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

2026年7月21日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Yılmaz Türk, Operator Doctor
  • 電話番号：+90 +905321349903
  • メール：yturk9@gmail.com

研究場所

  • トルコ（Türkiye）
    • Yenimahalle
      • Ankara、Yenimahalle、トルコ（Türkiye）、06170
        • Ankara Etlik Sehir Hastanesi
        • コンタクト：
          • Yılmaz Türk, Operator Doctor
          • 電話番号：+905321349903
          • メール：yturk9@gmail.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
手順：Laparoscopic appendectomy with 10 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 10 mmHg.
アクティブコンパレータ：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.
手順：Laparoscopic appendectomy with 15 mmHg pneumoperitoneum
Laparoscopic appendectomy performed using an intra-abdominal pneumoperitoneum pressure of 15 mmHg.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Postoperative pain (Numeric Rating Scale [NRS] 0-10)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to first flatus
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Within 30 days after surgery
Incidence of postoperative intra-abdominal abscess confirmed clinically and/or radiologically.
Within 30 days after surgery
Surgical site infection
時間枠：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
時間枠：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
時間枠：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
時間枠：During surgery
Total operative time measured from skin incision to skin closure and compared between the two pneumoperitoneum pressure groups
During surgery
Intraoperative Complications
時間枠：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
時間枠：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
時間枠：Within 30 days after surgery
Number of participants requiring any unplanned surgical reintervention related to postoperative complications
Within 30 days after surgery
postoperative complications
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ankara Etlik City Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

  • 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/

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月27日

一次修了 (推定)

2026年10月27日

研究の完了 (推定)

2027年10月27日

試験登録日

最初に提出

2026年7月9日

QC基準を満たした最初の提出物

2026年7月21日

最初の投稿 (実際)

2026年7月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月27日

QC基準を満たした最後の更新が送信されました

2026年7月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AnkaraEtlikGCYilmazTurk001

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

I can give IPD on request after submission of paper

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