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

NCT ID: NCT05192044

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-25
• Study Completion Date: 2023-07-01

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).

Conditions

Pancreas Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Fast track Care (Enhanced recovery after)pancreatico-duodenectomy

Group Type: EXPERIMENTAL

Fast track Care pancreatico-duodenectomy.

Intervention Type: OTHER

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

Group B

Conventional Care pancreatico-duodenectomy.

Group Type: ACTIVE_COMPARATOR

Conventional Care

Intervention Type: OTHER

Conventional Care

Interventions

Fast track Care pancreatico-duodenectomy.

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

Intervention Type: OTHER

Conventional Care

Conventional Care

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed M Mahmoud, Professor

Role: STUDY_DIRECTOR

National Cancer Institute, Cairo University, Egypt

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yasser A Debakey, Lecturer

Role: CONTACT

y.eldebakey@cu.edu.eg

01001340579 ext. +2

Ahmed M Mahmoud, Professor

Role: CONTACT

drbarbary@yahoo.com

01001729571 ext. +2

Facility Contacts

Ahmed M Mahmoud, Professor

Role: primary

drbarbary@yahoo.com

01001729571 ext. +2

Other Identifiers

Debakey4

Identifier Type: -

Identifier Source: org_study_id