Comparison of Standard Pneumoperitoneum Pressures in Laparoscopic Appendectomy: Clinical Outcomes of 10 mmHg Versus 15 mmHg Intra-abdominal Pressure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Postoperative pain (Numeric Rating Scale [NRS] 0-10)
研究概览
简要总结
This prospective, randomized controlled trial aims to compare the clinical outcomes of laparoscopic appendectomy performed under two standard pneumoperitoneum pressures (10 mmHg and 15 mmHg). The primary objective is to evaluate postoperative pain, while secondary outcomes include operative time, conversion rate, time to first flatus and bowel movement, length of hospital stay, postoperative ileus, and intra-abdominal abscess formation. The study will determine whether lower-pressure pneumoperitoneum provides comparable surgical conditions while improving postoperative recovery.
详细描述
Laparoscopic appendectomy is the standard surgical treatment for acute appendicitis. Carbon dioxide pneumoperitoneum is essential for adequate visualization and operative exposure; however, the optimal intra-abdominal pressure remains controversial. Standard pneumoperitoneum pressures of 12-15 mmHg provide satisfactory visualization but may contribute to increased postoperative pain and adverse cardiopulmonary effects. Lower-pressure pneumoperitoneum has the potential to reduce postoperative discomfort but may increase technical difficulty during surgery.
This single-center, prospective, randomized controlled trial will be conducted at Ankara Etlik City Hospital. Adult patients undergoing laparoscopic appendectomy for acute appendicitis will be randomly assigned to undergo surgery with either 10 mmHg or 15 mmHg pneumoperitoneum. All other perioperative management and surgical techniques will be standardized.
The primary outcome is postoperative pain assessed using the Numeric Rating Scale (NRS). Secondary outcomes include operative time, conversion to open surgery, time to first flatus, time to first bowel movement, length of hospital stay, postoperative ileus, postoperative intra-abdominal abscess, emergency department readmission, and postoperative complications. Patients will be followed according to the institutional postoperative care protocol, including outpatient follow-up for the assessment of postoperative complications.
The results of this study are expected to provide evidence regarding the optimal pneumoperitoneum pressure during laparoscopic appendectomy by balancing surgical exposure with postoperative recovery and patient safety.
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
- Single (Participant)
盲法说明
Participants will remain unaware of the assigned pneumoperitoneum pressure. Postoperative outcome assessment will be performed by personnel blinded to group allocation whenever feasible. Surgeons cannot be blinded because pneumoperitoneum pressure must be known during the procedure.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years.
- •Clinical and/or radiological diagnosis of acute appendicitis.
- •Planned laparoscopic appendectomy(Uncomplicated acute appendicitis considered suitable for laparoscopic management).
- •ASA physical status I-III.
- •Written informed consent.
排除标准
- •Age <18 years and >60 years
- •Pregnancy
- •Appendiceal mass or suspected appendiceal malignancy
- •Diffuse peritonitis requiring planned open surgery
- •Severe cardiopulmonary disease in whom pneumoperitoneum pressure cannot be standardized
- •Previous extensive abdominal surgery causing expected severe adhesions
- •Patients requiring additional major abdominal procedure
- •Missing consent
- •Incomplete postoperative follow-up
- •Patients managed non-operatively without surgery
结局指标
主要结局
Postoperative pain (Numeric Rating Scale [NRS] 0-10)
时间窗: At 6 and 24 hours postoperatively
Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). Pain scores will be compared between the 10 mmHg and 15 mmHg pneumoperitoneum groups.
次要结局
- Postoperative analgesic consumption(From the end of surgery until 24 hours after surgery.)
- Time to first flatus(From the end of surgery until first passage of flatus, assessed up to hospital discharge (approximately 7 days))
- Length of hospital stay(From surgery until hospital discharge (up to 30 days))
- Carbon dioxide (CO₂) volume required to achieve target pneumoperitoneum(At the beginning of surgery)
- Need for conversion to 15 mmHg pneumoperitoneum(During surgery)
- Postoperative ileus(Within 30 days after surgery)
- Intra-abdominal abscess(Within 30 days after surgery)
- Surgical site infection(Within 30 days after surgery)
- Surgical difficulty score(Immediately after completion of surgery)
- Operation time(During surgery)
- Intraoperative Complications(During surgery)
- Emergency department visit after discharge(Within 30 days after surgery)
- Reoperation(Within 30 days after surgery)
- postoperative complications(Within 30 days after surgery)
- Leiden Surgical Rating Scale (LSRS)(Immediately after surgery)
研究者
Dr Yilmaz TURK
Operator Doctor
Ankara Etlik City Hospital