Malignant or Benign Pathology Clinical Trial
— PAROS2Official title:
Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone
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.
| Status | Recruiting |
| Enrollment | 148 |
| Est. completion date | September 2025 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CH de la Côte Basque | Bayonne | |
| France | CHU Bordeaux | Bordeaux | |
| France | Ch Libourne | Libourne |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Bordeaux |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | At 24 hours after the end of surgery | |
| Secondary | Operating time | During surgery | ||
| Secondary | Conversion rate in normal pressure laparoscopy and or in laparotomy | During surgery | ||
| Secondary | Intraoperative analgesia nociception index (ANI) | During surgery | ||
| Secondary | Peri-operative cardiovascular and respiratory components | During surgery | ||
| Secondary | Time to resume transit and gas | An average of 5 days after the surgery | ||
| Secondary | 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 | From the end of surgery until 3 months of follow-up | |
| Secondary | Number of patients with R0 resection | Rate of curative surgery R0 resection for oncologic surgery | During surgery | |
| Secondary | Number of lymph nodes examined | Number of lymph nodes examined by the pathologist for oncologic surgery | During surgery | |
| Secondary | Length of stay in hospital | From surgery to the end of the hospitalization (max 30 days) | ||
| Secondary | 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 | From the end of the surgery until 30 days of follow up | |
| Secondary | Number of patients taking analgesics until 30 days | To analyse the rate of analgesics using a patient subject diary | From the end of the surgery until 30 days of follow up | |
| Secondary | Impact of microsurgical instruments on the aesthetic appearance | Rate of scar satisfaction at 30days and at 3 months after surgery | 30 days after surgery and 3 months of follow up | |
| Secondary | 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. | From randomization until 3 months of follow up |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03813797 -
LaPAroscopic Low pRessure cOlorectal Surgery
|
N/A |