ClinicalTrials.gg
CompletedNCT03477253Updated Apr 28, 2021

Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

An interventional study of Laparoscopic cholecystectomy in Acute Calculous Cholecystitis, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-28.

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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Cholecystitis, Acute with a site in Egypt — none open to participants now, none under way, none of them phase 3. Cholecystitis, Acute · Egypt.

Enrollment
9th of 10
62 · median 147
Started
2017
with 1 other
No phase
9 of 10
none open now
Registered
2nd of 10
by date
Lead sponsor
1 of 10
Assiut University

Among the 10 studies in Cholecystitis, Acute with a site in Egypt, this one is the 9th largest by enrollment, is one of 2 that started in 2017, is one of 9 with no phase, and was the 2nd registered.

Cholecystitis, Acute

140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.

Browse Cholecystitis, Acute studies →

Open to participants now

None of the 10 studies in Cholecystitis, Acute with a site in Egypt is open now.

Who these studies take

Of the 20 Cholecystitis, Acute studies recruiting now, 16 (80%) set no upper age limit and 2 (10%) stop at 75 or younger; 2 take children under 18; 0 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Download CSVNarrow it in search →With an account: the 10 studies in Cholecystitis, Acute with a site in Egypt as a file.
02

Study summary

This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.

Read the detailed description

The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.

This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A \& B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.

03

Conditions studied

  • Acute Calculous Cholecystitis

Browse trials for

Keywords

  • Acute calculous cholecystitis
  • Laparoscopic cholecystectomy
  • Early laparoscopic cholecystectomy
  • Late laparoscopic cholecystectomy
04

Who can participate

Ages eligible
18 Years to 70 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. Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count > 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
  2. Initial surgical management planned for immediate laparoscopic cholecystectomy.
  3. Patients who are fit for laparoscopy and general anesthesia.
  4. Patient who agree to provide short term outcome data and agree to provide contact information.

Exclusion criteria

Exclusion Criteria:

  1. Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
  2. Patients with other associated abdominal pathology.
  3. Patients with any previous abdominal surgery or any significant systemic disease.
  4. Septic shock.
  5. Pregnancy/ Breast-feeding mothers.
  6. Participation in an additional drug or device study and inability to offer .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    LC within 72 hours of disease onset

    Immediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients

    Procedure: Laparoscopic cholecystectomy

  • Active comparator
    LC after 72 hours of disease onset

    Late laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients

    Procedure: Laparoscopic cholecystectomy

Interventions

  • ProcedureLaparoscopic cholecystectomy

    The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits

06

What researchers measure

Primary outcomes

  1. Comparison between early and late laparoscopic cholecystectomy regarding Operation time

    comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes

    Time frame: intra-operative

  2. Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation

    comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy

    Time frame: intra-operative

  3. comparison between early and late laparoscopic cholecystectomy regarding post operative pain

    comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics

    Time frame: within 1month post operative

  4. Duration of postoperative hospital stay

    comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital

    Time frame: within 2 weeks post-operative

Secondary outcomes

  1. comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage

    compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of bile leakage

    Time frame: first 72 hours post-operative

  2. comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding

    compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of postoperative bleeding

    Time frame: 7 days postoperative

  3. presence of any wound complication by examining the wound

    comparison between early and late laparoscopic cholecystectomy concerning the presence and rate of wound infection by clinical examination post-operative

    Time frame: within 10 days post-operative

07

Study locations

1 site
  • Assiut University
    Assiut, Egypt
08

References and documents

Publications

  • Yuval JB, Mizrahi I, Mazeh H, Weiss DJ, Almogy G, Bala M, Kuchuk E, Siam B, Simanovsky N, Eid A, Pikarsky AJ. Delayed Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis: Is it Time for a Change? World J Surg. 2017 Jul;41(7):1762-1768. doi: 10.1007/s00268-017-3928-4. PubMed 28251270 ↗
  • Gomes CA, Junior CS, Di Saverio S, Sartelli M, Kelly MD, Gomes CC, Gomes FC, Correa LD, Alves CB, Guimaraes SF. Acute calculous cholecystitis: Review of current best practices. World J Gastrointest Surg. 2017 May 27;9(5):118-126. doi: 10.4240/wjgs.v9.i5.118. Erratum In: World J Gastrointest Surg. 2017 Oct 27;9(10):214. doi: 10.4240/wjgs.v9.i10.214. PubMed 28603584 ↗
  • Terho PM, Leppaniemi AK, Mentula PJ. Laparoscopic cholecystectomy for acute calculous cholecystitis: a retrospective study assessing risk factors for conversion and complications. World J Emerg Surg. 2016 Nov 16;11:54. doi: 10.1186/s13017-016-0111-4. eCollection 2016. PubMed 27891173 ↗
  • Bagla P, Sarria JC, Riall TS. Management of acute cholecystitis. Curr Opin Infect Dis. 2016 Oct;29(5):508-13. doi: 10.1097/QCO.0000000000000297. PubMed 27429137 ↗
  • Dudchenko MO, Kravtsiv MI, Lyulka MO, Lyakhovsky VI, Furman DD, Bondar LD. [TREATMENT OF ACUTE CALCULOUS CHOLECYSTITIS: "EARLY" OR "PLANNED" LAPAROSCOPIC CHOLECYSTECTMIVY]. Klin Khir. 2015 Jun;(6):19-21. Ukrainian. PubMed 26521459 ↗
  • Polo M, Duclos A, Polazzi S, Payet C, Lifante JC, Cotte E, Barth X, Glehen O, Passot G. Acute Cholecystitis-Optimal Timing for Early Cholecystectomy: a French Nationwide Study. J Gastrointest Surg. 2015 Nov;19(11):2003-10. doi: 10.1007/s11605-015-2909-x. Epub 2015 Aug 12. PubMed 26264362 ↗
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

Ran from Oct 2017 to primary completion in Jan 2020, 27 months.

Of 42 non-industry interventional studies with no phase under Cholecystitis, Acute, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 27 months is above that.

Counting every sponsor, half of 45 studies reached it within 20 months; a quarter within 9 and three quarters within 27.

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

Registered
Mar 14, 2018
First posted
Mar 26, 2018
StartActual
Oct 1, 2017
Primary completionActual
Jan 1, 2020
CompletionActual
Apr 1, 2020
Last update
Apr 28, 2021
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 Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477253
Lead sponsor
Assiut University
Responsible party
Mohamed Elmahdy Ali Abdel Rahman Morsy (Resident Doctor, Assiut University) — Principal investigator
First posted
Mar 26, 2018
Start date
Oct 1, 2017
Primary completion
Jan 1, 2020
Completion
Apr 1, 2020
Last update
Apr 28, 2021

Study contacts

Mohamed Elmahdy
study chair · Assiut University
Gamal Abdel Hameed
study director · Assiut University
Gamal Makhlouf
principal investigator · Assiut University

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2021. 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