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| ID | Type | Description | Link |
|---|---|---|---|
| 82345432 | Other Grant/Funding Number | Shanghai key research projects |
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In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.
This study was a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 75 years; (2) Histologically confirmed right-sided colon adenocarcinomaï¼›(3) Clinical stage I-III; (4) Performance status (ECOG) 0-1; (5) Adequate hematological, hepatic and renal function. Patients operated on as an emergency, or with tumours in the transverse colon, or with other previous malignancy within 5 years were excluded.
All particapants were recruited and randomly assigned to receive laproscopic or open right hemicoloectomy. All patients were treated with an ERAS protocol. The primary end-point was the incidence of postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification. The secondary end-points were ERAS adherence, readmissions, reoperations, hospital length of stay, mortality, and survivals. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LRH plus ERAS | Experimental | patients undergo Laparoscopic right hemicolectomy plus ERAS |
|
| ORH plus ERAS | Active Comparator | patients undergo open right hemicolectomy plus ERAS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic right hemicolectomy plus ERAS | Procedure | patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative complications | The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification | 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Time from randomization to deaths resulting from any reason | 3 years |
| disease-free survival | Time from randomization to recurrence at any site or deaths resulting from any reason |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | Time from start of incision to finish of abdomial closure | Day 1 |
| estimated blood loss | Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Jiang, MD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| Open right hemicolectomy plus ERAS | Procedure | patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs |
|
| 3 years |
| operative mortality | Deaths related to surgery within 30 days from surgery | 30 days post operatively |
| Day 1 |
| number of retrieved lymph nodes | Numbers according to the pathological report | 1 week post operatively |
| postoperative hospital stay | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge. | 30 days post operatively |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |