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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Johnson & Johnson | INDUSTRY |
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This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take three and five years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Gastrectomy | Active Comparator | Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group |
|
| Laparoscopic Gastrectomy | Experimental | Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Gastrectomy | Procedure | Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative hospital stay | The primary outcome of this study is the post-operative hospital stay (days), since this is considered a strong end point as it reflects the impact of the different surgical procedures. | During admission, an expected average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Measured as 30-day mortality rate | 30 days post-operative |
| Post-operative morbidity | Complications will be classified according to the Clavien-Dindo system and include anastomotic leakage, anastomotic stricture, respiratory complications, cardiac complications, intra-abdominal bleeding , intra-abdominal abscess, sepsis, ileus, wound infection, fistula, urinary tract infection and dumping syndrome |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative blood loss | Measured in milliliters (ml) | Post-operative day 1 |
| Operative time | The time from incision to closure of all wounds in minutes (min) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard van Hillegersberg, MD PhD | Dept. of Surgery, University Medical Center Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zorggroep Twente Almelo | Almelo | Netherlands | ||||
| Meander Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26219670 | Background | Haverkamp L, Brenkman HJ, Seesing MF, Gisbertz SS, van Berge Henegouwen MI, Luyer MD, Nieuwenhuijzen GA, Wijnhoven BP, van Lanschot JJ, de Steur WO, Hartgrink HH, Stoot JH, Hulsewe KW, Spillenaar Bilgen EJ, Rutter JE, Kouwenhoven EA, van Det MJ, van der Peet DL, Daams F, Draaisma WA, Broeders IA, van Stel HF, Lacle MM, Ruurda JP, van Hillegersberg R; LOGICA study group. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial). BMC Cancer. 2015 Jul 29;15:556. doi: 10.1186/s12885-015-1551-z. | |
| 37464143 |
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Individual participant data that underlie the results reported in the primary manuscript will be shared after de-identification (text, tables, figures, and appendices).
Immediately following publication; no end date.
Anyone who wishes to access the data for any purpose.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Laparoscopic Gastrectomy | Procedure | Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy. |
|
| Up to 5 years post-operative |
| Cost-effectiveness | Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies up until five years after the operation | Up to 5 years post-operative |
| Quality of Life | The validated quality of life questionnaires EORTC QLQ-30, EORTC QLQ-STO22 and EQ-5D-5L, will be filled in pre-operative <5 days and post-operative at 6 weeks, 12, 24, 36, 48 and 60 months after surgery. | Up to 5 years post-operative |
| Readmissions | The number of post-operative readmissions | Up to 5 years post-operative |
| Oncologic outcomes (R0-resection rate and lymph node yield) | R0-resection rate of the distal and proximal margin, defined according to the College of American Pathologists. Lymph node yield: the amount of harvested lymph nodes per patient. | Pathology report 1-2 weeks after surgery |
| Post-operative day 1 |
| Conversion rate | The percentage (%) of laparoscopic gastrectomies that had to be converted intra-operatively to an open procedure due to any reason. | Post-operative day 1 |
| Survival | Measured as 5-year disease free survival and 5-year overall survival | Up to 5 years post-operative |
| VAS-score | Post-operative day 1 and 2 |
| Surgeons ergonomics | Measured with the Subjective Mental Effort Questionnaire (SMEQ) | Post-operative day 1 |
| Time to return to normal nutritional regime | Up to 5 years post-operative |
| Time to return to daily activity | Up to 5 years post-operative |
| Amersfoort |
| Netherlands |
| VU University Medical Center | Amsterdam | 1081 HZ | Netherlands |
| Academic Medical Center | Amsterdam | 1105 AZ | Netherlands |
| Gelre Hospital | Apeldoorn | Netherlands |
| Catharina Hospital | Eindhoven | 5623 EJ | Netherlands |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015 CE | Netherlands |
| Zuyderland Medical Center | Sittard-Geleen | 6162 BG | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| Derived |
| van der Veen A, Ramaekers M, Marsman M, Brenkman HJF, Seesing MFJ, Luyer MDP, Nieuwenhuijzen GAP, Stoot JHMB, Tegels JJW, Wijnhoven BPL, de Steur WO, Kouwenhoven EA, Wassenaar EB, Draaisma WA, Gisbertz SS, van der Peet DL, May AM, Ruurda JP, van Hillegersberg R; LOGICA study group. Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial). J Gastrointest Surg. 2023 Oct;27(10):2057-2067. doi: 10.1007/s11605-023-05728-3. Epub 2023 Jul 18. |
| 37340107 | Derived | de Jongh C, van der Veen A, Brosens LAA, Nieuwenhuijzen GAP, Stoot JHMB, Ruurda JP, van Hillegersberg R; LOGICA Study Group. Distal Versus Total D2-Gastrectomy for Gastric Cancer: a Secondary Analysis of Surgical and Oncological Outcomes Including Quality of Life in the Multicenter Randomized LOGICA-Trial. J Gastrointest Surg. 2023 Sep;27(9):1812-1824. doi: 10.1007/s11605-023-05683-z. Epub 2023 Jun 20. |
| 34581617 | Derived | van der Veen A, Brenkman HJF, Seesing MFJ, Haverkamp L, Luyer MDP, Nieuwenhuijzen GAP, Stoot JHMB, Tegels JJW, Wijnhoven BPL, Lagarde SM, de Steur WO, Hartgrink HH, Kouwenhoven EA, Wassenaar EB, Draaisma WA, Gisbertz SS, van der Peet DL, May AM, Ruurda JP, van Hillegersberg R; LOGICA Study Group. Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial. J Clin Oncol. 2021 Mar 20;39(9):978-989. doi: 10.1200/JCO.20.01540. Epub 2021 Jan 6. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |