The greater omental flap to cover the cut surface of the liver for prevention of delayed gastric emptying after left-sided hepatobiliary resection

ISRCTN	ISRCTN65426707
DOI	https://doi.org/10.1186/ISRCTN65426707
Secondary identifying numbers	N/A

Submission date: 12/01/2010
Registration date: 19/01/2010
Last edited: 20/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tsuyoshi Igami
Scientific

65, Tsurumai-cho, Showa-ku
Nagoya
466-8550
Japan

Email	igami@med.nagoya-u.ac.jp

Study information

Study design	Prospective randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet (in Japanese)
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
Study objectives	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.
Ethics approval(s)	The Human Research Review Committee of the Nagoya University Hospital approved on the 21st May 2007
Health condition(s) or problem(s) studied	Delayed gastric emptying
Intervention	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
Intervention type	Procedure/Surgery
Primary outcome measure	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 measures	No secondary outcome measures
Overall study start date	01/06/2007
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 patients
Key inclusion criteria	Patients scheduled to undergo left-sided hepatobiliary resection for cholangiocarcinoma at the Nagoya University Hospital
Key exclusion criteria	1. Patients scheduled to undergo other gastrointestinal resection, including hepatopancreaticoduodenectomy 2. Previous gastrointestinal resection 3. Aged over 20 years, either sex
Date of first enrolment	01/06/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Japan

Study participating centre

65, Tsurumai-cho, Showa-ku

Nagoya
466-8550
Japan

Sponsor information

Nagoya University Graduate School of Medicine (Japan) - Division of Surgical Oncology, Department of Surgery
University/education

65, Tsurumai-cho
Showa-ku
Nagoya
466-8550
Japan

"ROR"	https://ror.org/00ndx3g44

Funders

Funder type

University/education

Nagoya University Graduate School of Medicine (Japan) - Division of Surgical Oncology, Department of Surgery

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan