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Clinical Trials/NCT06281379
NCT06281379CompletedNot Applicable

Short-term Results of a Randomized Controlled Trial and Review of the Literature Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer: Short-term Results of a Randomized Controlled Trial and Review of the Literature

Başakşehir Çam & Sakura City Hospital1 site in 1 country37 target enrollmentStarted: April 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
37
Locations
1
Primary Endpoint
Postoperative outcome

Study Overview

Brief Summary

Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.

Study design:Randomised-controlled study

Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.

Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.

Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization.

Detailed Description

The curative treatment of gastrointestinal tumors is surgery referring to an en block resection of the primary tumor along with its lymphovascular drainage.Unfortunately, despite of these radical resections, published literature shows that recurrences occur in up to 38% of patients in 5 years. Morover, these rates may reach to 60% in patients with locally advanced tumor following radical surgery. However, this mesentery-based surgery is harder to apply in gastric cancer due to differences in embriyological development. In our prospective study and a review of the literature, following the descripiton of mesogastrium concept, we aimed to search and analyse former techniques and viewpoints about mesogastric excision by different surgical approaches from various countries. Later, we aimed to show our technique of mesogastrectomy, compared our short term results with limited publications from the literature.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with histopathologically confirmed gastric adenocancer without evidence of distal metastasis and resectable tumors which have been treated with open total gastrectomy.

Exclusion Criteria

  • •Patients with prior upper gastrointestinal system surgery
  • •Patients with neoadjuvant therapy
  • •Patients with peripheral organ involvement and/or distant metastasis
  • •Patients who underwent subtotal gastrectomy
  • •Patients who underwent laparoscopic and robotic operations

Arms & Interventions

Group 1

Experimental

Total gastrectomy+mesogastrectomy

Intervention: Total mesogastrectomy (Procedure)

Group 2

Other

Total gastrectomy with concentional D2 lymphadenectomy

Intervention: Total mesogastrectomy (Procedure)

Outcomes

Primary Outcomes

Postoperative outcome

Time Frame: Postoperative 1 week

Complications

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Başakşehir Çam & Sakura City Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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