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NCT Number: NCT07727499

Laparoscopic Appendectomy: 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.

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Key information

Conditions

Appendectomy, Laparoscopic Appendicitis Cecal Diseases Digestive System Diseases Flatulence Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intra Abdominal Pressure Intraabdominal Infections Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location contact

Yılmaz Türk, Operator Doctor

CONTACT

[email protected]

+905321349903

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic appendectomy with 10 mmHg pneumoperitoneum

Procedure

Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg.

Laparoscopic appendectomy with 15 mmHg pneumoperitoneum

Procedure

Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.

Primary outcomes

  1. Postoperative pain (Numeric Rating Scale [NRS] 0-10)

    Time frame: 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.

Secondary outcomes

  1. Time to first flatus

    Time frame: 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

  2. Length of hospital stay

    Time frame: From surgery until hospital discharge (up to 30 days)

    Duration of hospitalization measured from the end of surgery until hospital discharge

  3. Carbon dioxide (CO₂) volume required to achieve target pneumoperitoneum

    Time frame: 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

  4. Need for conversion to 15 mmHg pneumoperitoneum

    Time frame: 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.

  5. Postoperative ileus

    Time frame: Within 30 days after surgery

    Incidence of postoperative ileus diagnosed according to clinical findings and need for additional management.

  6. Intra-abdominal abscess

    Time frame: Within 30 days after surgery

    Incidence of postoperative intra-abdominal abscess confirmed clinically and/or radiologically.

  7. Surgical site infection

    Time frame: Within 30 days after surgery

    Incidence of superficial or deep surgical site infection according to CDC criteria

  8. Postoperative analgesic consumption

    Time frame: From the end of surgery until 24 hours after surgery.

    Total postoperative analgesic requirement during the hospitalization period.

  9. Surgical difficulty score

    Time frame: 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.

  10. Operation time

    Time frame: During surgery

    Total operative time measured from skin incision to skin closure and compared between the two pneumoperitoneum pressure groups

  11. Intraoperative Complications

    Time frame: During surgery

    Incidence of intraoperative complications, including bleeding, bowel injury, vascular injury, or other procedure-related adverse events occurring during laparoscopic appendectomy

  12. Emergency department visit after discharge

    Time frame: Within 30 days after surgery

    Number of participants requiring an emergency department visit related to postoperative complications after hospital discharge

  13. Reoperation

    Time frame: Within 30 days after surgery

    Number of participants requiring any unplanned surgical reintervention related to postoperative complications

  14. postoperative complications

    Time frame: Within 30 days after surgery

    Postoperative complications occurring within 30 days after surgery will be classified according to the Clavien-Dindo classification

  15. Leiden Surgical Rating Scale (LSRS)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Yılmaz Türk, Operator Doctor

CONTACT

[email protected]

+905321349903 ext. +90

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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