Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus standard therapy (IPPCollapse II)

Individualized Pneumoperitoneum Pressure in Colorectal laparoscopic surgery versus standard therapy (IPPCollapse II)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001693-15-ES

Enrollment

190

Registered

2016-07-15

Start date

2016-08-08

Completion date

Unknown

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumoperitoneum Pressure in Colorectal laparoscopic surgery

Interventions

Trade Name: Rocuronium Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: ROCURONIUM BROMIDE CAS Number: 119302-91-9 Other descriptive name: ROCURONIUM BROMIDE Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 95

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 (PQRS- Postoperative Quality of Recovery Scale) within 15 minutes (T15) and 40 minutes (T40) of their stay in the Post-Anaesthesia Recovery Unit and the day 1 (POD1) and day 3 (POD3) of the postoperative (POD- Postoperative Day);Secondary Objective: IAP during surgery in the individualized grup;PV0, compliance abdominal dynamic per liter and PIA max;Surgeon experience in laparoscopic surgery, cases annually, years of experience, previous experience with low IAP, Duration of surgery; Basic features of airway pressures (plateauP, peakP, pulmonary Compliance); Spontaneous / coughing movements during surgery and recruitment maneuvers; Postoperative pain in the first 24 hours (area under VAS , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/limphocite ratio, C-reactive protein, interleukin-6 and procalcitonin) in the day 1 and 3 of postoperative; Selected complications are evaluated using the scale of Clavier-Dindo; inpatient days.;Primary end point(s): Quality validated scale of postoperative recovery (PQRS- Postoperative Quality of Recovery Scale) within 15 minutes (T15) and 40 minutes (T40) of their stay in the Post-Anaesthesia Recovery Unit and the day 1 (POD1) and day 3 (POD3) of the postoperative (POD- Postoperative Day);Timepoint(s) of evaluation of this end point: The variables are collected in a standardized case report form data. PQRS is conduct baseline and after admission to PACU (postanesthesia care unit) at 15 minutes (T15) and 40 minutes (T40) and postoperatively on day 1 (POD1) and day 3 (POD3). Analytical determinations with inflammatory markers and surgical stress are performed during postoperative day 1 (POD1) and day 3 (POD3).	—

Measure

Time frame

Main Objective: 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 (PQRS- Postoperative Quality of Recovery Scale) within 15 minutes (T15) and 40 minutes (T40) of their stay in the Post-Anaesthesia Recovery Unit and the day 1 (POD1) and day 3 (POD3) of the postoperative (POD- Postoperative Day);Secondary Objective: IAP during surgery in the individualized grup;PV0, compliance abdominal dynamic per liter and PIA max;Surgeon experience in laparoscopic surgery, cases annually, years of experience, previous experience with low IAP, Duration of surgery; Basic features of airway pressures (plateauP, peakP, pulmonary Compliance); Spontaneous / coughing movements during surgery and recruitment maneuvers; Postoperative pain in the first 24 hours (area under VAS , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/limphocite ratio, C-reactive protein, interleukin-6 and procalcitonin) in the day 1 and 3 of postoperative; Selected complications are evaluated using the scale of Clavier-Dindo; inpatient days.;Primary end point(s): Quality validated scale of postoperative recovery (PQRS- Postoperative Quality of Recovery Scale) within 15 minutes (T15) and 40 minutes (T40) of their stay in the Post-Anaesthesia Recovery Unit and the day 1 (POD1) and day 3 (POD3) of the postoperative (POD- Postoperative Day);Timepoint(s) of evaluation of this end point: The variables are collected in a standardized case report form data. PQRS is conduct baseline and after admission to PACU (postanesthesia care unit) at 15 minutes (T15) and 40 minutes (T40) and postoperatively on day 1 (POD1) and day 3 (POD3). Analytical determinations with inflammatory markers and surgical stress are performed during postoperative day 1 (POD1) and day 3 (POD3).

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Secondary

Measure	Time frame
Secondary end point(s): Patients characteristics; IAP during surgery in the individualized grup; PV0, compliance abdominal dynamic per liter and PIA max; Surgeon experience in laparoscopic surgery, cases annually, years of experience, previous experience with low IAP, Duration of surgery; Basic features of airway pressures (plateauP, peakP, pulmonary Compliance); Spontaneous / coughing movements during surgery and recruitment maneuvers; Postoperative pain in the first 24 hours (area under VAS , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/limphocite ratio, C-reactive protein, interleukin-6 and procalcitonin) in the day 1 and 3 of postoperative; Selected complications are evaluated using the scale of Clavier-Dindo; inpatient days.;Timepoint(s) of evaluation of this end point: Variables are collected during surgery, in immediate postoperative and during the days 1 and 3, monitoring complications to hospital discharge.	—

Measure

Time frame

Secondary end point(s): Patients characteristics; IAP during surgery in the individualized grup; PV0, compliance abdominal dynamic per liter and PIA max; Surgeon experience in laparoscopic surgery, cases annually, years of experience, previous experience with low IAP, Duration of surgery; Basic features of airway pressures (plateauP, peakP, pulmonary Compliance); Spontaneous / coughing movements during surgery and recruitment maneuvers; Postoperative pain in the first 24 hours (area under VAS , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/limphocite ratio, C-reactive protein, interleukin-6 and procalcitonin) in the day 1 and 3 of postoperative; Selected complications are evaluated using the scale of Clavier-Dindo; inpatient days.;Timepoint(s) of evaluation of this end point: Variables are collected during surgery, in immediate postoperative and during the days 1 and 3, monitoring complications to hospital discharge.

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Countries

Spain

Contacts

Public ContactUREC

INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE

investigacion_clinica@iislafe.es34961242611

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026