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| Name | Class |
|---|---|
| Fondation de l'Avenir | OTHER |
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This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Single port surgery | Experimental | Surgery with single port |
|
| 2: Multiport surgery | Active Comparator | Surgery with multiport |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single port surgery | Procedure | Single port surgery can be converted in multiport surgery if necessary |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves PANIS, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Colorectale | Clichy | ÃŽle-de-France Region | 92110 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30303873 | Derived | Maggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003424 | Crohn Disease |
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Multiport surgery | Procedure |
|
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D000076385 | Diverticular Diseases |