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

ConditionsAppendectomy, LaparoscopicIntra Abdominal Pressure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAnkara Etlik City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age <18 years and >60 years

Pregnancy

Appendiceal mass or suspected appendiceal malignancy

Diffuse peritonitis requiring planned open surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic appendectomy with 10 mmHg pneumoperitoneum

    Procedure/Surgery

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

  • Laparoscopic appendectomy with 15 mmHg pneumoperitoneum

    Procedure/Surgery

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: 10 mmHg PneumoperitoneumActive comparator 1 intervention
Group B: 15 mmHg PneumoperitoneumActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 6 and 24 hours postoperatively

Secondary outcomes

1

Time to first flatus

Time from completion of surgery to the first passage of flatus, recorded in hours

Time frame
From the end of surgery until first passage of flatus, assessed up to hospital discharge (approximately 7 days)
2

Length of hospital stay

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

Time frame
From surgery until hospital discharge (up to 30 days)
3

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

Time frame
At the beginning of surgery
4

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.

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara Etlik City Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: