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<p>Peritonectomy is a complex and time-intensive component of cytoreductive surgery (CRS) in advanced ovarian cancer. While CO₂ assisted insufflation and dissection is the concept derived from minimally invasive procedures, can potentially impact the surgical outcomes. This trial aims to evaluate the feasibility, safety, and efficacy of CO₂ Insufflation-Assisted Peritonectomy (CIAP) compared to Conventional Stripping (CS) peritonectomy.&#xa0;In this open-label, phase II randomized controlled trial, 64 patients with ovarian cancer undergoing CRS were randomized (1:1) to receive either CIAP or CS. The primary endpoint was the duration of total peritonectomy. Secondary endpoints included operative outcomes, complications, surgeon satisfaction (measured using a newly developed Surgeon Satisfaction Scale and Net Promoter Score NPS. Statistical analysis was performed using SPSS v29.0.&#xa0;CIAP significantly reduced the duration of total peritonectomy compared to CS (149 ± 9.03 vs. 190 ± 11.3&#xa0;min; <i>p</i> = 0.012). CIAP also demonstrated shorter operative times across individual regions. Postoperative morbidity and complications were comparable between groups. CIAP was rated easy to learn by 84% of surgeons and was perceived to be safe and time-saving. The Net Promoter Score for CIAP was 0.14, reflecting a modest positive inclination among operating surgeons.&#xa0;CIAP is a safe, feasible, and replicable technique that significantly reduces operative time in peritonectomy without increasing surgical morbidity. It holds promise as an adjunct in open CRS, particularly in anatomically complex or adherent regions. Larger multicentric studies are warranted to validate these findings and assess broader clinical applicability.</p>

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Feasibility, Safety, Efficacy, and Surgical Utility of CO₂ Insufflation-Assisted Peritonectomy Versus Conventional Stripping in Advanced Ovarian Cancer: an Open-Label Phase II Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2026年1月3日

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  • Nikhil Tiwari,
  • Dharma Ram Poonia,
  • Nivedita Sharma,
  • Jeewan Ram Vishnoi,
  • Lisa Chadha,
  • Richa Todi,
  • PP Sharma,
  • Sanjeev Misra

摘要

Peritonectomy is a complex and time-intensive component of cytoreductive surgery (CRS) in advanced ovarian cancer. While CO₂ assisted insufflation and dissection is the concept derived from minimally invasive procedures, can potentially impact the surgical outcomes. This trial aims to evaluate the feasibility, safety, and efficacy of CO₂ Insufflation-Assisted Peritonectomy (CIAP) compared to Conventional Stripping (CS) peritonectomy. In this open-label, phase II randomized controlled trial, 64 patients with ovarian cancer undergoing CRS were randomized (1:1) to receive either CIAP or CS. The primary endpoint was the duration of total peritonectomy. Secondary endpoints included operative outcomes, complications, surgeon satisfaction (measured using a newly developed Surgeon Satisfaction Scale and Net Promoter Score NPS. Statistical analysis was performed using SPSS v29.0. CIAP significantly reduced the duration of total peritonectomy compared to CS (149 ± 9.03 vs. 190 ± 11.3 min; p = 0.012). CIAP also demonstrated shorter operative times across individual regions. Postoperative morbidity and complications were comparable between groups. CIAP was rated easy to learn by 84% of surgeons and was perceived to be safe and time-saving. The Net Promoter Score for CIAP was 0.14, reflecting a modest positive inclination among operating surgeons. CIAP is a safe, feasible, and replicable technique that significantly reduces operative time in peritonectomy without increasing surgical morbidity. It holds promise as an adjunct in open CRS, particularly in anatomically complex or adherent regions. Larger multicentric studies are warranted to validate these findings and assess broader clinical applicability.