Comparison of the Frequency of Superficial Surgical Site Infections Between Laparoscopic Versus Open Appendectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Frequency of superficial surgical site infection (SSI) following laparoscopic versus open appendectomy
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 15 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Laparoscopic appendectomy (Procedure)
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.
干预措施: Open Appendectomy (Procedure)
结局指标
主要结局
Frequency of superficial surgical site infection (SSI) following laparoscopic versus open appendectomy
时间窗: Within 7 postoperative days after 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.
次要结局
未报告次要终点
研究者
Asad Shabbir
Principal Investigator
Quaid-e-Azam Medical College
