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OpenTrials
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NCT Number: NCT02789826

Laparoscopic Versus Open Resection of Cancer Stomach

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university hospitals

Asyut, Egypt

About this study

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):
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1-3, N0-1, M0).

Exclusion criteria

  • Pregnancy.
  • Infiltration to the( pancreas ,liver ,colon or vital vascular structure).
  • Metastasis to the (liver, lung, brain, paraaortic LN involvement).
  • Peritoneal deposit.
  • Surgically unfit patient.

Treatment and study plan

Laparoscopic Gastrectomy

Procedure

Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy.

Other names: Minimally invasive gastrectomy

Open gastrectomy

Procedure

patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy

Primary outcomes

  1. The number of lymph nodes in the postoperative spicement.

    Time frame: two weeks

    considered a prognostic factor for disease-free postoperative survival The more the number of lymph nodes the more radicality of the procesure

Secondary outcomes

  1. Mortality

    Time frame: 30 days post-operative

    Measured as 30-day mortality rate

  2. Postoperative complications

    Time frame: Postoperatively with follow-up to one year

    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

  3. Peri-operative blood loss

    Time frame: during surgery, 1 day

    Laparoscopic gastrectomy is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and compared to the conventional 'open' group.

  4. Duration of Surgery

    Time frame: Peri-operatively, 1 day

    UsuallyLaparoscopic gastrectomy takes longer time to complete. The duration of the procedure will be registered in minutes.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 3, 2016
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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