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 |
| Protocol serial number | N/A |
| Sponsor | Nagoya University Graduate School of Medicine (Japan) - Division of Surgical Oncology, Department of Surgery |
| Funder | Nagoya University Graduate School of Medicine (Japan) - Division of Surgical Oncology, Department of Surgery |
- 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
Scientific
65, Tsurumai-cho, Showa-ku
Nagoya
466-8550
Japan
| igami@med.nagoya-u.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| 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
466-8550
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
