Subcostal port and port site incisional hernia in cholecystectomy
Research type
Research Study
Full title
Subcostal port and port site incisional hernia in laparoscopic cholecystectomy
IRAS ID
245120
Contact name
ABDULZAHRA HUSSAIN
Contact email
Sponsor organisation
Doncaster and Bassetlaw Teaching Hospitals
ISRCTN Number
ISRCTN10569876
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
AEARCTR-0001121, https://www.socialscienceregistry.org; 0940/2018/NCTS, DBHT reference number
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The study is a randomised trial comparing two group of patients.In one group the gallbladder removal is conducted using the current technique.In the other group, the gallbladder is removed by a modification of the current technique.This modification is replacing one port of key-hole surgery with another one in a different location[ moving the port from mid-upper abdomen to the left upper abdomen].The study is testing whether the modification of the technique is resulting in fewer complications, mainly the hernia at the port site.All patients who are referred because of gall stone disease and considered eligible for gallbladder removal surgery are offered the choice of participation in this study.
The recruitment locations are the outpatient clinics at Doncaster and Bassetlaw Teaching Hospitals[Doncaster Royal Infirmary and Bassetlaw Hospitals] ,and the King's College Hospitals [Princess Royal University Hospital site].
The patients are randomised into two groups using online software[QuickCalcs (www.graphpad.com)].
250 patients are included [125 patients at each arm of the study].
The study is expected to take 36 months.
The study is registered at https://www.socialscienceregistry.org/trials/1121: REFERENCE:AEARCTR-0001121REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0150
Date of REC Opinion
24 Aug 2018
REC opinion
Further Information Favourable Opinion