See the published version of this article at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial
Valentina Mengardo
Universita degli Studi di Verona
Corresponding Author
ORCiD: https://orcid.org/0000-0002-5915-1028
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the Authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015 only retrospective studies have been published, all with inconsistent results.
Methods: ADiGe (Abdominal Drain in GastrEctomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment.
The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, readmission rate.
Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to patient and caregivers.
Discussion: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.
Trial registration: Prospectively registered (last updated on October 29, 2020) at Clinicaltrials.gov with the identifier NCT04227951, https://clinicaltrials.gov/ct2/show/NCT04227951.
Keywords
Gastric cancer, Gastrectomy, Abdominal drain, Drainage, Randomised controlled trial
Figure 1
Figure 2
Figure 3
Figure 4
This is a list of supplementary files associated with this preprint. Click to download.
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 3
Posted 10 Feb, 2021
Published
On 17 Feb, 2021
No community comments so far
Editorial decision: Accept
On 04 Feb, 2021
Review #1 received
Received 01 Feb, 2021
Editor assigned
On 31 Jan, 2021
Reviewers invited
Invitations sent on 31 Jan, 2021
Reviewer #1 agreed
On 31 Jan, 2021
Submission checks complete
On 31 Jan, 2021
No comments provided
Editorial decision: Minor revision
On 14 Jan, 2021
Review #3 received
Received 04 Jan, 2021
Review #1 received
Received 20 Dec, 2020
Reviewer #2 agreed
On 17 Dec, 2020
Reviewer #3 agreed
On 17 Dec, 2020
Editor assigned
On 17 Dec, 2020
Reviewers invited
Invitations sent on 17 Dec, 2020
Reviewer #1 agreed
On 17 Dec, 2020
Review #2 received
Received 17 Dec, 2020
Submission checks complete
On 17 Dec, 2020
No comments provided
Editorial decision: Major revision
On 03 Nov, 2020
Review #3 received
Received 02 Nov, 2020
Reviewer #3 agreed
On 25 Oct, 2020
Reviewer #2 agreed
On 16 Oct, 2020
Review #2 received
Received 16 Oct, 2020
Review #1 received
Received 15 Oct, 2020
Reviewers invited
Invitations sent on 28 Sep, 2020
Reviewer #1 agreed
On 28 Sep, 2020
Editor assigned
On 10 Sep, 2020
Submission checks complete
On 02 Sep, 2020
First submitted
On 19 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Gastrointestinal Surgery
Learn more about our company.
This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial
Valentina Mengardo
Universita degli Studi di Verona
Corresponding Author
ORCiD: https://orcid.org/0000-0002-5915-1028
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 3
Posted 10 Feb, 2021
Published
On 17 Feb, 2021
No community comments so far
Editorial decision: Accept
On 04 Feb, 2021
Review #1 received
Received 01 Feb, 2021
Editor assigned
On 31 Jan, 2021
Reviewers invited
Invitations sent on 31 Jan, 2021
Reviewer #1 agreed
On 31 Jan, 2021
Submission checks complete
On 31 Jan, 2021
No comments provided
Editorial decision: Minor revision
On 14 Jan, 2021
Review #3 received
Received 04 Jan, 2021
Review #1 received
Received 20 Dec, 2020
Reviewer #2 agreed
On 17 Dec, 2020
Reviewer #3 agreed
On 17 Dec, 2020
Editor assigned
On 17 Dec, 2020
Reviewers invited
Invitations sent on 17 Dec, 2020
Reviewer #1 agreed
On 17 Dec, 2020
Review #2 received
Received 17 Dec, 2020
Submission checks complete
On 17 Dec, 2020
No comments provided
Editorial decision: Major revision
On 03 Nov, 2020
Review #3 received
Received 02 Nov, 2020
Reviewer #3 agreed
On 25 Oct, 2020
Reviewer #2 agreed
On 16 Oct, 2020
Review #2 received
Received 16 Oct, 2020
Review #1 received
Received 15 Oct, 2020
Reviewers invited
Invitations sent on 28 Sep, 2020
Reviewer #1 agreed
On 28 Sep, 2020
Editor assigned
On 10 Sep, 2020
Submission checks complete
On 02 Sep, 2020
First submitted
On 19 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Gastrointestinal Surgery
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the Authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015 only retrospective studies have been published, all with inconsistent results.
Methods: ADiGe (Abdominal Drain in GastrEctomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment.
The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, readmission rate.
Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to patient and caregivers.
Discussion: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.
Trial registration: Prospectively registered (last updated on October 29, 2020) at Clinicaltrials.gov with the identifier NCT04227951, https://clinicaltrials.gov/ct2/show/NCT04227951.
Figure 1
Figure 2
Figure 3
Figure 4