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

Colonic Disease Clinical Trial

— LoPreCol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112654
• Other study ID #: LOPRECOL-IPC 2017-02
• Secondary ID: LOPRECOL-IPC 201
• Status: Completed
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: October 18, 2023

Study information

• Verified date: April 2024
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 18, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases

Intervention

Procedure:
• Conventional pressure laparoscopy
Conventional pressure laparoscopy using conventional insufflator AirSeal®
• Low pressure laparoscopy
Low pressure laparoscopy using pressure-controlled insufflator AirSeal®

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morbidity rate	Morbidity evaluated according Dindo-clavien classification	20 days post surgery
Secondary	Mortality rate	Dead patient listing	20 days post surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Nausea and vomiting incidence	Nausea and vomiting listing	From surgery to hospital discharge assessed up to 15 days
Secondary	Analgesic treatment incidence	Non-morphine and morphine analgesic consumption	From surgery to 3 months post surgery
Secondary	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
Secondary	Rehospitalization number	Rehospitalization listing	from hospital discharge assessed up to 15 days to 3 months post surgery
Secondary	Differential cost of patient care	According operating room occupation and real hospital stay	From surgery to hospital discharge assessed up to 15 days