Laparoscopic Appendectomy: Outcomes of 10 mmHg Versus 15 mmHg Intra-abdominal Pressure

Официальное название

Comparison of Standard Pneumoperitoneum Pressures in Laparoscopic Appendectomy: Clinical Outcomes of 10 mmHg Versus 15 mmHg Intra-abdominal Pressure

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Laparoscopic appendectomy with 10 mmHg pneumoperitoneum
  Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg.
• Процедура Laparoscopic appendectomy with 15 mmHg pneumoperitoneum
  Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.

Первичные конечные точки

• Postoperative pain (Numeric Rating Scale [NRS] 0-10) [Срок оценки: At 6 and 24 hours postoperatively]

Вторичные конечные точки (12)

• Time to first flatus [Срок оценки: From the end of surgery until first passage of flatus, assessed up to hospital discharge (approximately 7 days)]
• Length of hospital stay [Срок оценки: From surgery until hospital discharge (up to 30 days)]
• Carbon dioxide (CO₂) volume required to achieve target pneumoperitoneum [Срок оценки: At the beginning of surgery]
• Need for conversion to 15 mmHg pneumoperitoneum [Срок оценки: During surgery]
• Postoperative ileus [Срок оценки: Within 30 days after surgery]
• Intra-abdominal abscess [Срок оценки: Within 30 days after surgery]
• Surgical site infection [Срок оценки: Within 30 days after surgery]
• Postoperative analgesic consumption [Срок оценки: From the end of surgery until 24 hours after surgery.]
• Surgical difficulty score [Срок оценки: Immediately after completion of surgery]
• Operation time [Срок оценки: During surgery]
• Intraoperative Complications [Срок оценки: During surgery]
• Emergency department visit after discharge [Срок оценки: Within 30 days after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Etlik Şehir Hastanesi — Ankara

Публикации

• https://academic.oup.com/gastro/article/doi/10.1093/gastro/goae052/7717317?utm_source=chatgpt.com
• https://journals.lww.com/njcp/fulltext/2024/06000/low_pressure_versus_standard_pressure.10.aspx?utm_source=chatgpt.com&__cf_chl_f_tk=Eb29rzCFkj3a_dXPqeUg.Gp3YmpTD2NNq9oCDSCAHjo-1783178717-1.0.1.1-uuVgHTnAcUecXo437tA9Setum0rqkaXoaoMcGgklnPQ
• https://pubmed.ncbi.nlm.nih.gov/20306755/
• https://pubmed.ncbi.nlm.nih.gov/24503370/
• https://pubmed.ncbi.nlm.nih.gov/26275545/
• https://pubmed.ncbi.nlm.nih.gov/32253560/

Идентификаторы

NCT: NCT07727499 · AnkaraEtlikGCYilmazTurk001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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