ClinicalTrials.gg
CompletedNCT07841444Updated Sep 25, 2026

Laparoscopic vs Open Appendectomy

An interventional study of Laparoscopic appendectomy and Open Appendectomy in Acute Appendicitis and Superficial SSI, sponsored by Quaid-e-Azam Medical College. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Quaid-e-Azam Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2026, registered Sep 2026).
Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
15 Years to 60 Years
Sex
All
01

Study summary

his randomized controlled trial was conducted to compare the frequency of superficial surgical site infections (SSIs) following laparoscopic appendectomy and open appendectomy in patients undergoing surgical treatment for acute appendicitis. The study was carried out in the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur, over a period of six months from 24 January 2026 to 23 July 2026. A total of 276 patients were included in the study, with 138 participants allocated to each treatment group. Patients enrolled in the trial were assigned to one of two study groups according to the study protocol. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. The purpose of the comparison was to determine whether the operative approach was associated with a difference in the occurrence of superficial surgical site infection after appendectomy. The study therefore evaluated two established surgical approaches for the same clinical condition while maintaining a randomized comparative design.

The primary outcome of the study was the frequency of superficial surgical site infection after appendectomy. Superficial surgical site infection refers to infection involving the skin and subcutaneous tissue at the surgical incision. The occurrence of this postoperative complication was assessed in participants in both groups using the same outcome definition and follow-up approach specified in the study protocol. The frequency of superficial SSI was then compared between the laparoscopic and open appendectomy groups.

The study was designed as an interventional randomized controlled trial. Participants were assigned to an intervention group on the basis of the study protocol rather than simply being observed according to the treatment they would otherwise have received. The intervention under investigation was the operative approach: laparoscopic appendectomy versus open appendectomy. No investigational drug or biologic product was evaluated, and the study was not conducted under a U.S. Food and Drug Administration Investigational New Drug application. Likewise, the study did not investigate a U.S. FDA-regulated device as the intervention and was not conducted under an Investigational Device Exemption.

The study population consisted of patients undergoing appendectomy at the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur. Eligible participants were enrolled according to the predefined inclusion and exclusion criteria of the study protocol. Participants in the laparoscopic group received appendectomy through the laparoscopic approach, whereas participants in the open group received appendectomy through the conventional open approach. Perioperative care and postoperative assessment were conducted according to the institutional surgical protocol and the requirements of the study. Data were collected prospectively during the study period and were used to assess the postoperative outcome of interest. The incidence of superficial surgical site infection was recorded for participants in each treatment group. The results were subsequently compared between the two groups to determine the observed difference in the frequency of superficial SSI following laparoscopic versus open appendectomy. The analysis was based on the predefined study outcome and the randomized allocation of participants.

The trial was conducted in a hospital surgical setting and included a total sample of 276 participants, providing 138 participants in each group. The study was intended to generate comparative clinical evidence regarding superficial wound infection after the two operative approaches. By directly comparing laparoscopic and open appendectomy within a randomized controlled trial, the study provides a structured assessment of the postoperative wound-related outcome in the enrolled patient population.

The study was undertaken after institutional ethical oversight and approval in accordance with the applicable requirements. Written informed consent was obtained from participants before enrollment, as specified in the study protocol. Participant information was handled confidentially, and study procedures were conducted in accordance with the approved protocol and institutional requirements.

The trial compares superficial surgical site infection between patients undergoing laparoscopic and open appendectomy at the study center. Its focus is the wound outcome associated with the two surgical approaches

Read the detailed description

Acute appendicitis is one of the most common surgical emergencies and appendectomy remains one of the most frequently performed emergency abdominal surgical procedures. Open appendectomy has traditionally been used as the standard operative approach, while laparoscopic appendectomy has increasingly been adopted because of its minimally invasive nature and potential postoperative advantages. Surgical site infection is an important postoperative complication of appendectomy because it can cause additional morbidity, delay wound healing and recovery, increase the need for postoperative treatment and follow-up, and potentially prolong healthcare utilization. The frequency of surgical site infection may vary according to the operative approach, patient characteristics, disease severity, operative technique, and perioperative management.

The present randomized controlled trial was conducted to compare the frequency of superficial surgical site infections following laparoscopic appendectomy and open appendectomy in patients presenting with acute appendicitis. The study was conducted in the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur, over six months, from 24 January 2026 to 23 July 2026. A total of 276 patients were included, with 138 participants allocated to each group.

The study population consisted of patients aged 15 to 60 years of either sex who presented with acute appendicitis and fulfilled the predefined eligibility criteria. Acute appendicitis was diagnosed on the basis of right iliac fossa pain with a visual analogue scale score of 3-10, positive rebound tenderness on clinical examination, and a white blood cell count greater than 10,000/mm³. Patients were eligible if the duration of symptoms was 48 hours or less. Both elective and emergency appendectomies were included.

Patients were excluded if they had generalized peritonitis, perforated appendicitis, uncontrolled diabetes mellitus, immunosuppression, previous abdominal surgery, chronic renal failure with serum creatinine above 1.5 mg/dL, or chronic liver disease with serum bilirubin above 2 mg/dL.

After approval of the study synopsis and institutional ethical approval, eligible patients were enrolled after obtaining informed written consent. Baseline demographic and clinical information was recorded using a structured data collection proforma. Variables included age, sex, duration of symptoms, height, weight, body mass index, obesity status, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery.

A body mass index greater than 27 kg/m² was considered obese and 27 kg/m² or below was considered non-obese. Residence was categorized as urban or rural according to documented residential address. Socioeconomic status was categorized according to monthly household income into poor class (≤20,000 PKR), middle class (21,000-40,000 PKR), and upper class (≥41,000 PKR). Diabetes mellitus was recorded on the basis of a known history of diabetes with ongoing treatment and controlled fasting blood glucose below 126 mg/dL on two consecutive measurements.

Participants were randomly allocated in a 1:1 ratio using a lottery method. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. All participants received prophylactic antibiotics according to the study protocol, and the duration of postoperative intravenous and outpatient antibiotic therapy was recorded. All operations were performed by the same consultant surgeon with at least five years of post-fellowship experience to maintain consistency in operative technique.

Patients were followed for seven postoperative days. During follow-up, the surgical wound was assessed for superficial surgical site infection and findings were recorded on the structured proforma. The primary outcome was the frequency of superficial surgical site infection within seven postoperative days. Superficial SSI was defined according to the predefined clinical criteria. A patient was considered to have superficial SSI if purulent wound discharge, redness around the wound or stitches, or postoperative fever exceeding 100°F was observed within seven days following surgery. The outcome was recorded as present or absent.

Demographic and clinical characteristics were recorded for comparison between groups. These included age, sex, duration of symptoms, BMI and obesity status, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery. Stratified analysis of superficial SSI was planned according to these characteristics.

The sample size was calculated using a 5% level of significance and 80% power, based on an anticipated superficial surgical site infection rate of 20% following laparoscopic appendectomy and 35% following open appendectomy. A total of 276 participants were included, with 138 in each group. Consecutive sampling was used for participant enrollment, followed by random allocation using the lottery method.

Operative duration was recorded for each participant and categorized into short and long duration according to the predefined study categorization for stratified analysis.

Statistical analysis was performed using SPSS version 25.0. Continuous variables were assessed for normality using the Shapiro-Wilk test. Normally distributed continuous variables were expressed as mean ± standard deviation, while non-normally distributed variables were presented as median with interquartile range. Categorical variables were summarized using frequencies and percentages. The independent-samples t-test was used for normally distributed continuous variables, while the Mann-Whitney U test was used for non-normally distributed variables. Categorical variables were compared using the Chi-square test or Fisher's exact test, as appropriate.

The primary outcome was compared between the laparoscopic and open appendectomy groups using the Chi-square test. Stratified analyses were performed according to age group, sex, duration of symptoms, BMI category, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery. A p-value of ≤0.05 was considered statistically significant.

The study specifically focused on superficial SSI occurring during the first seven postoperative days and did not combine superficial infection with deep or organ/space surgical site infection. The study was conducted after institutional ethical approval and approval of the study synopsis. Written informed consent was obtained from all participants before enrollment. Participant demographic and clinical information was recorded using a structured proforma, and postoperative wound findings were documented during the seven-day follow-up period.

02

Conditions studied

  • Acute Appendicitis
  • Superficial SSI

Browse trials for

Keywords

  • Laparoscopic Appendectomy,
  • Open appendectomy,
  • Superficial Surgical Site Infection
03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's enrollment of 276 is above the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Quaid-e-Azam Medical College is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 60 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

  • Patients aged 15-60 years of either sex.
  • Patients diagnosed with acute appendicitis according to the predefined operational definition and undergoing appendectomy.
  • Duration of symptoms less than 48 hours.
  • Both elective and emergency appendectomy cases.

Exclusion criteria

Exclusion Criteria:

  • Patients with generalized peritonitis or perforated appendicitis.
  • Patients with significant comorbidities, including uncontrolled diabetes mellitus or .
  • Patients with a history of previous abdominal surgery.
  • Patients with chronic renal failure, assessed on history and medical records, with serum creatinine >1.5 mg/dL.
  • Patients with chronic liver disease, assessed on history and medical records, with serum >2 mg/dL.
Terms in these criteria, in plain language(2)

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
276 participants (actual)

Study arms

  • Experimental
    Laparoscopic Appendectomy

    Participants assigned to this arm underwent laparoscopic appendectomy for acute appendicitis. A total of 138 patients were allocated to this group by 1:1 randomization using the lottery method. The procedure was performed by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days, and the occurrence of superficial surgical site infection was assessed based on predefined criteria, including purulent wound discharge, redness around the wound or stitches, or postoperative fever above 100°F.

    Procedure: Laparoscopic appendectomy

  • Active comparator
    Open Appendectomy

    Participants assigned to this arm underwent open appendectomy for acute appendicitis. A total of 138 patients were allocated to this group by 1:1 randomization using the lottery method. The procedure was performed by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days, and the occurrence of superficial surgical site infection was assessed based on predefined criteria, including purulent wound discharge, redness around the wound or stitches, or postoperative fever above 100°F.

    Procedure: Open Appendectomy

Interventions

  • ProcedureLaparoscopic appendectomy

    Laparoscopic appendectomy was performed for acute appendicitis in 138 randomized participants. The procedure was carried out by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days to assess superficial surgical site infection.

  • ProcedureOpen Appendectomy

    Open appendectomy was performed for acute appendicitis in 138 randomized participants. The procedure was carried out by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days to assess superficial surgical site infection.

06

What researchers measure

Primary outcomes

  1. Frequency of superficial surgical site infection (SSI) following laparoscopic versus open appendectomy

    The primary outcome is the occurrence of superficial surgical site infection within 7 postoperative days after appendectomy. SSI will be recorded as present if the patient develops purulent wound discharge, redness around the wound or stitches, or postoperative fever greater than 100°F during the follow-up period. The frequency of superficial SSI will be compared between the laparoscopic appendectomy and open appendectomy groups.

    Time frame: Within 7 postoperative days after appendectomy.

07

Study locations

1 site
  • Department of Surgery
    Bahawalpur, Punjab Province 63100, Pakistan
08

References and documents

Publications

  • 1. Ullah R, Shah M, Babar Y, Khan A. Comparison of laparoscopic and open appendectomy in terms of surgical site infection. Biol Clin Sci Res J. 2024;2024(1):696. doi:10.54112/bcsrj.v2024i1.696. 2. Khazaal AS. Laparoscopic vs open appendectomy: comparison on clinical outcome. World J Lap Surg. 2022;15(1):54-57. doi:10.5005/jp-journals-10033-1484. 3. Gu Q, Hua Y. Perforated appendicitis treated with laparoscopic appendicectomy or open appendicectomy: a meta-analysis. J Minim Access Surg. 2023;19(3):348-54. doi:10.4103/jmas.jmas_158_22. 4. Kumar M, Devkaran B, Verma DK, Mahajan P, Sharma VK, Galodha S. Comparative study of laparoscopic versus open appendicectomy for acute appendicitis: a prospective study. Ann Int Med Dent Res. 2021;7(2):4-8. doi:10.21276/aimdr.2021.7.2.SG2. 5. Niranjan AK, Kumar S. Prospective comparative study of laparoscopic appendectomy versus open appendectomy. Int J Pharm Clin Res. 2021;13(3):117-22. 6. Singh A, Sharma M, Abbas M. Laparoscopic versus open appendectomy: a comparative study. Int J Surg Sci. 2021;5(2):325-30. doi:10.33545/surgery.2021.v5.i2f.716. 7. Labricciosa FM, Sartelli M, Barbadoro P, Abbo LM, Ansaloni L, Coccolini F, et al. Epidemiology and risk factors for superficial surgical site infections after appendectomy for acute appendicitis: a secondary data analysis. Surg Infect (Larchmt). 2021;22(2):227-33. doi:10.1089/sur.2020.069. 8. Sayed AA, Abd El-Maksood IM, Mohammed RI. A comparative study of laparoscopic and open appendectomy. Med J Cairo Univ. 2021;89(1):155-61. doi:10.21608/mjcu.2021.153782. 9. Zeeshan M, Qayyum MS, Bashir R, Ahsan M, Saadi AR, Raza MA. Comparison of wound infection rate in open appendectomy (OA) vs laparoscopic appendectomy (LA). J Popul Ther Clin Pharmacol. 2024;31(6):688-93. doi:10.53555/jptcp.v31i6.6553. 10. Güler Y, Karabulut Z, Çaliş H, Şengül S. Comparison of laparoscopic and open appendectomy on wound infection and healing in complicated appendicitis. Int Wound J. 2020;17(4):957-65. doi:10.1111

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers because the study data contain participant-level information and will be retained by the research team in accordance with institutional policies and ethical requirements. Only aggregated, anonymized results will be reported.

09

Timeline

1 registry update 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 Jan 2026 to primary completion in Jul 2026, 5 months.

Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 5 months is below that.

Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.

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

Registered
Sep 16, 2026
First posted
Sep 25, 2026
StartActual
Jan 24, 2026
Primary completionActual
Jul 23, 2026
CompletionActual
Jul 23, 2026
Last update
Sep 25, 2026
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.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841444
Lead sponsor
Quaid-e-Azam Medical College
Responsible party
Asad Shabbir (Principal Investigator, Quaid-e-Azam Medical College) — Principal investigator
First posted
Sep 25, 2026
Start date
Jan 24, 2026
Primary completion
Jul 23, 2026
Completion
Jul 23, 2026
Last update
Sep 25, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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