Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial
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.
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Posted 10 Feb, 2021
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On 17 Dec, 2020
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On 17 Dec, 2020
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On 17 Dec, 2020
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On 25 Oct, 2020
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Received 16 Oct, 2020
Received 15 Oct, 2020
Invitations sent on 28 Sep, 2020
On 28 Sep, 2020
On 10 Sep, 2020
On 02 Sep, 2020
On 19 Jun, 2020
Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial
Posted 10 Feb, 2021
On 17 Feb, 2021
On 04 Feb, 2021
Received 01 Feb, 2021
On 31 Jan, 2021
Invitations sent on 31 Jan, 2021
On 31 Jan, 2021
On 31 Jan, 2021
On 14 Jan, 2021
Received 04 Jan, 2021
Received 20 Dec, 2020
On 17 Dec, 2020
On 17 Dec, 2020
On 17 Dec, 2020
Invitations sent on 17 Dec, 2020
On 17 Dec, 2020
Received 17 Dec, 2020
On 17 Dec, 2020
On 03 Nov, 2020
Received 02 Nov, 2020
On 25 Oct, 2020
On 16 Oct, 2020
Received 16 Oct, 2020
Received 15 Oct, 2020
Invitations sent on 28 Sep, 2020
On 28 Sep, 2020
On 10 Sep, 2020
On 02 Sep, 2020
On 19 Jun, 2020
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