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Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT

NCT05192044 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-01-14

No results posted yet for this study

Summary

Few decades back pancreatico-duodenectomy (PD) was associated with a very high morbidity and mortality. With recent advancements in surgical and anesthetic techniques and improvement in peri-operative care, PD has evolved into a procedure with acceptable morbidity and mortality. Today PD is associated with a mortality of less than 5%, in high volume tertiary care centers. The multimodal concept of fast-track surgery was first introduced in colonic surgery. Several studies have demonstrated the effectiveness of this program in colonic resection. Recently, fast-track surgery has been attempted in pancreatic surgery with encouraging results, but such data are sparse. The core aims of ERAS protocols are to safely hasten postoperative recovery and ease the stress response.

Specifically, in the context of pancreatico-duodenectomy, such interventions have been shown to be safe with no increase in mortality or unplanned readmissions, delayed gastric emptying (DGE), or pancreatic fistula . Purported benefits include reduced admission related costs, incidence of DGE, overall morbidity and length of stay.

The aim of this study was to evaluate the feasibility of implementing fast track rehabilitation protocol following pancreaticoduodenectomy and to see if it is associated with improved recovery, reduced morbidity and reduced length of hospital stay.

Conditions

  • Pancreas Cancer

Interventions

OTHER

Fast track Care pancreatico-duodenectomy.

Enhanced recovery after pancreatico-duodenectomy, with early oral intake, mobilization \& discharge

OTHER

Conventional Care

Conventional Care

Sponsors & Collaborators

  • National Cancer Institute, Egypt

    lead OTHER

Principal Investigators

  • Ahmed M Mahmoud, Professor · National Cancer Institute, Cairo University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-25
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05192044 on ClinicalTrials.gov