Low Impact Laparoscopy for Colorectal Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.