ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy for Cancer.

Conditions
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Primary Malignant Neoplasm of Ascending Colon

Intervention / Treatment
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* Procedure: antiperistaltic side-to-side ileocecal anastomosis
* Procedure: isoperistaltic side-to-side ileocecal anastomosis


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isoperistaltic anastomosis<br>Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a isoperistaltic side-to-side ileocecal anastomosis | Procedure: isoperistaltic side-to-side ileocecal anastomosis<br>* Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis<br>|
| Active Comparator: Antiperistaltic anastomosis<br>Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a antiperistaltic side-to-side ileocecal anastomosis | Procedure: antiperistaltic side-to-side ileocecal anastomosis<br>* Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time |  | During surgery | 
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right hemicolectomy, Side-to-side anastomosis, Orocecal time, Antipersitaltic, Isoperistaltic, Laparoscopic colectomy, Right laparoscopic hemicolectomy