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The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).
There are two main types of techniques (open & laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is superior in early postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open resection (less safety margin & less lymphadenectomy) but because of the ongoing advances on laparoscopic surgery these results needs more and more revision.
So the investigators conduct this randomized controlled trial aiming at comparing open and laparoscopic resection of cancer stomach to choose the best surgical procedure for resection of cancer stomach.
The surgical procedure for resection of cancer stomach aiming at resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).
# Tumor resection;
Will be done by one of the following techniques:
laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour)
Open gastrectomy (according to the site of tumor). # Lymphadenectomy; Will be done according to Japanese Gastric Cancer Association guidelines for optimal lymph node dissection levels for Early Gastric Cancer (1):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic gastrectomy | Experimental | Patients allocated to the 'laparoscopic Gastrectomy' group will undergo laparoscopic gastrectomy. If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one. |
|
| Open gastrectomy | Active Comparator | Patients allocated to the 'Open Gastrectomy' group will receive gastrectomy via laparotomy. This group is considered the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic gastrectomy | Procedure | Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of lymph nodes in the postoperative spicement. | considered a prognostic factor for disease-free postoperative survival The more the number of lymph nodes the more radicality of the procesure | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Measured as 30-day mortality rate | 30 days post-operative |
| Postoperative complications | Complications will be graded according to the Clavien-Dindo classification, which grades complications with regard to necessary treatment for this complication. Also Long-term complications, such as hernia cicatricialis will be monitored |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mostafa A Hamad, Prof. | Assiut University- Faculty of Medicine | Study Director |
| Mostafa M Sayed | Assiut University- Faculty of Medicine | Study Director |
| Mohamed G Taher | Assiut University- Faculty of Medicine- General surgery department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospitals | Asyut | Egypt |
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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 gastric cancer resection
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| Open gastrectomy | Procedure | patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy |
|
| Postoperatively with follow-up to one year |
| Peri-operative blood loss | Laparoscopic gastrectomy is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and compared to the conventional 'open' group. | during surgery, 1 day |
| Duration of Surgery | UsuallyLaparoscopic gastrectomy takes longer time to complete. The duration of the procedure will be registered in minutes. | Peri-operatively, 1 day |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |