Acute CholecystitisNCT02130245
Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
A study testing Early cholecystectomy and Delayed cholecystectomy in people with Acute Cholecystitis, run by Mansoura University at 1 site in Egypt.
Trial summary
The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The hypothesis is that to do it as an early intervention after patient admission is better than delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Early cholecystectomy and Delayed cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2013to Jan 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Proved acute cholecystitis clinical, radiologic
Who cannot join
- Evidence of peritonitis
- ASA III or IV
- Previous upper abdominal surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
mansoura university hospital, EGYPT, central hafr elbatin hospital, Saudia Arabia
Al Mansurah
mohamed E abd ellatif, PhD, 00966543973660, SURG_LATIF@HOTMAIL.COM
MOHAMED E ABD ELLATIF, PHD
About this study
The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The hypothesis is that to do it as an early intervention after patient admission is better than delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.
Read the detailed description
Doing laparoscopic cholecystectomy for patients with acute cholecystitis as an early intervention after patient admission ( first group) or to do it after a while of treatment and conservation as a delayed cholecystectomy (second group) points of study include the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.
- Conditions
- Acute Cholecystitis
- Being tested
- Early cholecystectomy, Delayed cholecystectomy
- Keywords
- Laparoscopic cholecystectomy, Acute cholecystitis, Early, Delayed
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early cholecystectomyProcedure or surgery
Also called First group
Early laparoscopic cholecystectomy for acute cholecystitis after admission
Delayed cholecystectomyProcedure or surgery
Also called Second group
Laparoscopic cholecystectomy well be done after a period on conservation
| Study group | Role | What they receive |
|---|---|---|
| Early cholecystectomy | Active comparator | Laparoscopic cholecystectomy well be done after the immediate admission Receives: Procedure: Early cholecystectomy |
| Delayed cholecystectomy | Active comparator | Laparoscopic cholecystectomy after a period of conservative treatment Receives: Procedure: Delayed cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time is assessed in minutes ,
Measured: 1 DAY
Secondary outcomes (4)
Perioperative complications
Intraoperative complications like bleeding , injury,
Measured: 5 weeks
Conversion rate
Conversion rate from laparoscopic to open and reason of conversion.
Measured: 1 DAY
hospital stay in days
hospital stay in days
Measured: 2 weeks
Period of giving antibiotics in days
Number of days giving the antibiotics
Measured: 2 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED ABDELLATIF, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130245
- Sponsor's protocol ID
- Early cholecystectomy
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02130245
- Acronym / sponsor ID
- Early cholecystectomy
- Conditions
- Acute Cholecystitis
- Keywords
- Laparoscopic cholecystectomy, Acute cholecystitis, Early, Delayed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 5 May 2014 (estimated)
- 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.
The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The hypothesis is that to do it as an early intervention after patient admission is better than delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.
Detailed description
Doing laparoscopic cholecystectomy for patients with acute cholecystitis as an early intervention after patient admission ( first group) or to do it after a while of treatment and conservation as a delayed cholecystectomy (second group) points of study include the hospital stay, interval for antibiotic, the easiness of the operative maneuver reflected by operative time, conversion and intraoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cholecystectomy | Active comparator | Procedure: Early cholecystectomyLaparoscopic cholecystectomy well be done after the immediate admission |
| Delayed cholecystectomy | Active comparator | Procedure: Delayed cholecystectomyLaparoscopic cholecystectomy after a period of conservative treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Proved acute cholecystitis clinical, radiologic
Key exclusion criteria (4 listed)
- Evidence of peritonitis
- ASA III or IV
- Previous upper abdominal surgery
- Pregnancy
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 |
|---|---|---|
| Early cholecystectomyAlso: First groupEarly laparoscopic cholecystectomy for acute cholecystitis after admission | Procedure or surgery | Early cholecystectomy |
| Delayed cholecystectomyAlso: Second groupLaparoscopic cholecystectomy well be done after a period on conservation | Procedure or surgery | Delayed cholecystectomy |
Primary outcome
Operative time
Time frame: 1 DAY
Operative time is assessed in minutes ,
4 secondary outcomes
Perioperative complications
Time frame: 5 weeks
Conversion rate
Time frame: 1 DAY
hospital stay in days
Time frame: 2 weeks
Period of giving antibiotics in days
Time frame: 2 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early cholecystectomy and Delayed cholecystectomy in people with Acute Cholecystitis, run by Mansoura 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 1 inclusion and 4 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 8 Apr 2015. 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 mohamed e abdellatif, md (00201115051680, surg_latif@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: 1 DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2015.