Perianastomotic Drain After Gastrectomy (DRAG)

Gastric Cancer Clinical Trial

— DRAG  

Official title:

Assessment of Abdominal Perianastomotic Drain Placement After Open Gastrectomy for Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288661
• Other study ID #: 1678 / 31-01-2020
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: June 2024

Study information

• Verified date: March 2022
• Source: University of Athens
• Contact: Maria-Malvina Eleftheriou, MD
• Phone: 2132088142
• Email: malvina_el[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• No drain placement
The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered

Locations

Country	Name	City	State
Greece	Hippocration General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
THEODOROU DIMITRIOS

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POD of intra-abdominal complication detection	Post-operative day of class II-IV intra-abdominal complication detection	Hospital stay, an average of 7 days
Secondary	Hospital stay	Hospital stay (in days)	Hospital stay, an average of 7 days
Secondary	Mortality	Mortality	60 post-operative days
Secondary	Morbidity	Total Morbidity	60 post-operative days
Secondary	Drain related morbidity	Drain related morbidity	60 post-operative days
Secondary	Post-operative pain: visual analogue scale (VAS) score	Post-operative pain assessment with visual analogue scale (VAS) score	60 post-operative days
Secondary	Quality of life before and after gastrectomy: questionnaire assessment	Quality of life questionnaire assessment	60 post-operative days
Secondary	Readmissions	Readmission rate	60 post-operative days