NCT00886210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

Enrollment Period

1.4 years

First QC Date

April 20, 2009

Last Update Submit

April 21, 2009

Conditions

Abdominal DrainageLaparoscopic CholecystectomyGall Stones

Keywords

drainlaparoscopic cholecystectomypneumoperitonum

Outcome Measures

Primary Outcomes (1)

  • pain, nausea and vomiting

    30 days postoperative

Study Arms (2)

1LC with drain

ACTIVE COMPARATOR

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: intra abdominal drain

2LC without drain

ACTIVE COMPARATOR

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.

Procedure: LC without drain

Interventions

intra abdominal drainPROCEDURE

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.

Also known as: Group A
1LC with drain
LC without drainPROCEDURE

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.

Also known as: Group B
2LC without drain

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with gallbladder stones and laparoscopic cholecystectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Elnakeeb

Al Mansurah, 335111, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 7881142RESULT

  • 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.

    PMID: 18040619RESULT

Related Links

MeSH Terms

Conditions

Gallstones

Interventions

Drainage

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • Ayman Elnakeeb, MD

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

October 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations

EG(1)