NCT07727499

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jul 2026Oct 2027

First Submitted

Initial submission to the registry

July 9, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 27, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2027

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 9, 2026

Last Update Submit

July 21, 2026

Conditions

Intra Abdominal PressureAppendectomy, Laparoscopic

Keywords

painvasflatuspressureappendicitisintra-abdominal pressure

Outcome Measures

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.

    At 6 and 24 hours postoperatively

Secondary Outcomes (15)

  • Time to first flatus

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

  • Length of hospital stay

    From surgery until hospital discharge (up to 30 days)

  • Carbon dioxide (CO₂) volume required to achieve target pneumoperitoneum

    At the beginning of surgery

  • Need for conversion to 15 mmHg pneumoperitoneum

    During surgery

  • Postoperative ileus

    Within 30 days after surgery

  • +10 more secondary outcomes

Study Arms (2)

10 mmHg Pneumoperitoneum

ACTIVE COMPARATOR

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

15 mmHg Pneumoperitoneum

ACTIVE COMPARATOR

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

Interventions

Laparoscopic appendectomy with 10 mmHg pneumoperitoneumPROCEDURE

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

10 mmHg Pneumoperitoneum
Laparoscopic appendectomy with 15 mmHg pneumoperitoneumPROCEDURE

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

15 mmHg Pneumoperitoneum

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (6)

  • https://academic.oup.com/gastro/article/doi/10.1093/gastro/goae052/7717317?utm_source=chatgpt.com

    BACKGROUND

  • 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

    BACKGROUND

  • https://pubmed.ncbi.nlm.nih.gov/20306755/

    BACKGROUND

  • https://pubmed.ncbi.nlm.nih.gov/24503370/

    BACKGROUND

  • https://pubmed.ncbi.nlm.nih.gov/26275545/

    BACKGROUND

  • https://pubmed.ncbi.nlm.nih.gov/32253560/

    BACKGROUND

Related Links

MeSH Terms

Conditions

PainFlatulenceAppendicitis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Central Study Contacts

Yılmaz Türk, Operator Doctor

CONTACT

+905321349903yturk9@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Operator Doctor

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 27, 2026

Study Start

July 27, 2026

Primary Completion (Estimated)

October 27, 2026

Study Completion (Estimated)

October 27, 2027

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

I can give IPD on request after submission of paper

Locations

TU(1)