Low Impact Laparoscopic in Colorectal Resection - PAROS2

Official title

Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone

Overview

To improve post-operative recovery, the concept of Low Impact Laparoscopy was developed in colo-rectal surgery with associating low-pressure pneumoperitoneum and microlaparoscopic surgery. A phase III double-blind, prospective, randomized, controlled, multi-centric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries.

Detailed description

Laparoscopy is the gold standard in colorectal surgery with many benefits in term of morbidity, post-operative pain and analgesic consumption. However the pneumoperitoneum created for the laparoscopy has several negatives impact and limits (specific pain following abdominal distension, visibility, physiological repercussion).

To improve recovery after colorectal laparoscopic surgery it was realized a first study (PAROS) which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay and decrease post-operative pain with reduction of analgesic consumption.

Minimally invasive technics like microlaparoscopic surgery, developed last years had also an impact by decreasing post operative pain. The Low Impact Laparoscopy concept was developed in colo-rectal surgery with the association of low-pressure pneumoperitoneum and microlaparoscopic surgery.

The aim of the study is to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain without taking opioids, compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries.

The design of this study is a phase III double-blind, prospective, randomized, controlled, multi-centric trial. The primary endpoint is the rate of patients with postoperative pain defined 24h after the end of the intervention by visual analog scale (VAS) ≤ 3 without taking opioids (analgesics level II or III). Secondary outcomes are operating time, conversion rate in normal pressure laparoscopy or in laparotomy, morbidity at 3 months, quality of oncological surgery, length of stay, impact of microlaparoscopic instruments of aesthetic appearance at 3 months.

The primary end point will be assessed at 24h after the end of the surgery by a blind nurse evaluating the pain intensity. After discharge of the hospital, patients will be followed with postoperative consultation at 1 month and 3 month.

Interventions

• Procedure Low pressure + microsurgical instruments
  Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
• Procedure Low pressure + standard instruments
  Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)

Primary outcome measures

• Number of patients with pain at 24 hours after the end of the intervention by NRS ≤ 3 without taking opioids (without pain reliever 2 and 3) [Time frame: At 24 hours after the end of surgery]

Secondary outcome measures (12)

• Operating time [Time frame: During surgery]
• Conversion rate in normal pressure laparoscopy and or in laparotomy [Time frame: During surgery]
• Intraoperative analgesia nociception index (ANI) [Time frame: During surgery]
• Peri-operative cardiovascular and respiratory components [Time frame: During surgery]
• Time to resume transit and gas [Time frame: An average of 5 days after the surgery]
• Number of patients with medical and/or surgical morbidity [Time frame: From the end of surgery until 3 months of follow-up]
• Number of patients with R0 resection [Time frame: During surgery]
• Number of lymph nodes examined [Time frame: During surgery]
• Length of stay in hospital [Time frame: From surgery to the end of the hospitalization (max 30 days)]
• Number of patients with pain at 30 days [Time frame: From the end of the surgery until 30 days of follow up]
• Number of patients taking analgesics until 30 days [Time frame: From the end of the surgery until 30 days of follow up]
• Impact of microsurgical instruments on the aesthetic appearance [Time frame: 30 days after surgery and 3 months of follow up]

Eligibility criteria

Inclusion criteria

• Scheduled colectomy for malignant or benign pathology
• Right colon: ileocecal resection, right colectomy, right colectomy extended to the middle of the transverse
• Left colon: sigmoidectomy, left colectomy
• Rectal resection without stoma for cancer of the upper rectum
• Patient operable by laparoscopy (classic or robot assisted for the Standard group)
• Age ≥ 18 years old
• Patient affiliated to a social security system or beneficiary of the same
• Informing the patient and obtaining free, informed and written consent, signed by the patient and his investigator

Exclusion criteria

• Laparotomy procedure
• Patients with electronic implant (ex : pacemaker)
• Total or Subtotal Colectomy
• Transverse segmental colectomy
• Left angular colectomy
• Proctectomy with stoma or Total Coloproctectomy
• Patient with stoma
• Probable realization of a stoma during the operation
• Procedure associated with colorectal surgery (except appendectomy or liver biopsy)
• Crohn's disease, Hemorrhagic Rectocolitis (UC)
• Sigmoiditis
• EVA before surgery> 3
• BMI ≥ 30
• ASA > 3
• History of laparotomy
• Emergency surgery
• Pelvic Sepsis or Preoperative Fistula
• Pregnant woman, likely to be, or breastfeeding
• Persons deprived of their liberty or under measure of judicial protection (curatorship or guardianship) or unable to give their consent
• Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

France · 3 centers

• CH de la Côte Basque — Bayonne
• CHU Bordeaux — Bordeaux
• Ch Libourne — Libourne

Publications

• Marichez A, Eude A, Martenot M, Celerier B, Capdepont M, Rullier E, Denost Q, Fernandez B. Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial. Colorectal Dis. 2023 Dec;25(12):2403-2413. doi: 10.1111/codi.16787. Epub 2023 Oct 27. PMID 37897108

Identifiers

NCT: NCT04742881 · CHUBX 2020/30

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗