NCT06166511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

October 30, 2023

Last Update Submit

December 3, 2023

Conditions

Laparoscopic Liver Resection

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Cosmetic outcome

    2 years

  • Incidence of recurrence of pathology

    2 years

Study Arms (1)

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

Procedure: Laparoscopic liver resection

Interventions

Laparoscopic liver resectionPROCEDURE

Using Laparoscopy in liver resection

Group undergo laparoscopic liver resection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University hospitals

Asyut, Assuit, Egypt

Location

Related 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.

    PMID: 31424576BACKGROUND

Study Officials

  • Nader N Adly

    Assuit University hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

N N Adly

CONTACT

01206187141nadernasihadly@gmail.com

Abd El-moniem I El-khateeb, Prof

CONTACT

01005022533Profalelhateeb@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resedent doctor

Study Record Dates

First Submitted

October 30, 2023

First Posted

December 12, 2023

Study Start

January 10, 2024

Primary Completion

March 10, 2025

Study Completion

May 10, 2025

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

EG(1)