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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06166511
Other study ID # Laparoscopic liver resection
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 10, 2024
Est. completion date May 10, 2025

Study information

Verified date December 2023
Source Assiut University
Contact N N Adly
Phone 01206187141
Email nadernasihadly@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 10, 2025
Est. primary completion date March 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic liver resection
Using Laparoscopy in liver resection

Locations

Country Name City State
Egypt Assuit University hospitals Assiut Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of intra operative mortality Number of cases die intra operative 2 years
Primary Length of operation Time of operation 2 years
Primary Post operative pain Pain scale post operative 2 years
Primary Incidence of intra operative complications Type of complications and Its incidence 2 years
Primary Length of hospital stay Time spended by cases in hospital 2 years
Primary Incidence of post operative complications Type and incidence of post operative complications 2 years
Secondary Cosmetic outcome Patient cosmetic sutisfacton 2 years
Secondary Incidence of recurrence of pathology Number of cases with same pathology recurrence 2 years
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