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

21 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Yılmaz Türk, Operator Doctor
  • Numero di telefono: +90 +905321349903
  • Email: yturk9@gmail.com

Luoghi di studio

  • Turchia (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turchia (Türkiye), 06170
        • Ankara Etlik Sehir Hastanesi
        • Contatto:
          • Yılmaz Türk, Operator Doctor
          • Numero di telefono: +905321349903
          • Email: yturk9@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: Laparoscopic appendectomy with 10 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg.
Comparatore attivo: 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.
Procedura: Laparoscopic appendectomy with 15 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative pain (Numeric Rating Scale [NRS] 0-10)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first flatus
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within 30 days after surgery
Incidence of postoperative intra-abdominal abscess confirmed clinically and/or radiologically.
Within 30 days after surgery
Surgical site infection
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: During surgery
Total operative time measured from skin incision to skin closure and compared between the two pneumoperitoneum pressure groups
During surgery
Intraoperative Complications
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within 30 days after surgery
Number of participants requiring any unplanned surgical reintervention related to postoperative complications
Within 30 days after surgery
postoperative complications
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ankara Etlik City Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • 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/

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

27 luglio 2026

Completamento primario (Stimato)

27 ottobre 2026

Completamento dello studio (Stimato)

27 ottobre 2027

Date di iscrizione allo studio

Primo inviato

9 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2026

Primo Inserito (Effettivo)

27 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AnkaraEtlikGCYilmazTurk001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

I can give IPD on request after submission of paper

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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