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

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

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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