Laparoscopic Appendectomy: Outcomes of 10 mmHg Versus 15 mmHg Intra-abdominal Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic appendectomy with 10 mmHg pneumoperitoneum, Laparoscopic appendectomy with 15 mmHg pneumoperitoneum.
- Who it may be relevant to
- Registry conditions: Appendectomy, Laparoscopic, Intra Abdominal Pressure. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Standard Pneumoperitoneum Pressures in Laparoscopic Appendectomy: Clinical Outcomes of 10 mmHg Versus 15 mmHg Intra-abdominal Pressure
Overview
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.
Detailed description
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.
Interventions
- Procedure Laparoscopic appendectomy with 10 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg. - Procedure Laparoscopic appendectomy with 15 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.
Primary outcome measures
- Postoperative pain (Numeric Rating Scale [NRS] 0-10) [Time frame: At 6 and 24 hours postoperatively]
Secondary outcome measures (12)
- Time to first flatus [Time frame: From the end of surgery until first passage of flatus, assessed up to hospital discharge (approximately 7 days)]
- Length of hospital stay [Time frame: From surgery until hospital discharge (up to 30 days)]
- Carbon dioxide (CO₂) volume required to achieve target pneumoperitoneum [Time frame: At the beginning of surgery]
- Need for conversion to 15 mmHg pneumoperitoneum [Time frame: During surgery]
- Postoperative ileus [Time frame: Within 30 days after surgery]
- Intra-abdominal abscess [Time frame: Within 30 days after surgery]
- Surgical site infection [Time frame: Within 30 days after surgery]
- Postoperative analgesic consumption [Time frame: From the end of surgery until 24 hours after surgery.]
- Surgical difficulty score [Time frame: Immediately after completion of surgery]
- Operation time [Time frame: During surgery]
- Intraoperative Complications [Time frame: During surgery]
- Emergency department visit after discharge [Time frame: Within 30 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Ankara Etlik Şehir Hastanesi — Ankara
Publications
- 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/
Identifiers
NCT: NCT07727499 · AnkaraEtlikGCYilmazTurk001