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

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

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 Overview

• Status: Completed
• Conditions: Colonic Disease
• Intervention / Treatment: Procedure: Conventional pressure laparoscopy; Procedure: Low pressure laparoscopy

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bouches Du Rhone
    • Marseille, Bouches Du Rhone, France, 13009
      • Institut Paoli Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Cecile DE CHAISEMARTIN, MD, Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: LOPRECOL-IPC 2017-02 (Other Identifier: Sponsor)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No