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

Institut Paoli-Calmettes128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

128

Conditions

Colonic Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: from hospitalization day until hospital discharge, assessed up to 15 days

Secondary Outcomes

Morbidity rate

Morbidity evaluated according Dindo-clavien classification

Time frame: 20 days post surgery

Mortality rate

Dead patient listing

Time frame: 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.

Time frame: 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).

Time frame: 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)

Time frame: 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)

Time frame: From surgery to transit recovery assessed up to 15 days

Nausea and vomiting incidence

Nausea and vomiting listing

Time frame: From surgery to hospital discharge assessed up to 15 days

Analgesic treatment incidence

Non-morphine and morphine analgesic consumption

Time frame: From surgery to 3 months post surgery

Real hospitalization duration

Real hospitalization duration (actual patient discharge date based on non-medical criteria)

Time frame: From hospitalization day until hospital discharge assessed up to 15 days

Rehospitalization number

Rehospitalization listing

Time frame: 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