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Esophageal cancer is a debilitating condition. The treatment involved is complex requiring a combination of chemotherapy and surgery in most cases. Complete removal of the tumor and the adjacent lymph nodes is of utmost importance in improving the survival. Lymph node yield following surgery helps in proper staging of the disease and is an important prognosticating variable. It is hypothesized that the lymph node yield following robotic esophagectomy is higher than that following thoracolaparoscopic esophagectomy. The study aims to compare the short term oncological outcomes following robotic esophagectomy and thoracolaparoscopic esophagectomy for carcinoma esophagus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic esophagectomy | Experimental | Esophagectomy performed for esophageal cancer using the da Vinci robotic surgical system |
|
| Thoracolaparoscopic esophagectomy | Active Comparator | Esophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic esophagectomy | Procedure | Removal of the esophagus and its draining lymph nodes using robotic surgical instruments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lymph node yield | Total number of lymph nodes harvested | 7 days after Index Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical margin status | The proximal, distal and circumferential surgical margins will be assessed by pathological evaluation for the presence of tumor and will be assigned an "R" category as defined by the College of American Pathologists. R0 would indicate no evidence of residual tumor. Presence of microscopic tumor at margins would be designated as R1 whereas the presence of macroscopically visible tumor at margins would be designated as R2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shankar Balasubramanian | Contact | +919910766534 | shanxar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chinnusamy Palanivelu, MS, MCh | GEM Hospital & Research Center | Principal Investigator |
| Shankar Balasubramanian, MS, MRCS | GEM Hospital & Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GEM Hospital & Research Center | Recruiting | Chennai | Tamil Nadu | India |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Thoracolaparoscopic esophagectomy | Procedure | Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques |
|
| 7 days after Index Surgery |
| Complications | Intraoperative and post operative adverse events assessed by Clavien Dindo classification system | Up to 90 days after surgery |
| ICU stay | Duration of stay in ICU following surgery | During index admission or within 30 days after surgery |
| Hospital stay | Length of stay in hospital following surgery | During index admission or re admission within 30 days |
| Mortality | Death following surgery | During index admission or within 90 days following surgery |
| Duration of surgery | Time taken to complete the surgical procedure recorded in minutes | 1 day after surgery |
| Blood loss | Amount of blood lost during and within 24 hours of surgery | During surgery and up to 24 hours after index surgery |
| Conversion rate | Need for conversion of the procedure to open or other alternate technique | 1 day after surgery |
| Sandeep Sabnis, MS, DNB |
| GEM Hospital & Research Center |
| Study Director |
| GEM Hospital & Research Center | Recruiting | Coimbatore | Tamil Nadu | 641045 | India |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |