Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection

Study Overview
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Brief Summary
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The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.

Official Title
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Prospective Randomized Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection

Conditions
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Colonic Disease

Intervention / Treatment
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* Procedure: Conventional pressure laparoscopy
* Procedure: Low pressure laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colic lesion justifying surgical resection by segmental colectomy, Surgery proposed by laparoscopy, Body mass index (BMI) ≤30 kg/m2, Written informed consent signed by the patient, Patient affiliated to the national French statutory healthcare insurance, system or beneficiary of this regimen. Exclusion Criteria: Probable realization of a stoma during the procedure, Robot-assisted approach, Contraindication to laparoscopic surgery, Pregnant or likely to be pregnant, Patient deprived of liberty or placed under the authority of a tutor, Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional laparoscopy<br>Laparoscopy realized at the conventional pressure (12-15 mmHg) using conventional insufflator. | Procedure: Conventional pressure laparoscopy<br>* Conventional pressure laparoscopy using conventional insufflator AirSeal®<br>|
| Experimental: Low pressure laparoscopy<br>Laparoscopy realized at low pressure (6-8mmHg) using pressure-controlled insufflator AirSeal® | Procedure: Low pressure laparoscopy<br>* Low pressure laparoscopy using pressure-controlled insufflator AirSeal®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The theoretical hospital stay | The theoretical hospital stay in days (calculated from the day of the surgery to the theoretical day of discharge according to predefined exit criteria) | from hospitalization day until hospital discharge, assessed up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rate | Morbidity evaluated according Dindo-clavien classification | 20 days post surgery | 
| Mortality rate | Dead patient listing | 20 days post surgery | 
| GastroIntestinal-Quality-of-Life Index (GIQLI) | GastroIntestinal-Quality-of-Life Index (GIQLI) questionnaire, 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144. | 20 days and 3 months post surgery | 
| Short Form Health (SF12) score | This questionnaire is an abbreviated version of the Medical Outcomes Study Short-Form General Health Survey (SF-36) contains only 12 items out of 36 with minimum score 0 (bad quality life) and maximum score at 100 (good quality life). | 20 days and 3 months post surgery | 
| Pain score using self-report pain assessment tool (EVA) | EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable) | From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery | 
| Intestinal transit recovery time frame | Period duration from surgery to intestinal gas recovery time (in days) | From surgery to transit recovery assessed up to 15 days | 
| Nausea and vomiting incidence | Nausea and vomiting listing | From surgery to hospital discharge assessed up to 15 days | 
| Analgesic treatment incidence | Non-morphine and morphine analgesic consumption | From surgery to 3 months post surgery | 
| Real hospitalization duration | Real hospitalization duration (actual patient discharge date based on non-medical criteria) | From hospitalization day until hospital discharge assessed up to 15 days | 
| Rehospitalization number | Rehospitalization listing | from hospital discharge assessed up to 15 days to 3 months post surgery | 
| Differential cost of patient care | According operating room occupation and real hospital stay | From surgery to hospital discharge assessed up to 15 days |