Clinical trial NCT02309931: ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer
Official title: Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy for Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Malignant Neoplasm of Ascending Colon
Keywords: Right hemicolectomy
Side-to-side anastomosis
Orocecal time
Antipersitaltic
Isoperistaltic
Laparoscopic colectomy
Right laparoscopic hemicolectomy
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: postoperative complications
timeFrame: within the first 30 days up to one year after surgery
Secondary outcomes:
measure: Operating time
timeFrame: During surgery
measure: Anastomosis time
timeFrame: From the enteromy to its closure.
measure: Hospital length of say
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: first tolerance day
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: first flatus day
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: first faeces day
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: Orocecal transit
timeFrame: up to one year
measure: Gastrointestinal life quality
timeFrame: up to one year
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Juan Lujan, Ph D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.