Perianastomotic Drain After Gastrectomy (DRAG) (DRAG)

  • STATUS
    Recruiting
  • End date
    Jun 25, 2024
  • participants needed
    66
  • sponsor
    THEODOROU DIMITRIOS
Updated on 25 April 2022
gastrectomy
lymphadenectomy
esophageal cancer
d2 lymph node dissection

Summary

The placement of an abdominal drain consists one of the most controversial issues not only after gastrectomy, but also after any abdominal operation in general. During the past decades drains have been widely used after major abdominal operations. Nevertheless, following the latest perioperative management trends, not all surgeons seem to embrace the idea. There are still many new studies or in progress, mainly in the East, examining the prognostic value of the drain content after a gastrectomy. Thus, the use of a drain is still under question. The aim of the present study is to evaluate whether the placement of a perianastomotic drain after total gastrectomy with D2 lymphadenectomy contributes to the early diagnosis of intraabdominal complications such as bleeding, abscess, anastomotic leak or pancreatic fistula. The participants will be patients with pathologically confirmed gastric or gastroesophageal junction (GEJ) cancer, and will undergo total gastrectomy plus D2 lymph node dissection and Roux-en-Y gastrointestinal tract reconstruction.

Description

This is a prospective randomized controlled trial that will be conducted in the 1st Propaedeutic Department of Surgery of National and Kapodistrian University of Athens. Sixty six patients suffering from histologically confirmed gastric or gastroesophageal junction cancer will be included in the study. They will be treated with a typical total gastrectomy plus D2 lymph node dissection and Roux-en-Y gastrointestinal tract reconstruction, under a predefined perioperative protocol, which complies with the ERAS guidelines. All patients will have to sign a study specific consent form and will be educated to the perioperative protocol prior to the operation. The randomization will take place right before the abdominal wall closure, and the participants will be divided in two groups: the intervention group (without perianastomotic drain) and the control group (placement of a suction drain close to the esophagojejunal anastomosis). In the control group, the drain will be removed as usual on the fifth postoperative day only if the below criteria are satisfied: a)less than 100cc of drainage for two consecutive days and b) no clinical suspicion of anastomotic leak and/or bleeding and/or intraabdominal abscess and/or pancreatic fistula. The participants' preoperative and intraoperative data will be meticulously recorded. The postoperative course of all patients will be closely monitored and any clinical, laboratory or imaging suspicion of the above mentioned complications will be evaluated and managed as per institutional standard of care. The subjects will be followed up on postoperative days ten, thirty and sixty through clinical examination, laboratory tests and, if needed, imaging exams. The primary outcome of this trial will be the postoperative day on which a Clavien-Dindo II-IV complication will be detected. The secondary outcome measures will include length of stay, morbidity and mortality, drain- related morbidity, postoperative pain evaluation, quality of life after the operation and readmissions.

Details
Condition Gastric Cancer
Treatment No drain placement
Clinical Study IdentifierNCT04288661
SponsorTHEODOROU DIMITRIOS
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age more than or equal to 18 years
Histologically proven gastric or gastro-esophageal cancer
Patients that undergo open total D2 gastrectomy with Roux-en-Y reconstruction
ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1
Curative resection
Signed informed consent form

Exclusion Criteria

Metastatic disease
Additional resections needed
Ascites
Cachexia
Concurrent participation in other study(ies)
Concurrent diagnosis of mental illness
Lack of perioperative protocol compliance
Pregnancy
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