Single Port Colic Laparoscopic Surgery (TRUE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Colonic Neoplasms; Crohn's Disease; Diverticulitis

Treatments: Procedure: single port surgery; Procedure: Multiport surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01959087

P111112

Details and patient eligibility

About

This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.

Full description

The aim of this study is to compare surgical results of colonic resection performed by single port and multiport laparoscopic approaches. Primary endpoint is the length of postoperative hospital stay. Secondary endpoints include postoperative mortality, postoperative morbidity, conversion rates, postoperative recovery, aesthetic results, postoperative pain, and costs

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis
• Informed consent signed
• Social Insurance

Exclusion criteria

• Digestive stoma in place or planned during the intervention
• Body mass index > 30 kg/m2
• History of previous laparotomy, except Mc Burney, Pfannenstiel ou subcostal
• Subtotal colectomy
• Transverse colectomy
• Proctectomy or total coloproctectomy
• Synchronous metastasis
• Preoperative suspicion of T4 colorectal cancer
• Emergency procedure
• Associated resection (except appendectomy or liver biopsy)
• Pregnancy or current breast feeding.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

1: Single port surgery

Experimental group

Description:

Surgery with single port

Treatment:

Procedure: Multiport surgery

Procedure: single port surgery

2: Multiport surgery

Active Comparator group

Description:

Surgery with multiport

Treatment:

Procedure: Multiport surgery