Subcostal port reduces port site incisional hernia in laparoscopic cholecystectomy

Last registered on March 14, 2016

Pre-Trial

Trial Information

General Information

Title
Subcostal port reduces port site incisional hernia in laparoscopic cholecystectomy
RCT ID
AEARCTR-0001121
Initial registration date
March 14, 2016

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
March 14, 2016, 8:42 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation
DONCASTER ROYAL INFIRMARY

Other Primary Investigator(s)

Additional Trial Information

Status
In development
Start date
2016-03-15
End date
2016-06-15
Secondary IDs
Abstract
Background:
Port site incisional hernia is one of the complications of laparoscopic surgery with an incidence of 1-5%.
The aim of this study is to investigate the efficacy of subcostal port to reduce or prevent port site hernia
Methods:100 patients are recruited for each arm of the study.One group with subcostal port ,the other without.A follow up period of 6-12 months is arranged.
Results: Primary end point of port site incisional hernia is assessed.Secondary point would be bile duct injury,bleeding,re operation and mortality.
Conclusion:Port site incisional hernia is reduced/no difference or increased with the use of subcostal port
External Link(s)

Registration Citation

Citation
HUSSAIN, ABDULZAHRA. 2016. "Subcostal port reduces port site incisional hernia in laparoscopic cholecystectomy." AEA RCT Registry. March 14. https://doi.org/10.1257/rct.1121-1.0
Former Citation
HUSSAIN, ABDULZAHRA. 2016. "Subcostal port reduces port site incisional hernia in laparoscopic cholecystectomy." AEA RCT Registry. March 14. https://www.socialscienceregistry.org/trials/1121/history/7254
Experimental Details

Interventions

Intervention(s)
Laproscopic cholecystectomy is a procedure to remove the gall bladder for different indications including gall stone disease.
It is common elective operation with about 60,000 procedure per year in the UK.
The operation is usually performed through 4 key-holes localised to umbilicus ,left side of abdomen and epigastrium.
It has been associated with post operative complication of an incisional hernia at the key-holes.
The intervention in this study is using subcostal port to dissect and extract the gall bladder .No epigastric port is used.
Intervention Start Date
2016-03-15
Intervention End Date
2016-05-15

Primary Outcomes

Primary Outcomes (end points)
Primary:Port site incisional hernia
Secondary: bleeding,bile duct injury,reoperation,mortality
Primary Outcomes (explanation)
Primary end point of port site hernia is assessed clinically and by radiological method.
Secondary end points are assessed by clinical and radiological investigations

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Prospective,NHS based randomised clinical trial
Experimental Design Details
Prospective,NHS based randomised clinical trial
Randomization Method
Randomisation by computer
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
200
Sample size: planned number of observations
200
Sample size (or number of clusters) by treatment arms
100
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
p value <0.05 taken as significant
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan

Analysis Plan Documents

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials