Hospital Universitario Virgen de La Arrixaca
Murcia, 30120, Spain
Completed
NCT Number: NCT02309931
ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
antiperistaltic side-to-side ileocecal anastomosis
ProcedureRight laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis
isoperistaltic side-to-side ileocecal anastomosis
ProcedureRight laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis
Primary outcomes
-
postoperative complications
Time frame: within the first 30 days up to one year after surgery
Number of patients with postoperative complications and grade of Clavien-Dindo
Secondary outcomes
-
Operating time
Time frame: During surgery
-
Anastomosis time
Time frame: From the enteromy to its closure.
-
Hospital length of say
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
-
first tolerance day
Time frame: 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
-
first flatus day
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
-
first faeces day
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
-
Orocecal transit
Time frame: up to one year
Using hydrogen breath test curves. preoperative, at day 2 postoperative, 1 month, 6 months and 1 year.
-
Gastrointestinal life quality
Time frame: up to one year
Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year.
Sponsors and collaborators
Lead sponsor
Hospital Universitario Virgen de la Arrixaca
Other
Registry information
Official study title
Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy for Cancer.
Acronym: ISOVANTI
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Dec 5, 2014
- Registry last updated
- Mar 7, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.