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临床试验/NCT07837531
NCT07837531尚未招募不适用

Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass: A Comparative Study

Assiut University0 个研究点目标入组 100 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Total Length of Hospital Stay

研究概览

简要总结

This study compares two standard treatment approaches for patients presenting with an appendicular mass, an inflammatory lump that forms when the appendix becomes severely inflamed and walled off by surrounding abdominal tissues.

The traditional treatment involves conservative medical therapy using intravenous antibiotics followed by an elective interval surgery to remove the appendix 6 to 8 weeks later. Alternatively, advances in minimally invasive surgery allow for an immediate keyhole operation (laparoscopic appendectomy) performed during the initial hospital admission. The goal of this study is to evaluate which approach leads to shorter total hospital stays, faster recovery, and fewer complications.

Participants will be assigned to one of two treatment groups:

  • Group A (Immediate Laparoscopic Appendectomy): Participants undergo laparoscopic surgery to remove the appendix within 24 hours of hospital admission.
  • Group B (Interval Laparoscopic Appendectomy): Participants receive initial intravenous antibiotics in the hospital until symptoms resolve. After discharge, they return 6 to 8 weeks later for elective laparoscopic surgery.

Participants in both groups will be monitored throughout their hospital stay and will attend follow-up visits at 1, 3, and 6 months postoperatively to assess recovery, wound healing, and any potential complications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18 years or older
  • •Clinical diagnosis of appendicular mass confirmed by abdominal ultrasonography and/or abdominal CT scan
  • •Presentation within 72 hours of symptom onset
  • •Provision of written informed consent

排除标准

  • •Generalized peritonitis or perforation with free intraperitoneal air
  • •Appendicular abscess > 5 cm not amenable to percutaneous drainage
  • •History of previous abdominal surgeries (contraindication to laparoscopy)
  • •American Society of Anesthesiologists (ASA) physical status classification ≥ IV
  • •Severe shock or sepsis requiring preoperative intensive care unit (ICU) admission
  • •Suspected cecal malignancy or colonic neoplasm
  • •Pregnancy

研究组 & 干预措施

Group A: Immediate Laparoscopic Appendectomy

Experimental

Patients undergo immediate laparoscopic appendectomy within 24 hours of admission. The procedure utilizes a standard 3-port laparoscopic technique (one 10 mm umbilical camera port and two 5 mm working ports), blunt and sharp adhesiolysis to isolate the inflamed appendix, appendix resection via endoloop or endoscopic stapler, warm saline peritoneal lavage (3-5 L), and abdominal drain placement if indicated.

干预措施: Immediate Laparoscopic Appendectomy (Procedure)

Group B: Interval Laparoscopic Appendectomy

Active Comparator

Patients receive initial conservative medical treatment with intravenous antibiotics (third-generation cephalosporin, metronidazole, and amikacin) along with analgesics, monitored via clinical examination and ultrasound every 48 hours until symptom resolution and discharge. Patients subsequently undergo elective interval laparoscopic appendectomy 6 to 8 weeks later using the same standard 3-port technique.

干预措施: Interval Laparoscopic Appendectomy (Procedure)

结局指标

主要结局

Total Length of Hospital Stay

时间窗: Up to 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Youhanna Bahgat Hosny Loundy

Resident of General Surgery

Assiut University

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