Objective: To compare the incidence of delayed gastric emptying (ISGPS 2007 criteria) between patients undergoing retromesenteric versus transmesocolic reconstruction after pancreaticoduodenectomy. Secondary objectives include evaluating overall postoperative morbidity (Clavien-Dindo ≥ Grade I) at 90 days, postoperative pancreatic fistula according to ISGPF criteria, 30- and 90-day mortality, differences in operative time and blood loss, hospital stay duration, exploratory analysis of inflammatory biomarkers in serum and drainage fluid, psychological impact using SCL-90-R scale, and postoperative quality of life using EORTC QLQ-C30 scale.
Methods: Randomized, controlled, single-center superiority clinical trial with 1:1 allocation. One hundred twenty-four patients candidates for duodenopancreatectomy due to pancreatic pathology will be randomized using balanced blocks to transmesocolic (control) or retromesenteric (study) reconstruction. Randomization will be revealed after completing the resection phase. Primary intention-to-treat analysis will estimate relative risk with 95% CI for dichotomous variables, Kaplan-Meier survival analysis with log-rank test, and linear mixed models for repeated measures in quality of life outcomes. Follow-up will be 90 days for the primary endpoint, extending to 12 months for secondary objectives.
Age ≥ 18 years
Candidates for cephalic duodenopancreatectomy due to pancreatic pathology
Ability to complete follow-up questionnaires
Emergency surgery
Participation in another clinical trial
Pregnancy or lactation
Severe psychiatric disorder that prevents follow-up
Parallel
Retromesenteric reconstruction
Procedure/SurgeryPerform a retromesenteric reconstruction after pancreaticoduodenectomy
Transmesocolic reconstruction
Procedure/SurgeryPerform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy
Delayed Gastric Emptying
Delayed gastric emptying according to ISGPS 2007 definition: Grade A (nasogastric tube \>3 days or reinsertion between days 4-7 + vomiting); Grade B (tube \>7 days or reinsertion after day 7 + vomiting); Grade C (impossibility of oral tolerance after day 14)
Postoperative morbility
Postoperative morbidity at 90 days according to Clavien-Dindo classification (≥ Grade I)
Pancreatic fistula
Pancreatic fistula according to ISGPF 2016 definition: Grade A (drainage amylase \>3x normal on day 3 without clinical impact); Grade B (requiring management change); Grade C (reintervention or death)
Mortality
30- and 90-day mortality (any cause)
Hospital stay
Postoperative hospital stay days (from surgery to hospital discharge)
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