Appendectomy, Laparoscopic, Intra Abdominal Pressure
Conditions
Keywords
pain, vas, flatus, pressure, appendicitis, intra-abdominal pressure
Brief summary
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
PROCEDURELaparoscopic appendectomy with 10 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg.
PROCEDURELaparoscopic appendectomy with 15 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will remain unaware of the assigned pneumoperitoneum pressure. Postoperative outcome assessment will be performed by personnel blinded to group allocation whenever feasible. Surgeons cannot be blinded because pneumoperitoneum pressure must be known during the procedure.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio using sealed opaque envelopes to undergo laparoscopic appendectomy using either 10 mmHg or 15 mmHg pneumoperitoneum. All other perioperative management and surgical techniques will be standardized between groups. Clinical outcomes will be compared between the two parallel intervention arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain (Numeric Rating Scale [NRS] 0-10) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to first flatus | 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 |
| Length of hospital stay | From surgery until hospital discharge (up to 30 days) | Duration of hospitalization measured from the end of surgery until hospital discharge |
| Carbon dioxide (CO₂) volume required to achieve target pneumoperitoneum | 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 |
| Need for conversion to 15 mmHg pneumoperitoneum | 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. |
| Postoperative ileus | Within 30 days after surgery | Incidence of postoperative ileus diagnosed according to clinical findings and need for additional management. |
| Intra-abdominal abscess | Within 30 days after surgery | Incidence of postoperative intra-abdominal abscess confirmed clinically and/or radiologically. |
| Surgical site infection | Within 30 days after surgery | Incidence of superficial or deep surgical site infection according to CDC criteria |
| Postoperative analgesic consumption | From the end of surgery until 24 hours after surgery. | Total postoperative analgesic requirement during the hospitalization period. |
| Surgical difficulty score | 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. |
| Operation time | During surgery | Total operative time measured from skin incision to skin closure and compared between the two pneumoperitoneum pressure groups |
| Intraoperative Complications | During surgery | Incidence of intraoperative complications, including bleeding, bowel injury, vascular injury, or other procedure-related adverse events occurring during laparoscopic appendectomy |
| Emergency department visit after discharge | Within 30 days after surgery | Number of participants requiring an emergency department visit related to postoperative complications after hospital discharge |
| Reoperation | Within 30 days after surgery | Number of participants requiring any unplanned surgical reintervention related to postoperative complications |
| postoperative complications | Within 30 days after surgery | Postoperative complications occurring within 30 days after surgery will be classified according to the Clavien-Dindo classification |
| Leiden Surgical Rating Scale (LSRS) | 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) |
Countries
Turkey (Türkiye)
Contacts
CONTACTYılmaz Türk, Operator Doctor
Outcome results
None listed