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The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
The primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic right hemicolectomy with CME and central v | Active Comparator | laparoscopic right hemicolectomy with CME and central v |
|
| open right hemicolectomy with CME and central v | Active Comparator | open right hemicolectomy with CME and central v |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic right hemicolectomy with CME and central v | Procedure | laparoscopic right hemicolectomy with CME and central v |
|
| Measure | Description | Time Frame |
|---|---|---|
| the number of lymph nodes (LNs) harvested among both groups | the number of lymph nodes (LNs) harvested among both groups | 30 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | operative time | INTRAOPERATIVE |
| blood loss, | blood loss, | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman E Nakeeb | Mansoura University, Gastrointestinal Surgery Center | Principal Investigator |
| Mohamed E el sorogy, MD | Mansoura University, Gastrointestinal Surgery Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayman El Nakeeb | Al Mansurah | Outside U.S and Canada | 35111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25072438 | Background | Cho MS, Baek SJ, Hur H, Soh Min B, Baik SH, Kyu Kim N. Modified complete mesocolic excision with central vascular ligation for the treatment of right-sided colon cancer: long-term outcomes and prognostic factors. Ann Surg. 2015 Apr;261(4):708-15. doi: 10.1097/SLA.0000000000000831. | |
| 32172577 | Result | Vajda K, Horti I, Cserni G, Bori R, Sikorszki L. [Laparoscopic and open complete mesocolic excision in right-sided colon cancer compared with open and laparoscopic surgery]. Magy Seb. 2020 Mar;73(1):23-28. doi: 10.1556/1046.73.2020.1.3. Hungarian. |
| Label | URL |
|---|---|
| Mansoura university | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Ayman El Nakeeb | Study Protocol | View IPD |
Study Protocol
6 months
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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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Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
Not provided
Not provided
Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
|
| Open right hemicolectomy with CME and central v | Procedure | Open right hemicolectomy with CME and central v |
|
|
| post-operative complications | post-operative complications | 30 days |
| 31243573 | Result | Dewulf M, Kalmar A, Vandenberk B, Muysoms F, Defoort B, Claeys D, Pletinckx P. Complete mesocolic excision does not increase short-term complications in laparoscopic left-sided colectomies: a comparative retrospective single-center study. Langenbecks Arch Surg. 2019 Aug;404(5):557-564. doi: 10.1007/s00423-019-01797-8. Epub 2019 Jun 26. |
| 26833471 | Result | Emmanuel A, Haji A. Complete mesocolic excision and extended (D3) lymphadenectomy for colonic cancer: is it worth that extra effort? A review of the literature. Int J Colorectal Dis. 2016 Apr;31(4):797-804. doi: 10.1007/s00384-016-2502-0. Epub 2016 Jan 30. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |