|
ISRCTN
|
ISRCTN65426707
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The greater omental flap to cover the cut surface of the liver for prevention of delayed gastric emptying after left-sided hepatobiliary resection
|
|
Scientific title
|
The greater omental flap to cover the cut surface of the liver for prevention of delayed gastric emptying after left-sided hepatobiliary resection: a prospective randomised controlled trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
The use of the greater omental flap to cover the cut surface of the liver is effective in reducing the incidence of delayed gastric emptying (DGE) after left-sided hepatobiliary resection.
|
|
Lay summary
|
|
|
Ethics approval
|
The Human Research Review Committee of the Nagoya University Hospital approved on the 21st May 2007
|
|
Study design
|
Prospective randomised controlled trial
|
|
Countries of recruitment
|
Japan
|
|
Disease/condition/study domain
|
Delayed gastric emptying
|
|
Participants - inclusion criteria
|
Patients scheduled to undergo left-sided hepatobiliary resection for cholangiocarcinoma at the Nagoya University Hospital
|
|
Participants - exclusion criteria
|
1. Patients scheduled to undergo other gastrointestinal resection, including hepatopancreaticoduodenectomy
2. Previous gastrointestinal resection
3. Aged over 20 years, either sex
|
|
Anticipated start date
|
01/06/2007
|
|
Anticipated end date
|
31/12/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use contact details below to request a patient information sheet (in Japanese)
|
|
Target number of participants
|
40 patients
|
|
Interventions
|
Patients were randomised to undergo left-sided hepatobiliary resection
1. With greater omental flap to cover the cut surface of the liver
2. Without greater omental flap
|
|
Primary outcome measure(s)
|
Clinical grading of DGE based on the International Study Group of Pancreatic Surgery (ISGPS) classification. DGE was classified with regard to the duration of naso-gastric tube (NGT) requirement and/or need for re-insertion of NGT, and the postoperative day (POD) when solid food intake was tolerated after surgery. To assess DGE, once solid food intake was stablised, a radiopaque marker was administered. Abdominal X-rays were taken 1, 2, 3, 4, 5, and 6 hours after the administration of the marker.
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
Nagoya University Graduate School of Medicine (Japan) - Division of Surgical Oncology, Department of Surgery
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Tsuyoshi
Igami
|
|
Address
|
65, Tsurumai-cho, Showa-ku
|
|
City/town
|
Nagoya
|
|
Zip/Postcode
|
466-8550
|
|
Country
|
Japan
|
|
Email
|
igami@med.nagoya-u.ac.jp
|
|
Sponsor
|
Nagoya University Graduate School of Medicine (Japan) - Division of Surgical Oncology, Department of Surgery
|
|
Address
|
65, Tsurumai-cho,
Showa-ku
|
|
City/town
|
Nagoya
|
|
Zip/Postcode
|
466-8550
|
|
Country
|
Japan
|
|
Date applied
|
12/01/2010
|
|
Last edited
|
20/01/2010
|
|
Date ISRCTN assigned
|
19/01/2010
|
