Clinical trial NCT06166511: Evaluation of Laparoscopic Non Anatomical Liver Resection in Hepatic Pathology
Official title: Evaluation of Laparoscopic Non Anatomical Liver Resection in Hepatic Pathology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laparoscopic Liver Resection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of intra operative mortality
timeFrame: 2 years
measure: Length of operation
timeFrame: 2 years
measure: Post operative pain
timeFrame: 2 years
measure: Incidence of intra operative complications
timeFrame: 2 years
measure: Length of hospital stay
timeFrame: 2 years
measure: Incidence of post operative complications
timeFrame: 2 years
Secondary outcomes:
measure: Cosmetic outcome
timeFrame: 2 years
measure: Incidence of recurrence of pathology
timeFrame: 2 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University hospitals
state: Assuit
Study officials:
affiliation: Assuit University hospitals
name: Nader N Adly
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.