Late intestinal complications in minimally invasive total gastrectomy for gastric cancer
| ISRCTN | ISRCTN67352603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67352603 |
- Submission date
- 28/02/2024
- Registration date
- 19/03/2024
- Last edited
- 09/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Although minimally invasive total gastrectomy for gastric cancer is commonly performed, reports regarding late complications are limited. Since 2009, the study team made several improvements each time severe late complications were experienced. This study aims to evaluate the clinical efficacy of these improved procedures in preventing late complications.
Who can participate?
Patients who underwent laparoscopic or robotic total gastrectomy for gastric cancer between January 2009 and December 2019
What does the study involve?
The patients will be divided into two groups: Period-I (2009–2013, before established standardization of procedure) and Period-II (2014–2019, after established standardization of procedure). The procedure has been standardized through four major steps, typified by the closure of the mesentery and diaphragm crus, and fixation and linearization around the anastomotic site of esophagojejunostomy. The incidence of late complications will be retrospectively compared between the two groups.
What are the possible benefits and risks of participating?
There were no direct benefits for participating, but possibility to contribute to future advances in medical science. There were no risks of participating, due to no interventions required.
Where is the study run from?
Fujita Health University
When is the study starting and how long is it expected to run for?
August 2020 to August 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Susumu Shibasaki, susumushi48@mist.ocn.ne.jp
Contact information
Public, Scientific, Principal Investigator
1-98, Dengakugakubo, Kutsukake
Toyoake
470-1192
Japan
 ORCID ID |
0000-0003-2454-5083 |
|---|---|
| Phone | +81562939254 |
| susumushi48@mist.ocn.ne.jp |
Study information
| Study design | Single-center retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Medical and other records |
| Study type | Prevention, Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The risk factor of late intestinal complications in minimally invasive total gastrectomy for gastric cancer |
| Study hypothesis | The standardized procedures will prevent late intestinal complications by comparing two periods: before and after the establishment of standardization of the minimally invasive total gastrectomy procedure. |
| Ethics approval(s) |
Approved 29/08/2020, The Institutional Review Board of Fujita Health University (1-98, Dengakugakubo, Kutsukake, Toyoake, 470-1192, Japan; +81-562-93-2865; f-irb@fujita-hu.ac.jp), ref: HM23-318 |
| Condition | Prevention of late intestinal complications in patients who underwent minimally invasive total gastrectomy for gastric cancer. |
| Intervention | The procedure comprises four major steps, typified by the closure of the mesentery and diaphragm crus, and fixation and linearization around the anastomotic site of esophagojejunostomy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The incidence of complications within 3 years after surgery measured using data collected from medical records at one time point |
| Secondary outcome measures | The following secondary outcome variables will be measured using data collected from medical records at one time point: 1. Clinicopathological characteristics 2. Short-term surgical outcomes: 2.1. Operative time 2.2. Surgeon console time 2.3. Estimated blood loss 2.4. Number of dissected lymph nodes 2.5. Rates of local and systemic complications 2.6. Mortality rate 2.7. Length of postoperative hospitalization 2.8. Severity of reflux esophagitis at preoperative year (POY) 1 2.9. Body weight loss rate at POY 1 3. Long-term survival outcomes: 3.1. 3-year overall survival (OS) 3.2. 3-year relapse-free survival (RFS) |
| Overall study start date | 01/01/2020 |
| Overall study end date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 20 Years |
| Upper age limit | 91 Years |
| Sex | Both |
| Target number of participants | 302 |
| Total final enrolment | 302 |
| Participant inclusion criteria | 1. Patients between January 2009 and December 2019. 2. Patients underwent total gastrectomy for gastric cancer at our division. |
| Participant exclusion criteria | 1. Open gastrectomy 2. Clinical or pathological stage IV 3. Remnant gastric cancer 4. Palliative surgery 5. EGJ cancer 6. Observation period < 90 days 7. Use of circular stapler |
| Recruitment start date | 01/01/2021 |
| Recruitment end date | 31/12/2022 |
Locations
Countries of recruitment
- Japan
Study participating centre
Toyoake
470-1192
Japan
Sponsor information
University/education
Center for Clinical Trial and Research Support, 1-98, Dengakugakubo, Kutsukake
Toyoake
Aichi 470-1192
Japan
| Phone | +81-562-93-2884 |
|---|---|
| c-int-rl@fujita-hu.ac.jp | |
| Website | https://www.fujita-hu.ac.jp/ |
"ROR" |
https://ror.org/046f6cx68 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Susumu Shibasaki, susumu.shibasaki@fujita-hu.ac.jp. The data that support the findings of this study will be shared. All data were anonymized so consent from participants was not required or obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/06/2024 | 09/09/2024 | Yes | No |
Editorial Notes
09/09/2024: Publication reference added.
19/03/2024: Study's existence confirmed by the Office of Ethics Review Committee, Fujita Health University.
