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

Primary Purpose

Pancreas Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fast track Care pancreatico-duodenectomy.
Conventional Care
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≤ 75 years
  • ASA 1 or 2
  • BMI < 35
  • The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study

Exclusion Criteria:

- pancreatico-duodenectomy with vascular reconstruction.

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Fast track Care (Enhanced recovery after)pancreatico-duodenectomy

Conventional Care pancreatico-duodenectomy.

Outcomes

Primary Outcome Measures

Feasibility of enhanced recovery after pancreatico-dudenectomy
Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification

Secondary Outcome Measures

Full Information

First Posted
December 30, 2021
Last Updated
January 13, 2022
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05192044
Brief Title
Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT
Official Title
Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Study population: This is a prospective study that will be conducted on all patients of both sexes and definite age groups attending the National Cancer Institute, Cairo University and candidate for pancreatico-duodenectomy Sampling: all cases fulfilling the inclusion criteria will be included in the study. Patients will be classified into two groups: Group A: Fast track Care pancreatico-duodenectomy. Group B: Conventional Care pancreatico-duodenectomy. Baseline demographics, body mass index (BMI), perioperative parameters, postoperative course, postoperative complications and 30-days operative mortality will be analyzed. Inclusion criteria: Age ≤ 75 years ASA 1 or 2 BMI < 35 The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study Exclusion criteria: pancreatico-duodenectomy with vascular reconstruction. Unenthusiastic patients. Type of study: randomized controlled trial The assignment of patients to either group will be done by a random computer-assissted allocation. The allocation will be done by the use of opaque envelopes with assignments. It's an open-labeled study i.e. patients, investigators (surgeons, researchers) and data collectors will know which procedure will be done to which patients. Discharge criteria for goup A include; uncomplicated procedure, afebrile patient without tachycardia, tolerance of oral feeding, adequate control of pain with oral analgesia, patient ambulating independently, adequate support at home. Follow up: will be completed within one month (immediate post-operative outcome).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Fast track Care (Enhanced recovery after)pancreatico-duodenectomy
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Conventional Care pancreatico-duodenectomy.
Intervention Type
Other
Intervention Name(s)
Fast track Care pancreatico-duodenectomy.
Intervention Description
Enhanced recovery after pancreatico-duodenectomy, with early oral intake, mobilization & discharge
Intervention Type
Other
Intervention Name(s)
Conventional Care
Intervention Description
Conventional Care
Primary Outcome Measure Information:
Title
Feasibility of enhanced recovery after pancreatico-dudenectomy
Description
Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification
Time Frame
1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≤ 75 years ASA 1 or 2 BMI < 35 The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study Exclusion Criteria: - pancreatico-duodenectomy with vascular reconstruction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser A Debakey, Lecturer
Phone
01001340579
Ext
+2
Email
y.eldebakey@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Mahmoud, Professor
Phone
01001729571
Ext
+2
Email
drbarbary@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Mahmoud, Professor
Organizational Affiliation
National Cancer Institute, Cairo University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Mahmoud, Professor
Phone
01001729571
Ext
+2
Email
drbarbary@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In a publication
IPD Sharing Time Frame
After publication & for a year
IPD Sharing Access Criteria
The journal of publication

Learn more about this trial

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

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