GastrectomyNCT06758934
Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer
An observational study of Gastrectomy and Gastric Cancer, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Gastric cancer patients underwent total gastrectomy with curative intent between in a single center were included in this retrospective study. Patients divided to two groups as open and laparoscopic groups and compared in terms of demographic data, tumor characteristics, operative data and textbook outcome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrectomy, Gastric Cancer
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastric cancer patients ≥ 18 years old and underwent total gastrectomy with curative intent
Who may be able to join
- Gastric cancer patients underwent total gastrectomy with curative intent
Who cannot join
- Emergency surgery,
- Recurrent disease
- Metastatic disease,
- Conversion to open surgery,
- Robotic gastrectomy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Gastric cancer patients underwent total gastrectomy with curative intent between in a single center were included in this retrospective study. Patients divided to two groups as open and laparoscopic groups and compared in terms of demographic data, tumor characteristics, operative data and textbook outcome
Read the detailed description
Gastric cancer patients underwent total gastrectomy with curative intent between July 2018 and January 2024 in a single center were included in this retrospective observational study. Enrolled patients divided to two groups as open total gastrectomy (open group) and laparoscopic total gastrectomy (lap group).
Data of patients obtained via the hospital software system. Demographic data, body mass index(BMI), Charlson comorbidity index (CCI) score and baseline characteristics, operative and postoperative results, tumor characteristics and textbook outcome results were investigated. Postoperative complications were pancreatic fistula, pleural effusion, pneumonia, anastomotic leak, intraabdominal abscess, surgical site infection, postoperative ileus.
All patients were already curative surgery patients and underwent total gastrectomy and D2 lymphadenectomy. Apart from this, the list of criteria for a patient who had a textbook outcome was as follows: no intraoperative complication, achievement of tumor-negative margins, including ≥15 harvested lymph nodes in resected specimen, no severe postoperative complication(Clavien-Dindo Score≥3, (CD)), no reintervention, no readmission to intensive care unit after once coming to the surgical ward, no prolonged hospital stay (≤21 days), no postoperative mortality (30 days) and no readmission after discharge from the hospital
- Conditions
- Gastrectomy, Gastric Cancer
- Keywords
- Total Gastrectomy, Textbook Outcome, Open Gastrectomy, Minimally Invasive Surgery
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open Group | Gastric cancer patients underwent open total gastrectomy with curative intent between July 2018 and January 2024 | |
| Lap Group | Gastric cancer patients underwent laparoscopic total gastrectomy with curative intent between July 2018 and January 2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Textbook Outcome
The criteria required for a patient who underwent total gastrectomy to have reached a textbook outcome are as follows:
- no intraoperative complication,
- achievement of tumor-negative margin,
- including ≥15 harvested lymph nodes in resected specimen,
- no severe postoperative complication(Clavien-Dindo Score≥3, (CD)),
- no reintervention,
- no readmission to intensive care unit after once coming to the surgical ward,
- no prolonged hospital stay (≤21 days),
- no postoperative mortality (30 days) and
- no readmission after discharge from the hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Aug 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Turgut Donmez, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Alpen Yahya Gümüşoğlu, Ass. Prof. Dr., Study chair, University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758934
- Sponsor's protocol ID
- 20240213
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analysed during the current study are not available due to institutional policies but are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT06758934
- Acronym / sponsor ID
- 20240213
- Conditions
- Gastrectomy, Gastric Cancer
- Keywords
- Total Gastrectomy, Textbook Outcome, Open Gastrectomy, Minimally Invasive Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric cancer patients underwent total gastrectomy with curative intent between in a single center were included in this retrospective study. Patients divided to two groups as open and laparoscopic groups and compared in terms of demographic data, tumor characteristics, operative data and textbook outcome
Detailed description
Gastric cancer patients underwent total gastrectomy with curative intent between July 2018 and January 2024 in a single center were included in this retrospective observational study. Enrolled patients divided to two groups as open total gastrectomy (open group) and laparoscopic total gastrectomy (lap group).
Data of patients obtained via the hospital software system. Demographic data, body mass index(BMI), Charlson comorbidity index (CCI) score and baseline characteristics, operative and postoperative results, tumor characteristics and textbook outcome results were investigated. Postoperative complications were pancreatic fistula, pleural effusion, pneumonia, anastomotic leak, intraabdominal abscess, surgical site infection, postoperative ileus.
All patients were already curative surgery patients and underwent total gastrectomy and D2 lymphadenectomy. Apart from this, the list of criteria for a patient who had a textbook outcome was as follows: no intraoperative complication, achievement of tumor-negative margins, including ≥15 harvested lymph nodes in resected specimen, no severe postoperative complication(Clavien-Dindo Score≥3, (CD)), no reintervention, no readmission to intensive care unit after once coming to the surgical ward, no prolonged hospital stay (≤21 days), no postoperative mortality (30 days) and no readmission after discharge from the hospital
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Group | – | –Gastric cancer patients underwent open total gastrectomy with curative intent between July 2018 and January 2024 |
| Lap Group | – | –Gastric cancer patients underwent laparoscopic total gastrectomy with curative intent between July 2018 and January 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastric cancer patients ≥ 18 years old and underwent total gastrectomy with curative intent
Key inclusion criteria (1 listed)
- Gastric cancer patients underwent total gastrectomy with curative intent
Key exclusion criteria (5 listed)
- Emergency surgery,
- Recurrent disease
- Metastatic disease,
- Conversion to open surgery,
- Robotic gastrectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Textbook Outcome
Time frame: 30 days
The criteria required for a patient who underwent total gastrectomy to have reached a textbook outcome are as follows: * no intraoperative complication, * achievement of tumor-negative margin, * including ≥15 harvested lymph nodes in resected specimen, * no severe postoperative complication(Clavien-Dindo Score≥3, (CD)), * no reintervention, * no readmission to intensive care unit after once coming to the surgical ward, * no prolonged hospital stay (≤21 days), * no postoperative mortality (30 days) and * no readmission after discharge from the hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No. The datasets generated and analysed during the current study are not available due to institutional policies but are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpen Yahya Gümüşoğlu, Ass. Prof. Dr. study chair
University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrectomy and Gastric Cancer, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Textbook Outcome (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.