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Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-II)

I

Instituto de Investigacion Sanitaria La Fe

Status and phase

Completed
Phase 4

Conditions

Laparoscopy
Colorectal Surgery

Treatments

Procedure: IPP in colorectal laparoscopic surgery
Procedure: SPP in colorectal laparoscopic surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02773173
IPPCollapse-II

Details and patient eligibility

About

The purpose of this study is to assess the post-operative recovery quality of the Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus standard therapy using a quality validated scale of postoperative recovery of their stay in the Post-Anaesthesia Recovery Unit.

Full description

In the last two decades laparoscopic surgery has settled as a less invasive surgical approach compared to open surgery. It is associated with lower perioperative morbidity and hospital stay. There is growing evidence that increased intra-abdominal pressure (IAP), even for short periods of time, is associated with increased perioperative morbidity (pain, increased inflammatory markers peritoneal injury worse splanchnic perfusion abnormalities hemodynamic and ventilatory ...).

The study is a prospective multicenter randomized clinical intervention trial to assess the impact of IAP individualization strategy (IPP-Individualized pneumoperitoneum Pressure) relative to a IAP standard strategy (SPP-Standard pneumoperitoneum Pressure) using a validated scale (VAS) (PQRS- Postoperative Quality of Recovery Scale). Postoperative pain in the first 24 hours (area under VAS curve , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/lymphocyte, ratio,C-reactive protein, interleukin-6, procalcitonin) are also measured. Postoperative complications are evaluated by Clavier-Dindo classification.

Enrollment

204 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients older than 18 years
  • Classification of the American Society of Anesthesiologists (ASA I-III)
  • No cognitive deficits
  • Signed informed consent prior to surgery

Exclusion criteria

  • Emergency surgery
  • Pregnancy or lactation
  • Immune disorders
  • Kidney or liver disease or advanced-stage cardiopulmonary
  • Patient refusal to participate in the study
  • Patients under 18 years or inability to consent
  • Associated neuromuscular disorders, contraindication for the use of rocuronium/ sugammadex, allergy or hypersensitivity to rocuronium / sugammadex

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

204 participants in 2 patient groups

Individualized Pneumoperitoneum Pressure
Experimental group
Description:
In Individualized Pneumoperitoneum Pressure (IPP) group, measures to optimize and individualize intra-abdominal pressure (PIA) will be apply.
Treatment:
Procedure: IPP in colorectal laparoscopic surgery
Standard Pneumoperitoneum Pressure
Other group
Description:
In Standard Pneumoperitoneum Pressure (SPP) group, a conventional operation without optimization measures and PIA preset to 12 mmHg will be conducted.
Treatment:
Procedure: SPP in colorectal laparoscopic surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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