Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center

• Sponsor: Services Hospital, Lahore (Other)
• Overall Status: Completed
• CT.gov ID: NCT03820583
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Actual Duration (Months): 60
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple procedure were studied by compiling demographic details of the patients, common presenting symptoms, various indications for Whipple's procedure, the cofactors which affect the procedures outcome and morbidity and mortality of the patients.

Condition or Disease	Intervention/Treatment	Phase
Whipple Procedure	Procedure: Whipple Procedure	N/A

Detailed Description

This study was performed by collecting data through predesigned questionnaire about patients undergoing Whipple's procedure from operation theatres and medical record section. Those patients, whose tumor was unresectable and undergone palliative surgical procedures were excluded from the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients undergoing Whipple procedure due to pancreatic tumor were included in the studyPatients undergoing Whipple procedure due to pancreatic tumor were included in the study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Outcome Measures

Primary Outcome Measures

1. Percentage of patients developing pancreatic fistula [4 weeks]

   Percentage of patients developing pancreatic fistula (pancreatic juice collected in drain rich in amylase) after Whipple procedure Enteric leak postoperative complications like pancreatic fistula, anastomotic leakage, hemorrhage, wound infection,mortality

2. Percentage of patients developing hemorrhage [2 weeks]

   Percentage of patients developing hemorrhage after Whipple procedure

3. Percentage of patients developing wound infection [4 weeks]

   Percentage of patients developing wound infection after Whipple procedure

4. Mortality rate [6 weeks]

   Mortality of patients undergoing Whipple surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients of both sexes with age ranging from 20 years to 70 years

• patients with pancreatic tumors

• patients with adequate cardiorespiratory reserves to be fit for prolong general anesthesia

Exclusion Criteria:

• unresectable tumors

• unfit for surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Services hospital	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

• Services Hospital, Lahore

Investigators

• Study Director: Mahmmood Ayyaz, mbbs, fcps, Services Hospital, Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. SamiUllah, Principle investigator, Services Hospital, Lahore
• ClinicalTrials.gov Identifier: NCT03820583
• Other Study ID Numbers: s11
• First Posted: Jan 29, 2019
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. SamiUllah, Principle investigator, Services Hospital, Lahore: Whipple procedure, pancreatic carcinoma, biliary stenting,

Study Results

No Results Posted as of Jan 31, 2019