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Spots Global Cancer Trial Database for Laparoscopic Versus Open Resection of Cancer Stomach

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Trial Identification

Brief Title: Laparoscopic Versus Open Resection of Cancer Stomach

Official Title: Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial

Study ID: NCT02789826

Conditions

Gastric Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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: 1. laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour) 2. 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): * D1+alpha -(perigastric lymph node dissection) for mucosal cancer, for which EMR is not indicated and for histologically differentiated submucosal cancer of \< 1.5 cm in diameter; * D1+ beta for preoperatively diagnosed submucosal cancer without lymph node metastasis (N0), for which D1+ alpha is not indicated, and for early cancer \< 2.0 cm in diameter with only perigastric lymph node metastasis (N1); * D2 for early cancer \> 2.0 cm in diameter. Follow up: all patients will be followed up clinically for the outcomes for each surgical technique.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Assiut university hospitals, Assiut, , Egypt

Contact Details

Name: Mostafa A Hamad, Prof.

Affiliation: Assiut University- Faculty of Medicine

Role: STUDY_DIRECTOR

Name: Mostafa M Sayed

Affiliation: Assiut University- Faculty of Medicine

Role: STUDY_DIRECTOR

Name: Mohamed G Taher

Affiliation: Assiut University- Faculty of Medicine- General surgery department

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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