Low Impact Laparoscopy for Colorectal Surgery
Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone
This study is testing if using special low-pressure tools during colorectal surgery can help patients feel less pain and recover faster compared to standard tools.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 3 sites (Bayonne and 2 other locations) |
| Trial ID | NCT04742881 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance post-operative recovery in colorectal surgery by comparing the effects of low-pressure pneumoperitoneum combined with microlaparoscopic instruments against traditional low-pressure laparoscopy using standard instruments. It is a phase III double-blind, prospective, randomized, controlled, multi-centric trial designed to assess post-operative pain levels at 24 hours post-surgery without opioid use. The study builds on previous findings that suggest low-pressure techniques can reduce pain and length of hospital stay. Participants will undergo various colorectal procedures, and their pain levels will be measured using a visual analog scale.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older scheduled for colectomy due to malignant or benign pathology.
Not a fit: Patients requiring laparotomy procedures or those with specific conditions such as Crohn's disease or electronic implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and opioid consumption for patients undergoing colorectal surgery.
How similar studies have performed: Previous studies have shown promising results with low-pressure laparoscopic techniques, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bayonne and 2 other locations
- CH de la Côte Basque — Bayonne, France (Recruiting)
- CHU Bordeaux — Bordeaux, France (Recruiting)
- Ch Libourne — Libourne, France (Recruiting)
Study contacts
- Principal investigator: Christophe LAURENT — University Hospital, Bordeaux
- Study coordinator: Christophe LAURENT
- Email: christophe.laurent@chu-bordeaux.fr
- Phone: +33 (0)5 56 79 58 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.