Condition category
Surgery
Date applied
12/01/2010
Date assigned
19/01/2010
Last edited
20/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tsuyoshi Igami

ORCID ID

Contact details

65
Tsurumai-cho
Showa-ku
Nagoya
466-8550
Japan
igami@med.nagoya-u.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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.

Ethics approval

The Human Research Review Committee of the Nagoya University Hospital approved on the 21st May 2007

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet (in Japanese)

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients scheduled to undergo left-sided hepatobiliary resection for cholangiocarcinoma at the Nagoya University Hospital

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients

Participant exclusion criteria

1. Patients scheduled to undergo other gastrointestinal resection, including hepatopancreaticoduodenectomy
2. Previous gastrointestinal resection
3. Aged over 20 years, either sex

Recruitment start date

01/06/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Japan

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes