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

21 de julio de 2026 actualizado por: Dr Yilmaz TURK, Ankara Etlik City Hospital

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

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yılmaz Türk, Operator Doctor
  • Número de teléfono: +90 +905321349903
  • Correo electrónico: yturk9@gmail.com

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turquía (Türkiye), 06170
        • Ankara Etlik Sehir Hastanesi
        • Contacto:
          • Yılmaz Türk, Operator Doctor
          • Número de teléfono: +905321349903
          • Correo electrónico: yturk9@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 10 mmHg Pneumoperitoneum
Participants assigned to this arm will undergo laparoscopic appendectomy using a pneumoperitoneum pressure of 10 mmHg throughout the procedure. Patients will be allocated using sealed opaque envelope randomization. All other perioperative management and surgical techniques will be standardized.
Procedimiento: Laparoscopic appendectomy with 10 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg.
Comparador activo: 15 mmHg Pneumoperitoneum
Participants assigned to this arm will undergo laparoscopic appendectomy using a pneumoperitoneum pressure of 15 mmHg throughout the procedure. Patients will be allocated using sealed opaque envelope randomization. All other perioperative management and surgical techniques will be standardized.
Procedimiento: Laparoscopic appendectomy with 15 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative pain (Numeric Rating Scale [NRS] 0-10)
Periodo de tiempo: 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.
At 6 and 24 hours postoperatively

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to first flatus
Periodo de tiempo: From the end of surgery until first passage of flatus, assessed up to hospital discharge (approximately 7 days)
Time from completion of surgery to the first passage of flatus, recorded in hours
From the end of surgery until first passage of flatus, assessed up to hospital discharge (approximately 7 days)
Length of hospital stay
Periodo de tiempo: From surgery until hospital discharge (up to 30 days)
Duration of hospitalization measured from the end of surgery until hospital discharge
From surgery until hospital discharge (up to 30 days)
Carbon dioxide (CO₂) volume required to achieve target pneumoperitoneum
Periodo de tiempo: At the beginning of surgery
The volume of carbon dioxide required to establish the target pneumoperitoneum pressure (10 mmHg or 15 mmHg) at the beginning of laparoscopic appendectomy will be recorded and compared between groups
At the beginning of surgery
Need for conversion to 15 mmHg pneumoperitoneum
Periodo de tiempo: During surgery
The proportion of participants initially assigned to 10 mmHg pneumoperitoneum who require conversion to 15 mmHg during surgery owing to inadequate operative exposure or technical difficulty.
During surgery
Postoperative ileus
Periodo de tiempo: Within 30 days after surgery
Incidence of postoperative ileus diagnosed according to clinical findings and need for additional management.
Within 30 days after surgery
Intra-abdominal abscess
Periodo de tiempo: Within 30 days after surgery
Incidence of postoperative intra-abdominal abscess confirmed clinically and/or radiologically.
Within 30 days after surgery
Surgical site infection
Periodo de tiempo: Within 30 days after surgery
Incidence of superficial or deep surgical site infection according to CDC criteria
Within 30 days after surgery
Postoperative analgesic consumption
Periodo de tiempo: From the end of surgery until 24 hours after surgery.
Total postoperative analgesic requirement during the hospitalization period.
From the end of surgery until 24 hours after surgery.
Surgical difficulty score
Periodo de tiempo: Immediately after completion of surgery
Surgical difficulty assessed immediately after completion of the procedure by the operating surgeon using a 5-point Likert Surgical Difficulty Scale (1 = very easy, 2 = easy, 3 = moderate, 4 = difficult, 5 = very difficult). Scores range from 1 to 5, with higher scores indicating greater surgical difficulty.
Immediately after completion of surgery
Operation time
Periodo de tiempo: During surgery
Total operative time measured from skin incision to skin closure and compared between the two pneumoperitoneum pressure groups
During surgery
Intraoperative Complications
Periodo de tiempo: During surgery
Incidence of intraoperative complications, including bleeding, bowel injury, vascular injury, or other procedure-related adverse events occurring during laparoscopic appendectomy
During surgery
Emergency department visit after discharge
Periodo de tiempo: Within 30 days after surgery
Number of participants requiring an emergency department visit related to postoperative complications after hospital discharge
Within 30 days after surgery
Reoperation
Periodo de tiempo: Within 30 days after surgery
Number of participants requiring any unplanned surgical reintervention related to postoperative complications
Within 30 days after surgery
postoperative complications
Periodo de tiempo: Within 30 days after surgery
Postoperative complications occurring within 30 days after surgery will be classified according to the Clavien-Dindo classification
Within 30 days after surgery
Leiden Surgical Rating Scale (LSRS)
Periodo de tiempo: Immediately after surgery
Surgical conditions will be evaluated by the operating surgeon using the Leiden Surgical Rating Scale (LSRS), a validated 5-point scale ranging from 1 (extremely poor conditions) to 5 (optimal surgical conditions)
Immediately after surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ankara Etlik City Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • 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/

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

27 de julio de 2026

Finalización primaria (Estimado)

27 de octubre de 2026

Finalización del estudio (Estimado)

27 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

27 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AnkaraEtlikGCYilmazTurk001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

I can give IPD on request after submission of paper

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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