Comparison of Standard Pneumoperitoneum Pressures in Laparoscopic Appendectomy: Clinical Outcomes of 10 mmHg Versus 15 mmHg Intra-abdominal Pressure
| Registry | NCT07727499 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 150 (Estimated) |
| Sponsor | Ankara Etlik City Hospital (Other gov) |
| Conditions | Appendectomy, Laparoscopic, Intra Abdominal Pressure |
| Interventions | Laparoscopic appendectomy with 10 mmHg pneumoperitoneum, Laparoscopic appendectomy with 15 mmHg pneumoperitoneum (Procedure) |
| Dates | start 2026-07-27 (estimated), primary completion 2026-10-27 (estimated), completion 2027-10-27 (estimated), first posted 2026-07-27, last updated 2026-07-27 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Appendectomy, Laparoscopic All trials for Intra Abdominal Pressure All trials of Laparoscopic appendectomy with 10 mmHg pneumoperitoneum All trials of Laparoscopic appendectomy with 15 mmHg pneumoperitoneum
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 10 mmHg Pneumoperitoneum | Active comparator | Procedure: Laparoscopic appendectomy with 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. |
| 15 mmHg Pneumoperitoneum | Active comparator | Procedure: Laparoscopic appendectomy with 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. |
Sex: All, ages: 18 Years to 60 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Ankara Etlik Şehir Hastanesi | Ankara, Yenimahalle | Turkey (Türkiye) |