Laparoscopic vs Open Appendectomy

NCT07841444 | Completed DMC

• 1 other identifier: No.517/DME/QAMC Bahawalpur
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Appendicitis; Superficial SSI

Keywords

Laparoscopic Appendectomy,; Open appendectomy,; Superficial Surgical Site Infection

Outcome Measures

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.

  Within 7 postoperative days after appendectomy.

Study Arms (2)

Laparoscopic Appendectomy

EXPERIMENTAL

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

Open Appendectomy

ACTIVE COMPARATOR

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

Laparoscopic appendectomy PROCEDURE

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.

Laparoscopic Appendectomy

Open Appendectomy PROCEDURE

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.

Open Appendectomy

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with generalized peritonitis or perforated appendicitis.
• Patients with significant comorbidities, including uncontrolled diabetes mellitus or immunosuppression.
• 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 bilirubin \>2 mg/dL.

Sponsors & Collaborators

• Quaid-e-Azam Medical College: lead

Study Sites (1)

Department of Surgery

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label randomized controlled trial. No additional study personnel, participants, surgeons, outcome assessors, or data analysts were masked to the assigned surgical intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a two-arm, parallel-group randomized controlled trial comparing laparoscopic appendectomy with open appendectomy in patients aged 15-60 years with acute appendicitis. A total of 276 eligible patients were randomly allocated in a 1:1 ratio using the lottery method, with 138 patients assigned to each group. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. All procedures were performed by the same consultant surgeon. Patients were followed for 7 postoperative days to assess the occurrence of superficial surgical site infection. No participant crossed over between intervention groups.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 25, 2026
• Study Start: January 24, 2026
• Primary Completion: July 23, 2026
• Study Completion: July 23, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)