Wound Infection, SurgicalNCT07103707
Comparison of Frequency of Wound Infection Between Open and Laparoscopic Cholecystectomy
A study testing open cholecystectomy and Laparoscopic cholecystectomy in people with Wound Infection, Surgical, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the frequency of wound infection between open and laparoscopic cholecystectomy in adult patient aged 18- 65 years with symptomatic cholelithiasis admitted through OPD the main question it aims to answer are Does there is difference in the frequency of wound infection in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Infection, Surgical
- What is being tested?
- open cholecystectomy and Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both genders
- Patients aged 18 to 65 years
- Symptomatic cholelithiasis as per operational definition
- Undergoing cholecystectomy (open/laparoscopic)
- ASA score I/II (Annexure-II)
Who cannot join
- ● H/o diabetes mellitus
- H/o immunocompromised state (e.g. HIV, steroid use)
- H/o acute cholecystitis
- H/o empyema gallbladder
- H/o gallbladder perforation ● H/o choledocholithiasis
- H/o portal hypertension
- H/o abnormal blood clotting profiles (PTT >15 seconds, APTT >20 seconds)
- H/o pregnancy on HCG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Moeez u din khan
Peshawar, Khyber Pakhtunkhwa, 25000
Moeez u din khan, PGR GS, 03489548857, moeezk442@gmail.com
IJAZ UL HAQUE, PGR NSG, +923499223911, drijazulhaque712237@gmail.com
About this study
The goal of this clinical trial is to compare the frequency of wound infection between open and laparoscopic cholecystectomy in adult patient aged 18- 65 years with symptomatic cholelithiasis admitted through OPD the main question it aims to answer are
- Does there is difference in the frequency of wound infection in patients with open cholecystectomy as compared to laparoscopic cholecystectomy Researcher will compare the frequency of wound infection in participant undergoing open and laparoscopic cholecystectomy to see there is difference in frequency of wound infection between open and laparoscopic cholecystectomy Participants will be asked
- To Visit OPD after 1 week for follow up
- Keep record of symptoms like erythema, pain, cloudy drainage from the incision site
- Conditions
- Wound Infection, Surgical
- Being tested
- open cholecystectomy, Laparoscopic cholecystectomy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open cholecystectomyProcedure or surgery
standard open cholecystectomy performed under general anesthesia
Laparoscopic cholecystectomyProcedure or surgery
Standard laparoscopic cholecystectomy using minimally invasive technique
| Study group | Role | What they receive |
|---|---|---|
| open cholecystectomy | Active comparator | patient undergoing open cholecystectomy Receives: Procedure: open cholecystectomy |
| laparoscopic cholecystectomy | Active comparator | patient undergoing laparoscopic cholecystectomy Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of frequency of wound infection between open and laparoscopic cholecystectomy
to compare the frequency of wound infection in patients undergoing open and laparoscopic
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Infection, SurgicalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomization will performed by blocked randomization (61 in each group) 61 patient will be in open cholecystectomy group( A )while 61 patient will be in laparoscopic cholecystectomy group (B)
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Reading Hospital, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Moeez u din Khan, Lady Reading Hospital, Pakistan
- Investigators
- Ahmad faraz, AP GS(FCPS), Principal investigator, Lady reading hospital peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103707
- Sponsor's protocol ID
- 253/LRH/MTI
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Frequency of Wound Infection Between Open and Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07103707
- Acronym / sponsor ID
- 253/LRH/MTI
- Conditions
- Wound Infection, Surgical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Lady Reading Hospital, PakistanOther government
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 5 Aug 2025 (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 goal of this clinical trial is to compare the frequency of wound infection between open and laparoscopic cholecystectomy in adult patient aged 18- 65 years with symptomatic cholelithiasis admitted through OPD the main question it aims to answer are
- Does there is difference in the frequency of wound infection in patients with open cholecystectomy as compared to laparoscopic cholecystectomy Researcher will compare the frequency of wound infection in participant undergoing open and laparoscopic cholecystectomy to see there is difference in frequency of wound infection between open and laparoscopic cholecystectomy Participants will be asked
- To Visit OPD after 1 week for follow up
- Keep record of symptoms like erythema, pain, cloudy drainage from the incision site
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization will performed by blocked randomization (61 in each group) 61 patient will be in open cholecystectomy group( A )while 61 patient will be in laparoscopic cholecystectomy group (B)
| Arm | Type | Receives |
|---|---|---|
| open cholecystectomy | Active comparator | Procedure: open cholecystectomypatient undergoing open cholecystectomy |
| laparoscopic cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomypatient undergoing laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both genders
Key exclusion criteria (8 listed)
- ● H/o diabetes mellitus
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 |
|---|---|---|
| open cholecystectomystandard open cholecystectomy performed under general anesthesia | Procedure or surgery | open cholecystectomy |
| Laparoscopic cholecystectomyStandard laparoscopic cholecystectomy using minimally invasive technique | Procedure or surgery | laparoscopic cholecystectomy |
Primary outcome
comparison of frequency of wound infection between open and laparoscopic cholecystectomy
Time frame: 1 year
to compare the frequency of wound infection in patients undergoing open and laparoscopic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Ahmad faraz, AP GS(FCPS) principal investigator
Lady reading hospital peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open cholecystectomy and Laparoscopic cholecystectomy in people with Wound Infection, Surgical, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moeez u din khan, PGR GS (+923489548857, moeezk442@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of frequency of wound infection between open and laparoscopic cholecystectomy (time frame: 1 year). 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 5 Aug 2025.