Laparoscopic Liver ResectionNCT06166511
Evaluation of Laparoscopic Non Anatomical Liver Resection in Hepatic Pathology
A study testing Laparoscopic liver resection in people with Laparoscopic Liver Resection, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Liver Resection
- What is being tested?
- Laparoscopic liver resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) any immunocompromised patient 2) Patient with contraindicdtions to use laparoscopy. 3) patient who are difficult to follow up.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assuit University hospitals
Asyut, Assuit
R S Ibrahim, Assist Prof, -005263686, ragaisobhy@hotmail.com
Mahmoud H Abd El rizk, Lecturer, -020871477, dr.hasaboo@gmail.com
About this study
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.
Read the 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:
- post operative pain 2) secondary bleeding and 3) wound infection.
Then follow up these patients in out patient clinic visit for their:
- satisfaction
- cosmetic outcomes and
- rate of recurrence of the pathology.
- Conditions
- Laparoscopic Liver Resection
- Being tested
- Laparoscopic liver resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic liver resectionProcedure or surgery
Using Laparoscopy in liver resection
| Study group | Role | What they receive |
|---|---|---|
| Group undergo laparoscopic liver resection | Experimental | Any patient from 18 to 65 and has localized liver pathology and underwent laparoscopic non anatomical resection of this pathology Receives: Procedure: Laparoscopic liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intra operative mortality
Number of cases die intra operative
Measured: 2 years
Length of operation
Time of operation
Measured: 2 years
Post operative pain
Pain scale post operative
Measured: 2 years
Incidence of intra operative complications
Type of complications and Its incidence
Measured: 2 years
Length of hospital stay
Time spended by cases in hospital
Measured: 2 years
Incidence of post operative complications
Type and incidence of post operative complications
Measured: 2 years
Secondary outcomes (2)
Cosmetic outcome
Patient cosmetic sutisfacton
Measured: 2 years
Incidence of recurrence of pathology
Number of cases with same pathology recurrence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start10 Jan 2024 (estimated)
- Primary completion10 Mar 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Liver ResectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Nasih Adly, Assiut University
- Investigators
- Nader N Adly, Principal investigator, Assuit University hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166511
- Sponsor's protocol ID
- Laparoscopic liver resection
- Status last verified
- Dec 2023
- First submitted
- 30 Oct 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31424576
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laparoscopic Non Anatomical Liver Resection in Hepatic Pathology
- ClinicalTrials.gov ID
- NCT06166511
- Acronym / sponsor ID
- Laparoscopic liver resection
- Conditions
- Laparoscopic Liver Resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (estimated)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- post operative pain 2) secondary bleeding and 3) wound infection.
Then follow up these patients in out patient clinic visit for their:
- satisfaction
- cosmetic outcomes and
- rate of recurrence of the pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group undergo laparoscopic liver resection | Experimental | Procedure: Laparoscopic liver resectionAny patient from 18 to 65 and has localized liver pathology and underwent laparoscopic non anatomical resection of this pathology |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) any immunocompromised patient 2) Patient with contraindicdtions to use laparoscopy. 3) patient who are difficult to follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic liver resectionUsing Laparoscopy in liver resection | Procedure or surgery | Group undergo laparoscopic liver resection |
Primary outcome
Incidence of intra operative mortality
Time frame: 2 years
Number of cases die intra operative
Length of operation
Time frame: 2 years
Time of operation
Post operative pain
Time frame: 2 years
Pain scale post operative
Incidence of intra operative complications
Time frame: 2 years
Type of complications and Its incidence
Length of hospital stay
Time frame: 2 years
Time spended by cases in hospital
Incidence of post operative complications
Time frame: 2 years
Type and incidence of post operative complications
2 secondary outcomes
Cosmetic outcome
Time frame: 2 years
Incidence of recurrence of pathology
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 31424576Garlipp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader N Adly principal investigator
Assuit University hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic liver resection in people with Laparoscopic Liver Resection, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact N N Adly (01206187141, nadernasihadly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intra operative mortality (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06166511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.