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NCT Number: NCT05404685

Partial Nephrectomy in Low Pressure

The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.

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Key information

Conditions

Kidney Tumors Treated With Minimally Invasive Surgery Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Angers, France

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About this study

Minimally invasive route for PN is recommended to offer patients ERAS and day-case pathways leading to the best possible recovery. In this setting, pain management is crucial and every innovation supposed to offer a benefit has to be assessed. For transperitoneal laparoscopic procedures, the level and stability of the insufflation pressure will influence the quality of the pneumoperitoneum and may impact the feasibility of the surgery as well as intra and post-operative outcomes. It is universally recognized that the lower insufflation pressure, the better. However, a balance has usually to be found between technical feasibility of the surgery and lowest acceptable insufflation pressure. The AirSeal system aims to generate a stable pneumoperitoneum even in case of active gaz succion by the surgeon's assistant. The investigators then hypothesize that RAPN would be feasible and safe even in low pressure (7mm Hg) and may decrease post-operative patients' pain.

The investigators plan to describe the feasibility of Low Pressure RAPN at 7mm Hg (LP-RAPN) and assess its intra and post-operative outcomes including pain and recovery on a patient perspective. This will be achieved comparatively to RAPN performed at standard insufflation pressure of 12 mm Hg and through a single blinded randomized trial design.

The project has been developed and will be conducted within the framework of the French research network on kidney cancer UroCCR (www.uroccr.fr). INCa has been supporting this multidisciplinary network since 2011 and the web-based shared clinical and biological national database on kidney cancer UroCCR will be used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female aged of 18 and over
  • Planned transperitoneal RAPN for tumor with AirSeal system.
  • Affiliation to or beneficiary of the French social security
  • Patient in capacity and willing to accurately report pain-killer intakes in the first postoperative 7 days.
  • Free, informed and written consent signed by the patient and the investigating physician (at the latest on the day of inclusion and before any examination required by the research).

Exclusion criteria

  • Daily chronic pain-killers intake for another indication than the kidney tumor and intended to be maintained at the time of surgery
  • Person deprived of liberty
  • Person under trusteeship, curatorship or legal guardianship
  • Refusal of consent or participation in the UroCCR project and the P-NeLoP ancillary trial

Exclusion criteria

-

Treatment and study plan

Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy

Device

Use of insufflation pressure at 7 mm Hg. The groups will differ only with respect to the insufflation pressure level set on the AirSeal® system.

The level of pressure will be adjusted at the beginning of the surgery, after placement of the trocars, in accordance with the result of the randomization.

Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy

Device

Use of insufflation pressure at 12 mm Hg. The groups will differ only with respect to the insufflation pressure level set on the AirSeal® system.

The level of pressure will be adjusted at the beginning of the surgery, after placement of the trocars, in accordance with the result of the randomization.

Primary outcomes

  1. Intensity of post-operative pain

    Time frame: 24 hours after surgery

    intensity of pain measured by a numeric analogic scale (between 0 and 10)

Secondary outcomes

  1. Number of clamp procedures.

    Time frame: at surgery

    Determination of the number of off-clamp procedures and the number of on-clamp procedures (type and length of clamping)

  2. Main location and intensity of post-operative pain.

    Time frame: 6 hours and 48 hours after surgery

    Determination of main location and intensity (visual analogic scale) of post operative pain (minimum=0 correspond to worse outcome; maximum =10 correspond to better outcome)

  3. Length of surgery

    Time frame: up to 30 Days

    determination of length of surgery in minutes

  4. Estimated blood loss and intra-operative transfusion

    Time frame: at surgery

    Estimated blood loss (mL) and intra-operative transfusion

Other outcomes

  1. Plateau Pressure and PETCO2 60 minutes after incision

    Time frame: at surgery

  2. Length of Hospital stay (days)

    Time frame: up to 30 days after surgery

    Determination of Length of Hospital stay (days)

  3. Number and Clavien-Dindo classification of intra and post-operative complications up to 30 days after surgery

    Time frame: up to 30 days after surgery

  4. Pain-killer intake scoring during the first post-operative week (7days)

    Time frame: up to 7 days after surgery

  5. Minutes between end of surgery and first time out of bed

    Time frame: up to Day 2

  6. Minutes between end of surgery and resumption of feeding

    Time frame: up to Day 2 after surgery

  7. Minutes between end of surgery and resumption of bowel function (stools)

    Time frame: up to day 7 after surgery

  8. Cost difference between the two arms (€)

    Time frame: at surgery

  9. Minutes between end of surgery and resumption of bowel function (gaz)

    Time frame: up to day 2 after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal

Acronym: P-NeLoP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2022
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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