An interventional study of Low pressure + microsurgical instruments and Low pressure + standard instruments in Malignant or Benign Pathology, sponsored by University Hospital, Bordeaux. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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.
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.
University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Exclusion Criteria:
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
Procedure: Low pressure + microsurgical instruments
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
Procedure: Low pressure + standard instruments
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
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)
Pain is evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)
Time frame: At 24 hours after the end of surgery
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
To analyse the cumulative morbidity at 30 days after surgery and at 3 months of follow-up according to the Clavien-DINDO classification
Time frame: From the end of surgery until 3 months of follow-up
Number of patients with R0 resection
Rate of curative surgery R0 resection for oncologic surgery
Time frame: During surgery
Number of lymph nodes examined
Number of lymph nodes examined by the pathologist for oncologic surgery
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
Pain was evaluated with the Numeric Rating Scale during hospital stay and until 30 days using a patient subject diary every day and immediately before each use of pain medication
Time frame: From the end of the surgery until 30 days of follow up
Number of patients taking analgesics until 30 days
To analyse the rate of analgesics using a patient subject diary
Time frame: From the end of the surgery until 30 days of follow up
Impact of microsurgical instruments on the aesthetic appearance
Rate of scar satisfaction at 30days and at 3 months after surgery
Time frame: 30 days after surgery and 3 months of follow up
Mean score of the EQ-5D-5L Quality of life
Health related quality of life will be assessed using the Short Form EQ-5D-5L Health Survey questionnaire. The EQ-5D-5L is a generic health status measurement instrument. It is made up of 5 questions and a visual scale. A question for each of the following aspects: mobility, the ability to wash and dress, daily activities, discomfort and pain, anxiety as well as a score for the patient's perception of the quality of life. The questionnaire is administered the day before the surgery and 1 month and 3 months after the surgery.
Time frame: From randomization until 3 months of follow up
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University Hospital, Bordeaux