Trial Outcomes & Findings for Perianastomotic Drain After Gastrectomy (DRAG) (NCT NCT04288661)
NCT ID: NCT04288661
Last Updated: 2025-04-27
Results Overview
Postoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups: High pain: VAS score greater than 5 Not high pain: VAS score 5 or less This binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Hospital stay, an average of 5 days
Results posted on
2025-04-27
Participant Flow
Participant milestones
| Measure |
Drain
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
40
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perianastomotic Drain After Gastrectomy (DRAG)
Baseline characteristics by cohort
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.5 years
n=99 Participants
|
73 years
n=107 Participants
|
73 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
40 participants
n=99 Participants
|
20 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Hospital stay, an average of 5 daysPostoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups: High pain: VAS score greater than 5 Not high pain: VAS score 5 or less This binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain.
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
a) Number of Participants With High Pain Levels (Using the Visual Analog Scale)
|
31 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Hospital stay, an average of 5 daysPostoperative nausea and vomiting (PONV) is considered an immediate effect of the perianastomotic drain. Measured as present or absent, with presence meaning worse results
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days
|
24 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Hospital stay, an average of 5 daysimmediate outcome of perianastomic drain placement. Feeding is considered delayed if started after the 3rd day as per our protocol
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Number of Participants With Delay of Feeding Initiation
|
15 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Hospital stay, an average of 5 daysimmediate postoperative effect of drain placement. Mobilization is considered delayed if the patient does not manage to achieve the milestones as per our(and ERAS)protocol.
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Number of Participants With Delay of Postoperative Mobilization
|
20 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Hospital stay, an average of 5 daysimmediate effect of drain placement
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Length of Hospital Stay
|
7 days
Interval 6.0 to 10.0
|
5 days
Interval 5.0 to 6.0
|
PRIMARY outcome
Timeframe: Hospital stay approx 5 daysimmediate effect of drain placement. If there is no mobilization of bowel (flatus or motion) within the first 3 days, it is considered delay of the bowel movement
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Day of Postoperative Bowel Mobilization
|
4 days
Interval 3.0 to 4.0
|
3 days
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 30 daysshort term effect of drain placement
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Mortality
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysshort term effect of drain placement
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Surgically Related Readmissions
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysshort term effect of drain placement
Outcome measures
| Measure |
Drain
n=40 Participants
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 Participants
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Reoperations
|
4 Participants
|
2 Participants
|
Adverse Events
Drain
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
No Drain
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Drain
n=40 participants at risk
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 participants at risk
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Surgical and medical procedures
pancreatic inlury
|
0.00%
0/40 • 30 days
1 adverse event:intraoperative pancreatic injury
|
5.0%
1/20 • Number of events 1 • 30 days
1 adverse event:intraoperative pancreatic injury
|
Other adverse events
| Measure |
Drain
n=40 participants at risk
The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
|
No Drain
n=20 participants at risk
The patients of this arm do not undergo perianastomotic drain placement.
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, according to the criteria stated above
|
|---|---|---|
|
Surgical and medical procedures
anastomotic leak
|
10.0%
4/40 • Number of events 4 • 30 days
1 adverse event:intraoperative pancreatic injury
|
10.0%
2/20 • Number of events 2 • 30 days
1 adverse event:intraoperative pancreatic injury
|
|
Surgical and medical procedures
postoperative bleeding
|
7.5%
3/40 • Number of events 3 • 30 days
1 adverse event:intraoperative pancreatic injury
|
0.00%
0/20 • 30 days
1 adverse event:intraoperative pancreatic injury
|
Additional Information
Dr Maria Malvina Eleftheriou
1st Propaedeutic Surgery Department,Hippocration Hospital,University of Athens, Greece
Phone: +30 6945176503
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place