Comparing wound infection risk after open versus laparoscopic gallbladder removal
Comparison of Frequency of Wound Infection Between Open and Laparoscopic Cholecystectomy
This will see if open or laparoscopic gallbladder removal causes more wound infections in adults 18–65 with symptomatic gallstones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Lady Reading Hospital, Pakistan Government |
| Locations | 1 site (Peshawar, Khyber Pakhtunkhwa) |
| Trial ID | NCT07103707 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–65 with symptomatic cholelithiasis who are ASA I–II and scheduled for cholecystectomy will undergo either open or laparoscopic surgery and have their incision sites monitored for infection. Wound symptoms such as redness, pain, and cloudy drainage will be recorded and participants will return for an outpatient follow-up at one week. Patients with diabetes, immunocompromise, acute cholecystitis, gallbladder perforation, choledocholithiasis, portal hypertension, abnormal clotting, or pregnancy are excluded. The comparison is conducted at a single center (Lady Reading Hospital/associated site in Peshawar) to determine differences in postoperative wound infection frequency.
Who should consider this trial
Good fit: Adults 18–65 with symptomatic cholelithiasis who are ASA I–II and planned for open or laparoscopic cholecystectomy, and who do not have diabetes or other listed exclusion conditions, are ideal candidates.
Not a fit: Patients with diabetes, immunocompromised states, acute cholecystitis, empyema, gallbladder perforation, choledocholithiasis, portal hypertension, abnormal clotting tests, or pregnancy are excluded and would not be expected to benefit from joining this comparison.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the approach with lower wound infection risk and reduce postoperative complications and recovery time.
How similar studies have performed: Previous research generally shows lower wound infection rates after laparoscopic compared with open cholecystectomy, so this study repeats that comparison in a local patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both genders * Patients aged 18 to 65 years * Symptomatic cholelithiasis as per operational definition * Undergoing cholecystectomy (open/laparoscopic) * ASA score I/II (Annexure-II) Exclusion Criteria: * ● 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
Where this trial is running
Peshawar, Khyber Pakhtunkhwa
- Moeez u din khan — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
Study contacts
- Principal investigator: Ahmad faraz, AP GS(FCPS) — Lady reading hospital peshawar
- Study coordinator: Moeez u din khan, PGR GS
- Email: moeezk442@gmail.com
- Phone: +923489548857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.