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

Institut Paoli-Calmettes

Status: Completed

Conditions: Colonic Disease

Treatments: Procedure: Low pressure laparoscopy; Procedure: Conventional pressure laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04112654

LOPRECOL-IPC 2017-02 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups

Conventional laparoscopy

Active Comparator group

Description:

Laparoscopy realized at the conventional pressure (12-15 mmHg) using conventional insufflator.

Treatment:

Procedure: Conventional pressure laparoscopy

Low pressure laparoscopy

Experimental group

Description:

Laparoscopy realized at low pressure (6-8mmHg) using pressure-controlled insufflator AirSeal®

Treatment:

Procedure: Low pressure laparoscopy