Low Impact Laparoscopic in Colorectal Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malignant or Benign Pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Low pressure + microsurgical instruments

Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)

Group Type EXPERIMENTAL

Low pressure + microsurgical instruments

Intervention Type PROCEDURE

Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)

Low pressure + standard instruments

Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)

Group Type ACTIVE_COMPARATOR

Low pressure + standard instruments

Intervention Type PROCEDURE

Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)

Interventions

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Low pressure + microsurgical instruments

Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)

Intervention Type PROCEDURE

Low pressure + standard instruments

Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No