Primary Malignant Neoplasm of Ascending Colon
Conditions
Keywords
Right hemicolectomy, Side-to-side anastomosis, Orocecal time, Antipersitaltic, Isoperistaltic, Laparoscopic colectomy, Right laparoscopic hemicolectomy
Brief summary
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.
Interventions
PROCEDUREantiperistaltic side-to-side ileocecal anastomosis
Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis
PROCEDUREisoperistaltic side-to-side ileocecal anastomosis
Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis
Sponsors
Hospital Universitario Virgen de la Arrixaca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Cecum, ascending, hepatic angle or transverse colon tumour confirmed by endoscopic biopsy * Radiologically resectable tumours * Absence of vascular, nervous or bone infiltration * T4 stages with near organ infiltration * Absence of peritoneal carcinomatosis * Absence of respiratory pathology that prevents for doing hydrogen breath test
Exclusion criteria
* Pregnancy * Intestinal bowel disease like Crohn's disease or ulcerative colitis. * Metastatic bone illness * Previous abdominal surgery with bowel resection * Malabsorption syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | within the first 30 days up to one year after surgery | Number of patients with postoperative complications and grade of Clavien-Dindo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anastomosis time | From the enteromy to its closure. | — |
| Hospital length of say | participants will be followed for the duration of hospital stay, an expected average of 4 days | — |
| first tolerance day | participants will be followed for the duration of hospital stay, an expected average of 4 days | First day taking liquids without vomits or abdominal distension |
| Operating time | During surgery | — |
| first faeces day | participants will be followed for the duration of hospital stay, an expected average of 4 days | — |
| Orocecal transit | up to one year | Using hydrogen breath test curves. preoperative, at day 2 postoperative, 1 month, 6 months and 1 year. |
| Gastrointestinal life quality | up to one year | Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year. |
| first flatus day | participants will be followed for the duration of hospital stay, an expected average of 4 days | — |
Countries
Spain
Outcome results
None listed