ClinicalTrials.gg
Status unknownNCT04107909Updated Sep 27, 2019

Laparoscopic Cholecystectomy:

An interventional study of laparoscopic cholecystectomy in Cholecystitis, sponsored by Assiut University. Status unknown. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by Assiut University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

Various modifications have been tried in laparoscopic cholecystectomy since its introduction. One, two and three port LC have been performed on limited scale. we aim to compare three port LC with four port LC in patients with cholelithiasis. The main objective of this study is to evaluate the outcome of 3 ports LC for treatment of cholelithiasis by comparing the result with 4 ports LC with respect to safety and efficacy.

Read the detailed description

Various modifications have been tried in laparoscopic cholecystectomy since its introduction. One, two and three port LC have been performed on limited scale. we aim was to compare three port LC with four port LC in patients with cholelithiasis. The main objective of this study was to evaluate the outcome of 3 ports LC for treatment of cholelithiasis by comparing the result with 4 To study the efficacy and feasibility of 3 port and 4 port lap cholecystetctomy.

1. To compare the intraoperative and post-operative complications of 3 port and 4 port lap cholecystectomy

  1. Operative time,
  2. Days of hospital stay.
  3. complication
  4. post-operative pain ports LC with respect to safety and efficacy.
02

Conditions studied

  • Cholecystitis

Browse trials for

03

In context

Cholecystitis

272 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's planned enrollment of 100 is above the median of 87 across 172 interventional studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age of patient between 25 and 65 years
  2. Diagnosis of chronic cholecystitis, symptomatic cholelithiasis

Exclusion criteria

Exclusion Criteria:

  1. Choledocholithiasis
  2. Severe Acute Calculus Pancreatitis
  3. Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia) 4 . Previous operation or adhesion
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Other
    3 ports

    3port operation

    Procedure: laparoscopic cholecystectomy

  • Other
    4 port

    4 port operation

    Procedure: laparoscopic cholecystectomy

Interventions

  • Procedurelaparoscopic cholecystectomy

    Both four port and three port LC is performed With the patient in supine position, with the surgeon and assistant on the left side and the monitor on the right side. Head up and right up position is employed during surgery in both the groups. Pneumoperitoneum of 12mmHg is created using open Hassan's method through the umbilical port. In 3 port a 5.5 mm umbilical visiport for 5 mm lens 30 degree A second 10 mm trocar is placed inferior to the sternum at the midline, while the third 5mm trocar is placed 4-5cm inferior to the right costal margin on the right midclavicular line. For the four port LC, additional 5mm port is placed in the sub costal region at the anterior axillary line. Posterior dissection and delineation of The Calot's triangle is done. Then, the cystic artery and cystic duct are identified, isolated, doubly clipped and divided. The gallbladder is removed through the umbilical port using a 10mm gallbladder extractor.

06

What researchers measure

Primary outcomes

  1. compare between the prognosis of three port and four port laproscpic cholecyctectomy

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Muhe E. [Laparoscopic cholecystectomy--late results]. Langenbecks Arch Chir Suppl Kongressbd. 1991:416-23. doi: 10.1007/978-3-642-95662-1_189. German. PubMed 1838946 ↗
  • Traverso LW. Carl Langenbuch and the first cholecystectomy. Am J Surg. 1976 Jul;132(1):81-2. doi: 10.1016/0002-9610(76)90295-6. PubMed 782269 ↗
  • Trichak S. Three-port vs standard four-port laparoscopic cholecystectomy. Surg Endosc. 2003 Sep;17(9):1434-6. doi: 10.1007/s00464-002-8713-1. Epub 2003 Jun 13. PubMed 12799892 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2019; primary completion for Dec 2022, 36 months later.

Of 79 non-industry interventional studies with no phase under Cholecystitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's planned 36 months is above that.

Counting every sponsor, half of 85 studies reached it within 18 months; a quarter within 9 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2019
First posted
Sep 27, 2019
StartEst.
Dec 30, 2019
Primary completionEst.
Dec 30, 2022
CompletionEst.
Dec 20, 2023
Last update
Sep 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04107909
Lead sponsor
Assiut University
Responsible party
Mohamed Ali Abdelfatah Elshreef (general surgery, Assiut University) — Principal investigator
First posted
Sep 27, 2019
Start date
Dec 30, 2019 (estimated)
Primary completion
Dec 30, 2022 (estimated)
Completion
Dec 20, 2023 (estimated)
Last update
Sep 27, 2019

Study contacts

mohammed ali
Contact
mahamedelshreef1993@hotmail.com
002101020832073

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion