubMed Identifier
18040619
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. doi: 10.1007/s00534-007-1221-x. Epub 2007 Nov 30.
Results Reference
result
Links:
URL
http://home.mans.eun.eg/
Description
Mansoura university hospital

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Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

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