NCT02789826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

3.5 years

First QC Date

May 22, 2016

Last Update Submit

September 6, 2020

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Mortality

    30 days post-operative

  • Postoperative complications

    Postoperatively with follow-up to one year

  • Peri-operative blood loss

    during surgery, 1 day

  • Duration of Surgery

    Peri-operatively, 1 day

Study Arms (2)

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.

Procedure: Laparoscopic gastrectomy

Open gastrectomy

ACTIVE COMPARATOR

Patients allocated to the 'Open Gastrectomy' group will receive gastrectomy via laparotomy. This group is considered the control group

Procedure: Open gastrectomy

Interventions

Laparoscopic gastrectomyPROCEDURE

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

Also known as: Minimally invasive gastrectomy
Laparoscopic gastrectomy
Open gastrectomyPROCEDURE

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

Open gastrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Laparoscopic gastric cancer resection
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 22, 2016

First Posted

June 3, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)