Evaluation of Laparoscopic Non Anatomical Liver Resection in Hepatic Pathology

Laparoscopy is a type of surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without making large incisions in the skin.The use of laparoscopy in abdomenal surgeries increases for its great benefits over open surgery as:

1)faster recovery, 2)decrease blood loss, 3)shorter hospital stays, 4)decreased postoperative pain, 5)earlier return to work and resumption of normal daily activity as well as, 6)cosmetic benefits.

few studies discuss the efficacy and safety of using Laparoscopy in liver non anatomical resection.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Liver Resection
• Intervention / Treatment: Procedure: Laparoscopic liver resection

Detailed Description

this study will include any male and female above 18 that presented with localized liver pathology (as benign hepatic tumours, resectable primary(HCC) or secondary malignancies, hydatid cyst any other hepatic cysts, haemangiomas,etc…...) and underwent laparoscopic non anatomical resection of liver in Assiut university hospitals. Investigators will record the time of operation, number of cases with intra operative mortality or complication and then follow up these patients during time of hospital stay for:

1) post operative pain 2) secondary bleeding and 3) wound infection.

Then follow up these patients in out patient clinic visit for their:

1. satisfaction
2. cosmetic outcomes and
3. rate of recurrence of the pathology.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: N N Adly; Phone Number: 01206187141; Email: nadernasihadly@gmail.com
• Study Contact Backup: Name: Abd El-moniem I El-khateeb, Prof; Phone Number: 01005022533; Email: Profalelhateeb@gmail.com

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt
      • Assuit University hospitals
      • Contact: R S Ibrahim, Assist Prof; Phone Number: -005263686; Email: ragaisobhy@hotmail.com
      • Contact: Mahmoud H Abd El rizk, Lecturer; Phone Number: -020871477; Email: dr.hasaboo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• any male or female above 18 that has one of the following pathologies and underwent non anatomical hepatic resection:
• hepatic benign tumours as adenoma
• resectable secondary malignancies (2)
• any type of hepatic cysts e.g., hydatid cyst
• HCC on top of liver cirrhosis.

Exclusion Criteria:

• 1) any immunocompromised patient 2) Patient with contraindicdtions to use laparoscopy. 3) patient who are difficult to follow up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group undergo laparoscopic liver resection; Any patient from 18 to 65 and has localized liver pathology and underwent laparoscopic non anatomical resection of this pathology	Procedure: Laparoscopic liver resection; Using Laparoscopy in liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intra operative mortality	Number of cases die intra operative	2 years
Length of operation	Time of operation	2 years
Post operative pain	Pain scale post operative	2 years
Incidence of intra operative complications	Type of complications and Its incidence	2 years
Length of hospital stay	Time spended by cases in hospital	2 years
Incidence of post operative complications	Type and incidence of post operative complications	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic outcome	Patient cosmetic sutisfacton	2 years
Incidence of recurrence of pathology	Number of cases with same pathology recurrence	2 years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Nader N Adly, Assuit University hospitals

Publications and helpful links

General Publications

• Garlipp B, Gibbs P, Van Hazel GA, Jeyarajah R, Martin RCG, Bruns CJ, Lang H, Manas DM, Ettorre GM, Pardo F, Donckier V, Benckert C, van Gulik TM, Goere D, Schoen M, Pratschke J, Bechstein WO, de la Cuesta AM, Adeyemi S, Ricke J, Seidensticker M. Secondary technical resectability of colorectal cancer liver metastases after chemotherapy with or without selective internal radiotherapy in the randomized SIRFLOX trial. Br J Surg. 2019 Dec;106(13):1837-1846. doi: 10.1002/bjs.11283. Epub 2019 Aug 19.

Study record dates

Study Major Dates

• Study Start (Estimated): January 10, 2024
• Primary Completion (Estimated): March 10, 2025
• Study Completion (Estimated): May 10, 2025

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Laparoscopic liver resection

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No