Laparoscopic CholecystectomyNCT05555810
Suture Ligation Versus Clipping of Cystic Duct and Artery During Laparoscopic Cholecystectomy
A study testing clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy in people with Laparoscopic Cholecystectomy, run by Assiut University.
Trial summary
The investigators will compare between clipping and ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy. This is the main question that will be discussed in the review. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Dec 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with cholecystitis admitted at Assuit University Hospital and planed for lap. cholecystectomy the period of the study
Who cannot join
- Any case not candidate for laparoscopic cholecystectomy and we must do it by open technique .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Suture Ligation Versus Clipping of Cystic Duct and Artery During Laparoscopic Cholecystectomy . " A Prospective Comparative Study"
The investigators will compare between clipping and ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy. This is the main question that will be discussed in the review.
Read the detailed description
cholecystectomy is the second most commonly intra-abdominal operation worldwide after Appendectomy. In standard surgery ,there are increase incidence of wound infection,bleeding , discomfort and hospital stay so laparoscopic surgery has become the best choice for treatment of symptomatic and uncomplicated Gall bladder stones and hernia repair.
Once laparoscopic cholecystectomy emerged controversies persist with regard to the best method to ligate the cystic duct and artery. They may be ligated by separate and multiple ligatures by absorbable suture material, or using absorbable clips.
Suture ligation of cystic duct appeared to be more cost effective.On the other hand, the application of clips shown to have some drawbacks such as dislodgement and bile leakage and increase liability of long term clip migration which resulted in biliary stone formation or bile duct stenosis and also they are expensive .Another complication of clips that they may ulcerated through the duodenum.
Ligation takes more time than applying a clip, and it needs well training, but it is feasible, cost- effective and safe alternative method to secure cystic duct and artery in laparoscopic cholecystectomy.
The Aim of this study is to compare the two different methods; Tie versus clipping, for securing cystic duct and artery in laparoscopic cholecystectomy. In terms of efficacy and safety, and also the difference in the times of operations in both methods
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomyProcedure or surgery
The investigators will make a comparison between clipping and ligation of cystic duct and cystic artery during Laparoscopic cholecystectomy and trying to know advantages and disadvantages of each technique .
| Study group | Role | What they receive |
|---|---|---|
| Suture ligation of cystic duct and artery | Active comparator | The investigators will ligate cystic duct and artery by traditional sutures during laparoscopic cholecystectomy . Receives: Procedure: clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy |
| Application of clips | Active comparator | The investigators will put a clips on the cystic duct and artery during laparoscopic cholecystectomy. Receives: Procedure: clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficiency of closure of cystic duct and artery after cutting them during laparoscopic cholecystectomy
The investigators will seek to know the incidence of postoperative complications of laparoscopic cholecystectomy (as signs of biliary leakage as pain, jaundice and raised serum bilirubin level and follow up the drain inserted after doing laparoscopic cholecystectomy)
then the investigators will make a comparison between incidence of these complication after closure of cystic duct and artery either by clipping or ligation by sutures.
The investigators will try to know rate of advantages disadvantages of each technique also do our best to make strategies for improving efficiency and safety.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Jun 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will secure Cystic duct and artery with traditional sutures(ligation) in a group. In the another group the cystic duct and artery will be put a clips .
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Sayed, Assiut University
- Investigators
- Mohamed Korany, PHD, Study director, Assut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555810
- Sponsor's protocol ID
- lclc
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Dijk AH, van Roessel S, de Reuver PR, Boerma D, Boermeester MA, Donkervoort SC. Systematic review of cystic duct closure techniques in relation to prevention of bile duct leakage after laparoscopic cholecystectomy. World J Gastrointest Surg. 2018 Sep 27;10(6):57-69. doi: 10.4240/wjgs.v10.i6.57.
PubMed 30283606Singal R, Sharma A, Zaman M. The Safety and Efficacy of Clipless versus Conventional Laparoscopic Cholecystectomy - our Experience in an Indian Rural Center. Maedica (Bucur). 2018 Mar;13(1):34-43.
PubMed 29868139
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Ligation Versus Clipping of Cystic Duct and Artery During Laparoscopic Cholecystectomy . " A Prospective Comparative Study"
- ClinicalTrials.gov ID
- NCT05555810
- Acronym / sponsor ID
- lclc
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Sep 2022 (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.
The investigators will compare between clipping and ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy. This is the main question that will be discussed in the review.
Detailed description
cholecystectomy is the second most commonly intra-abdominal operation worldwide after Appendectomy. In standard surgery ,there are increase incidence of wound infection,bleeding , discomfort and hospital stay so laparoscopic surgery has become the best choice for treatment of symptomatic and uncomplicated Gall bladder stones and hernia repair.
Once laparoscopic cholecystectomy emerged controversies persist with regard to the best method to ligate the cystic duct and artery. They may be ligated by separate and multiple ligatures by absorbable suture material, or using absorbable clips.
Suture ligation of cystic duct appeared to be more cost effective.On the other hand, the application of clips shown to have some drawbacks such as dislodgement and bile leakage and increase liability of long term clip migration which resulted in biliary stone formation or bile duct stenosis and also they are expensive .Another complication of clips that they may ulcerated through the duodenum.
Ligation takes more time than applying a clip, and it needs well training, but it is feasible, cost- effective and safe alternative method to secure cystic duct and artery in laparoscopic cholecystectomy.
The Aim of this study is to compare the two different methods; Tie versus clipping, for securing cystic duct and artery in laparoscopic cholecystectomy. In terms of efficacy and safety, and also the difference in the times of operations in both methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will secure Cystic duct and artery with traditional sutures(ligation) in a group. In the another group the cystic duct and artery will be put a clips .
| Arm | Type | Receives |
|---|---|---|
| Suture ligation of cystic duct and artery | Active comparator | Procedure: clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomyThe investigators will ligate cystic duct and artery by traditional sutures during laparoscopic cholecystectomy . |
| Application of clips | Active comparator | Procedure: clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomyThe investigators will put a clips on the cystic duct and artery during laparoscopic cholecystectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with cholecystitis admitted at Assuit University Hospital and planed for lap. cholecystectomy the period of the study
Key exclusion criteria (1 listed)
- Any case not candidate for laparoscopic cholecystectomy and we must do it by open technique .
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 |
|---|---|---|
| clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomyThe investigators will make a comparison between clipping and ligation of cystic duct and cystic artery during Laparoscopic cholecystectomy and trying to know advantages and disadvantages of each technique . | Procedure or surgery | Application of clips, Suture ligation of cystic duct and artery |
Primary outcome
safety and efficiency of closure of cystic duct and artery after cutting them during laparoscopic cholecystectomy
Time frame: one month
The investigators will seek to know the incidence of postoperative complications of laparoscopic cholecystectomy (as signs of biliary leakage as pain, jaundice and raised serum bilirubin level and follow up the drain inserted after doing laparoscopic cholecystectomy) then the investigators will make a comparison between incidence of these complication after closure of cystic duct and artery either by clipping or ligation by sutures. The investigators will try to know rate of advantages disadvantages of each technique also do our best to make strategies for improving efficiency and safety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 30283606van Dijk AH, van Roessel S, de Reuver PR, Boerma D, Boermeester MA, Donkervoort SC. Systematic review of cystic duct closure techniques in relation to prevention of bile duct leakage after laparoscopic cholecystectomy. World J Gastrointest Surg. 2018 Sep 27;10(6):57-69. doi: 10.4240/wjgs.v10.i6.57.
- Background: PubMed 29868139Singal R, Sharma A, Zaman M. The Safety and Efficacy of Clipless versus Conventional Laparoscopic Cholecystectomy - our Experience in an Indian Rural Center. Maedica (Bucur). 2018 Mar;13(1):34-43.
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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.
Mohamed Korany, PHD study director
Assut University
Questions about this trial
What is this clinical trial studying?
A study testing clipping or ligation of the cystic duct and the cystic artery in Laparoscopic cholecystectomy in people with Laparoscopic Cholecystectomy, run by Assiut University.
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 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 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Morsi Morsi, phd (00201006727303, profmorsy6060@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and efficiency of closure of cystic duct and artery after cutting them during laparoscopic cholecystectomy (time frame: one month). 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 NCT05555810, which also lists 2 linked publications.
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 27 Sep 2022.