Appendectomy, LaparoscopicNCT07727499

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

A study testing Laparoscopic appendectomy with 10 mmHg pneumoperitoneum and Laparoscopic appendectomy with 15 mmHg pneumoperitoneum in people with Appendectomy, Laparoscopic and Intra Abdominal Pressure, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Appendectomy, Laparoscopic, Intra Abdominal Pressure
What is being tested?: Laparoscopic appendectomy with 10 mmHg pneumoperitoneum and Laparoscopic appendectomy with 15 mmHg pneumoperitoneum
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 27 Jul 2026to 27 Oct 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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

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Patients requiring additional major abdominal procedure
Missing consent
Incomplete postoperative follow-up
Patients managed non-operatively without surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yılmaz Türk, Operator Doctor contact

+905321349903 ext. +90

yturk9@gmail.com

Turkey (Türkiye)1 site

Ankara Etlik Şehir Hastanesi
Ankara, Yenimahalle, 06170
Yılmaz Türk, Operator Doctor, +905321349903, yturk9@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions: Appendectomy, Laparoscopic, Intra Abdominal Pressure
Being tested: Laparoscopic appendectomy with 10 mmHg pneumoperitoneum, Laparoscopic appendectomy with 15 mmHg pneumoperitoneum
Keywords: pain, vas, flatus, pressure, appendicitis, intra-abdominal pressure
Medical subject headings: Pain, Flatulence, Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laparoscopic appendectomy with 10 mmHg pneumoperitoneumProcedure or surgery
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg.
Laparoscopic appendectomy with 15 mmHg pneumoperitoneumProcedure or surgery
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.

Study groups in NCT07727499
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Laparoscopic appendectomy with 15 mmHg pneumoperitoneum

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At 6 and 24 hours postoperatively

Secondary outcomes (15)

Time to first flatus
Time from completion of surgery to the first passage of flatus, recorded in hours
Measured: 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
Measured: 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
Measured: 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.
Measured: During surgery
Postoperative ileus
Incidence of postoperative ileus diagnosed according to clinical findings and need for additional management.
Measured: Within 30 days after surgery
Intra-abdominal abscess
Incidence of postoperative intra-abdominal abscess confirmed clinically and/or radiologically.
Measured: Within 30 days after surgery
Surgical site infection
Incidence of superficial or deep surgical site infection according to CDC criteria
Measured: Within 30 days after surgery
Postoperative analgesic consumption
Total postoperative analgesic requirement during the hospitalization period.
Measured: 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.
Measured: 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
Measured: During surgery
Intraoperative Complications
Incidence of intraoperative complications, including bleeding, bowel injury, vascular injury, or other procedure-related adverse events occurring during laparoscopic appendectomy
Measured: During surgery
Emergency department visit after discharge
Number of participants requiring an emergency department visit related to postoperative complications after hospital discharge
Measured: Within 30 days after surgery
Reoperation
Number of participants requiring any unplanned surgical reintervention related to postoperative complications
Measured: Within 30 days after surgery
postoperative complications
Postoperative complications occurring within 30 days after surgery will be classified according to the Clavien-Dindo classification
Measured: 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)
Measured: Immediately after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 202627 Oct 2027

First posted27 Jul 2026
Study start27 Jul 2026 (estimated)
Primary completion27 Oct 2026 (estimated)
Study completion27 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Appendectomy, LaparoscopicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Participant
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07727499
Sponsor's protocol ID: AnkaraEtlikGCYilmazTurk001
Status last verified: Jul 2026
First submitted: 9 Jul 2026
Last updated: 27 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: I can give IPD on request after submission of paper

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/

Interested in taking part?

Yılmaz Türk, Operator Doctor

+905321349903 ext. +90

yturk9@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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