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The study will provide a precise control compared to the two interventions (iso vs antiperistaltic anastomoses) with thorough measurements of the postoperative variables and complications to improve the evaluation of the surgical technique. It will also enable an evaluation of the quality of life after the procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoperistaltic anastomosis | Active Comparator | Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a isoperistaltic side-to-side ileocecal anastomosis |
|
| Antiperistaltic anastomosis | Active Comparator | Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a antiperistaltic side-to-side ileocecal anastomosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antiperistaltic side-to-side ileocecal anastomosis | Procedure | Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | Number of patients with postoperative complications and grade of Clavien-Dindo | within the first 30 days up to one year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | During surgery | |
| Anastomosis time | From the enteromy to its closure. | |
| Hospital length of say |
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Inclusion Criteria:
The patient has given informed consent to participate
No surgery contraindications
Elective surgery
No pregnancy or nursery during the study
Older than 18 years
Complete preoperative cancer staging
Tumour characteristics:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Lujan, Ph D | Hospital Universitario Virgen de la Arrixaca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de La Arrixaca | Murcia | 30120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30426254 | Derived | Ibanez N, Abrisqueta J, Lujan J, Hernandez Q, Rufete MD, Parrilla P. Isoperistaltic versus antiperistaltic ileocolic anastomosis. Does it really matter? Results from a randomised clinical trial (ISOVANTI). Surg Endosc. 2019 Sep;33(9):2850-2857. doi: 10.1007/s00464-018-6580-7. Epub 2018 Nov 13. | |
| 28634703 | Derived |
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| isoperistaltic side-to-side ileocecal anastomosis | Procedure | Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis |
|
| participants will be followed for the duration of hospital stay, an expected average of 4 days |
| first tolerance day | First day taking liquids without vomits or abdominal distension | participants will be followed for the duration of hospital stay, an expected average of 4 days |
| first flatus day | participants will be followed for the duration of hospital stay, an expected average of 4 days |
| first faeces day | participants will be followed for the duration of hospital stay, an expected average of 4 days |
| Orocecal transit | Using hydrogen breath test curves. preoperative, at day 2 postoperative, 1 month, 6 months and 1 year. | up to one year |
| Gastrointestinal life quality | Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year. | up to one year |
| Ibanez N, Abrisqueta J, Lujan J, Hernandez Q, Parrilla P. Isoperistaltic versus antiperistaltic side-to-side anastomosis after right laparoscopic hemicolectomy for cancer (ISOVANTI) trial: study protocol for a randomised clinical trial. Int J Colorectal Dis. 2017 Sep;32(9):1349-1356. doi: 10.1007/s00384-017-2840-6. Epub 2017 Jun 21. |