The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery

Surgery Clinical Trial

— RECOVER  

Official title:

RECOVER Study: the Effect of Low- Versus Normal Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on the Early Quality of Recovery With Perioperative Care According to the Enhanced Recovery Principles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608436
• Other study ID #: NL65290.091.18
• Status: Completed
• Phase: Phase 4
• Start date: October 24, 2018
• Est. completion date: June 3, 2021

Study information

• Verified date: March 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery.

Description:

Rationale: the laparoscopic approach reduced trauma as compared to open surgery, however, the pressure used to create a PNP with sufficient surgical workspace still leads to significant tissue injury. Prior studies show that the use of low-pressure pneumoperitoneum (PNP) during laparoscopic surgery reduced postoperative pain scores, cumulative opioid consumption and improved bowel function recovery. Deep neuromuscular blockade (NMB) as compared to moderate NMB decreases the amount of intra-abdominal pressure required to achieve similar surgical conditions and enables the use of low-pressure PNP without compromising the quality of the surgical field and patient safety. Therefore, the use of deep NMB with low-pressure PNP could be a significant addition to the conventional Enhanced Recovery After Surgery (ERAS) protocols.

Objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery.

Study design: a multi-center, blinded, randomized controlled clinical trial.

Study population: adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis.

Intervention: participants will be randomly assigned in a 1:1 fashion to either the experimental group (group A): low pressure PNP (8 mmHg) with deep NMB (PTC 1-2) or the control group (group B): normal pressure PNP (12 mmHg) with moderate NMB (TOF count 1-2).

Primary endpoint: Quality of recovery score (QoR-40) 24 hours after surgery.

Secondary endpoints: QoR-40 score (day 3 and 7 after surgery), McGill pain- and RAND-36 score (1 day before and 3 months after surgery), pain scores, PONV, analgesia use, length of hospital stay, postoperative complications, surgical conditions and time to reach discharge criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 3, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for laparoscopic colorectal surgery with a primary anastomosis

• Obtained informed consent

• Age over 18 years

Exclusion Criteria:

• Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires

• Primary colostomy

• Neo-adjuvant chemotherapy

• Chronic use of analgesics or psychotropic drugs

• Use of NSAIDs shorter than 5 days before surgery

• Known or suspected allergy to rocuronium of sugammadex

• Neuromuscular disease

• Indication for rapid sequence induction

• Severe liver- or renal disease (creatinine clearance <30ml/min)

• BMI >35 kg/m²

• Deficiency of vitamin K dependent clotting factors or coagulopathy

Related Conditions & MeSH terms

• Neuromuscular Blockade
• Pneumoperitoneum
• Surgery

Intervention

Procedure:
• Low pressure pneumoperitoneum
Lowering intra-abdominal pressure during laparoscopic surgery

Drug:
• Rocuronium Bromide
Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block

Locations

Country	Name	City	State
Netherlands	Martini general hospital	Groningen
Netherlands	Canisius Wilhelmina Hospital	Nijmegen	Gelderland
Netherlands	Maxima Medisch Centrum	Veldhoven

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score on the Quality of Recovery-40 questionnaire	The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200.	24 hours after surgery
Secondary	Total score on the Quality of Recovery-40 questionnaire	The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200.	Day 3 and day 7 after surgery
Secondary	McGill pain Questionnaire	Validated questionnaire for the assessment of quality and intensity of pain	Upon admission and 3 months after surgery
Secondary	RAND-36 general health questionnaire	Validated patient-reported survey of health	Upon admission and 3 months after surgery
Secondary	Pain scores	Pain at rest and pain upon movement (NRS 0-10), is pain acceptable yes or no, referred shoulder pain yes or no?	1, 8, 24, and 72 hours after surgery
Secondary	Post-operative nausea and vomiting (PONV)	NRS 0-10	1, 8, 24 and 72 hours after surgery
Secondary	Cumulative use of analgesics and anti-emetics	Total dose of opiates, other analgesics and anti-emetic drugs	1, 8, 24 and 72 hours after surgery
Secondary	Length of hospital stay	Total number of days from admission to discharge after surgery (not including readmission)	From date of admission until date of discharge from the hospital (usually several days), assessed up to 3 months.
Secondary	Surgical conditions	Rating of the surgical conditions with the Leiden Surgical Rating Scale (L-SRS). The L-SRS is scored by the surgeon and ranges from 1-5 for quality of the surgical field. A score of 5 means optimal conditions: a wide laparoscopic field with no patient movements or muscle contractions, 1 means extremely poor conditions: the surgeon is unable to obtain a visible laparoscopic field because of inadequate muscle relaxation.	Intraoperative: after introduction of the trocars and every 15 minutes until the end of the pneumoperitoneum.
Secondary	Intraoperative complications	Complications during surgery graded according to the Clavien-Dindo classification	During surgery
Secondary	Postoperative complications	Postoperative complications	Up to 3 months after surgery
Secondary	Time to reach discharge criteria	Number of days to reach the following criteria after surgery: adequate pain control with oral medication, passage of flatus or defecation, intake of solid food tolerated, patient is mobilized and independent and patient accepts discharge.	From date of surgery until date of actual discharge from the hospital (usually several days), assessed up to 3 months.