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

NCT05192044 | Unknown

• 1 other identifier: Debakey4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Feasibility of enhanced recovery after pancreatico-dudenectomy

  Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification

  1 month after surgery

Study Arms (2)

Group A

EXPERIMENTAL

Fast track Care (Enhanced recovery after)pancreatico-duodenectomy

Other: Fast track Care pancreatico-duodenectomy.

Group B

ACTIVE COMPARATOR

Conventional Care pancreatico-duodenectomy.

Other: Conventional Care

Interventions

Fast track Care pancreatico-duodenectomy. OTHER

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

Group A

Conventional Care OTHER

Conventional Care

Group B

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≤ 75 years
• ASA 1 or 2
• BMI \< 35

You may not qualify if:

• \- pancreatico-duodenectomy with vascular reconstruction.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ahmed M Mahmoud, Professor

  National Cancer Institute, Cairo University, Egypt

  STUDY DIRECTOR

Central Study Contacts

Yasser A Debakey, Lecturer

CONTACT

01001340579; y.eldebakey@cu.edu.eg

Ahmed M Mahmoud, Professor

CONTACT

01001729571; drbarbary@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 14, 2022
• Study Start: December 25, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication \& for a year
• Access Criteria: The journal of publication

Locations

EG (1)