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

21 juli 2026 bijgewerkt door: Dr Yilmaz TURK, Ankara Etlik City Hospital

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Yılmaz Türk, Operator Doctor
  • Telefoonnummer: +90 +905321349903
  • E-mail: yturk9@gmail.com

Studie Locaties

  • Turkije (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkije (Türkiye), 06170
        • Ankara Etlik Sehir Hastanesi
        • Contact:
          • Yılmaz Türk, Operator Doctor
          • Telefoonnummer: +905321349903
          • E-mail: yturk9@gmail.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative pain (Numeric Rating Scale [NRS] 0-10)
Tijdsspanne: 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.
At 6 and 24 hours postoperatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to first flatus
Tijdsspanne: 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
From the end of surgery until first passage of flatus, assessed up to hospital discharge (approximately 7 days)
Length of hospital stay
Tijdsspanne: From surgery until hospital discharge (up to 30 days)
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
Tijdsspanne: 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
At the beginning of surgery
Need for conversion to 15 mmHg pneumoperitoneum
Tijdsspanne: 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.
During surgery
Postoperative ileus
Tijdsspanne: Within 30 days after surgery
Incidence of postoperative ileus diagnosed according to clinical findings and need for additional management.
Within 30 days after surgery
Intra-abdominal abscess
Tijdsspanne: Within 30 days after surgery
Incidence of postoperative intra-abdominal abscess confirmed clinically and/or radiologically.
Within 30 days after surgery
Surgical site infection
Tijdsspanne: Within 30 days after surgery
Incidence of superficial or deep surgical site infection according to CDC criteria
Within 30 days after surgery
Postoperative analgesic consumption
Tijdsspanne: From the end of surgery until 24 hours after surgery.
Total postoperative analgesic requirement during the hospitalization period.
From the end of surgery until 24 hours after surgery.
Surgical difficulty score
Tijdsspanne: 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.
Immediately after completion of surgery
Operation time
Tijdsspanne: During surgery
Total operative time measured from skin incision to skin closure and compared between the two pneumoperitoneum pressure groups
During surgery
Intraoperative Complications
Tijdsspanne: During surgery
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
Tijdsspanne: Within 30 days after surgery
Number of participants requiring an emergency department visit related to postoperative complications after hospital discharge
Within 30 days after surgery
Reoperation
Tijdsspanne: Within 30 days after surgery
Number of participants requiring any unplanned surgical reintervention related to postoperative complications
Within 30 days after surgery
postoperative complications
Tijdsspanne: Within 30 days after surgery
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)
Tijdsspanne: 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)
Immediately after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ankara Etlik City Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • 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/

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

27 juli 2026

Primaire voltooiing (Geschat)

27 oktober 2026

Studie voltooiing (Geschat)

27 oktober 2027

Studieregistratiedata

Eerst ingediend

9 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2026

Eerst geplaatst (Werkelijk)

27 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

21 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AnkaraEtlikGCYilmazTurk001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

I can give IPD on request after submission of paper

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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