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Gastric cancer ranks as the fifth most common and fifth most lethal cancer globally. For patients with AJCC stages IB to IIIC, representing the majority of cases, the current gold standard of surgical treatment involves total gastrectomy combined with D2 lymph node dissection, followed by gastrointestinal tract reconstruction .It has long been established that minimizing surgical intervention correlates with faster patient recovery. The Enhanced Recovery After Surgery (ERAS) guidelines provide globally recognized perioperative recommendations for a variety of surgical procedures, grounded in research, audits, and evidence-based practice. In 2014, Mortensen et al. introduced ERAS guidelines specifically tailored for gastrectomy in gastric cancer. These guidelines include both procedure-specific and general recommendations applicable to the perioperative management of abdominal surgeries.Since the publication of ERAS guidelines, evidence suggests limited and inconsistent global adherence to the protocol for gastrectomy, particularly regarding surgical drain use.Drains remain in use for gastrectomy, particularly in the East, where ongoing studies explore the prognostic value of drain contents post-gastrectomy without reaching consensus. Western adherence to ERAS recommendations on drains is similarly low.This prospective, non-randomized controlled clinical trial aims to assess the impact of one perianastomotic drain when it is placed under specific, predefined criteria. The trial evaluates the immediate and short-term postoperative outcomes in patients who underwent D2 total gastrectomy for gastric cancer which were performed in a high-volume centre and under the care of a highly experienced team
The DRAG (DRains After Gastrectomy) Trial is a prospective, non-randomized, controlled clinical trial involving patients diagnosed with gastric neoplasm. All surgeries were performed by a single, highly experienced surgeon in the 1st Propaedeutic Surgery Department at Hippocration General Hospital in Athens, Greece. The patients underwent open total gastrectomy with D2 lymph node dissection, followed by Roux-en-Y gastrointestinal tract reconstruction, in accordance with a predefined, ERAS-compliant perioperative departmental protocol. Our institution's protocol does not routinely incorporate exploratory laparoscopy or peritoneal cytology.
The participants were divided into two groups. The first group followed the department's standard practice, with a drain placed near the esophagojejunal anastomosis (drain group). In contrast, the second did not have a drain placed (non-drain group). The decision to place a drain was based on the following criteria:
The statistical analysis was performed using the R software (R foundation for Statistical Computing) version 4.3.0 for Windows. Descriptive characteristics for the quantitative data were expressed as median and Quartile 1 (Q1) to Quartile 3 (Q3) range and for completeness reasons the mean ± standard deviation (SD), for the qualitative data was reported the frequency of occurrence and the relevant percentage. Comparisons were preformed between patients with drainage and those without drainage; for the qualitative parameters statistical tests were performed via the chi-square test (and if required a Fisher exact test) and for the arithmetic data (as normality was not possible to be ensured using the Shapiro Wilk test), were applied not parametric tests, specifically the Mann Whitney U test. The significance level (p-value) was set to 0.05, thus statistically significant difference between compared groups was for p<0.05 and all tests were two sided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drain | No Intervention | The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice | |
| No drain | Experimental | The patients of this arm do not undergo perianastomotic drain placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No drain placement | Procedure | The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above |
| Measure | Description | Time Frame |
|---|---|---|
| a) Number of Participants With High Pain Levels (Using the Visual Analog Scale) | Postoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups: High pain: VAS score greater than 5 Not high pain: VAS score 5 or less This binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain. | Hospital stay, an average of 5 days |
| Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days | Postoperative nausea and vomiting (PONV) is considered an immediate effect of the perianastomotic drain. Measured as present or absent, with presence meaning worse results | Hospital stay, an average of 5 days |
| Number of Participants With Delay of Feeding Initiation | immediate outcome of perianastomic drain placement. Feeding is considered delayed if started after the 3rd day as per our protocol | Hospital stay, an average of 5 days |
| Number of Participants With Delay of Postoperative Mobilization | immediate postoperative effect of drain placement. Mobilization is considered delayed if the patient does not manage to achieve the milestones as per our(and ERAS)protocol. | Hospital stay, an average of 5 days |
| Length of Hospital Stay | immediate effect of drain placement | Hospital stay, an average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | short term effect of drain placement | 30 days |
| Surgically Related Readmissions | short term effect of drain placement | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitrios Theodorou, Professor | University of Athens | Study Chair |
| Maria-Malvina Eleftheriou, MD | Hippocration General Hospital of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hippocration General Hospital | Athens | 11527 | Greece |
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| ID | Title | Description |
|---|---|---|
| FG000 | Drain | The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice |
| FG001 | No Drain | The patients of this arm do not undergo perianastomotic drain placement. No drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Drain | The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice |
| BG001 | No Drain | The patients of this arm do not undergo perianastomotic drain placement. No drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | a) Number of Participants With High Pain Levels (Using the Visual Analog Scale) | Postoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups: High pain: VAS score greater than 5 Not high pain: VAS score 5 or less This binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain. | Posted | Count of Participants | Participants | Hospital stay, an average of 5 days |
|
30 days
1 adverse event:intraoperative pancreatic injury
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drain | The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pancreatic inlury | Surgical and medical procedures | Systematic Assessment | pancreatic injury/leak due to compression during lymph node dissection, detected 2 days later |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anastomotic leak | Surgical and medical procedures | Systematic Assessment | anastomotic leak |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maria Malvina Eleftheriou | 1st Propaedeutic Surgery Department,Hippocration Hospital,University of Athens, Greece | +30 6945176503 | malvina_el@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 | Feb 1, 2025 | Prot_SAP_000.pdf |
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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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| Day of Postoperative Bowel Mobilization | immediate effect of drain placement. If there is no mobilization of bowel (flatus or motion) within the first 3 days, it is considered delay of the bowel movement | Hospital stay approx 5 days |
| Reoperations | short term effect of drain placement | 30 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Drain | The patients of this arm do not undergo perianastomotic drain placement. No drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above |
|
|
| Primary | Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days | Postoperative nausea and vomiting (PONV) is considered an immediate effect of the perianastomotic drain. Measured as present or absent, with presence meaning worse results | Posted | Count of Participants | Participants | Hospital stay, an average of 5 days |
|
|
|
| Primary | Number of Participants With Delay of Feeding Initiation | immediate outcome of perianastomic drain placement. Feeding is considered delayed if started after the 3rd day as per our protocol | Posted | Count of Participants | Participants | Hospital stay, an average of 5 days |
|
|
|
| Primary | Number of Participants With Delay of Postoperative Mobilization | immediate postoperative effect of drain placement. Mobilization is considered delayed if the patient does not manage to achieve the milestones as per our(and ERAS)protocol. | Posted | Count of Participants | Participants | Hospital stay, an average of 5 days |
|
|
|
| Primary | Length of Hospital Stay | immediate effect of drain placement | Posted | Median | Inter-Quartile Range | days | Hospital stay, an average of 5 days |
|
|
|
| Primary | Day of Postoperative Bowel Mobilization | immediate effect of drain placement. If there is no mobilization of bowel (flatus or motion) within the first 3 days, it is considered delay of the bowel movement | Posted | Median | Full Range | days | Hospital stay approx 5 days |
|
|
|
| Secondary | Mortality | short term effect of drain placement | Posted | Count of Participants | Participants | 30 days |
|
|
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| Secondary | Surgically Related Readmissions | short term effect of drain placement | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Reoperations | short term effect of drain placement | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 1 |
| 40 |
| 0 |
| 40 |
| 4 |
| 40 |
| EG001 | No Drain | The patients of this arm do not undergo perianastomotic drain placement. No drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above | 2 | 20 | 1 | 20 | 2 | 20 |
|
| postoperative bleeding | Surgical and medical procedures | Systematic Assessment | Postoperative bleeding |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |