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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Appendectomy, Laparoscopic; Intra Abdominal Pressure
• Intervention / Treatment: Procedure: Laparoscopic appendectomy with 10 mmHg pneumoperitoneum; Procedure: Laparoscopic appendectomy with 15 mmHg pneumoperitoneum

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yılmaz Türk, Operator Doctor; Phone Number: +90 +905321349903; Email: yturk9@gmail.com

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06170
      • Ankara Etlik Şehir Hastanesi
      • Contact: Yılmaz Türk, Operator Doctor; Phone Number: +905321349903; Email: yturk9@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Laparoscopic appendectomy with 10 mmHg pneumoperitoneum; Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg.
Active Comparator: 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.	Procedure: Laparoscopic appendectomy with 15 mmHg pneumoperitoneum; Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain (Numeric Rating Scale [NRS] 0-10)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first flatus	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	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	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	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	Incidence of postoperative ileus diagnosed according to clinical findings and need for additional management.	Within 30 days after surgery
Intra-abdominal abscess	Incidence of postoperative intra-abdominal abscess confirmed clinically and/or radiologically.	Within 30 days after surgery
Surgical site infection	Incidence of superficial or deep surgical site infection according to CDC criteria	Within 30 days after surgery
Postoperative analgesic consumption	Total postoperative analgesic requirement during the hospitalization period.	From the end of surgery until 24 hours after surgery.
Surgical difficulty score	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	Total operative time measured from skin incision to skin closure and compared between the two pneumoperitoneum pressure groups	During surgery
Intraoperative Complications	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	Number of participants requiring an emergency department visit related to postoperative complications after hospital discharge	Within 30 days after surgery
Reoperation	Number of participants requiring any unplanned surgical reintervention related to postoperative complications	Within 30 days after surgery
postoperative complications	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)	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

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Publications and helpful links

General 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/

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 27, 2026
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): October 27, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pressure; pain; intra-abdominal pressure; appendicitis; flatus; vas
• Additional Relevant MeSH Terms: Neurologic Manifestations; Signs and Symptoms, Digestive; Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Appendicitis; Flatulence
• Other Study ID Numbers: AnkaraEtlikGCYilmazTurk001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I can give IPD on request after submission of paper

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No