Single Port Colic Laparoscopic Surgery

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

Detailed Description
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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

Official Title
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Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL

Conditions
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Colonic Neoplasms, Crohn's Disease, Diverticulitis

Intervention / Treatment
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* Procedure: single port surgery
* Procedure: Multiport surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Single port surgery<br>Surgery with single port | Procedure: single port surgery<br>* Single port surgery can be converted in multiport surgery if necessary<br>Procedure: Multiport surgery<br> <br> |
| Active Comparator: 2: Multiport surgery<br>Surgery with multiport | Procedure: Multiport surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay | Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative mortality | Operative mortality rate; Overall morbidity rate at 30 days postoperatively including infectious and noninfectious morbidity according to the DINDO classification; Rates of incisional herniation, occlusion, rehospitalization related to the surgical procedure and reintervention until J180; Actual hospital stay; | 30 days | 
| Post-operative morbidity |  | Day 30 | 
| Conversion rates |  | Day 1 | 
| Pathologic results |  | Day 180 | 
| Postoperative recovery |  | 30 days | 
| Postoperative pain |  | 6 days | 
| Aesthetic results |  | 180 days | 
| Costs |  | Day 180 | 
| Lenght of true hospitalization stay |  | 30 days | 
| Technical feasability |  | Day 1 | 
| Post-operative quality of life | SF-36 and GIQLI | Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single port surgery, Colonic surgery, Postoperative morbidity, Postoperative outcomes