Primary Malignant Neoplasm of Ascending ColonISOVANTINCT02309931
ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer
A study testing antiperistaltic side-to-side ileocecal anastomosis and isoperistaltic side-to-side ileocecal anastomosis in people with Primary Malignant Neoplasm of Ascending Colon, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Malignant Neoplasm of Ascending Colon
- What is being tested?
- antiperistaltic side-to-side ileocecal anastomosis and isoperistaltic side-to-side ileocecal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Pregnancy
- Intestinal bowel disease like Crohn's disease or ulcerative colitis.
- Metastatic bone illness
- Previous abdominal surgery with bowel resection
- Malabsorption syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy 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.
- Being tested
- antiperistaltic side-to-side ileocecal anastomosis, isoperistaltic side-to-side ileocecal anastomosis
- Keywords
- Right hemicolectomy, Side-to-side anastomosis, Orocecal time, Antipersitaltic, Isoperistaltic, Laparoscopic colectomy, Right laparoscopic hemicolectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiperistaltic side-to-side ileocecal anastomosisProcedure or surgery
Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis
isoperistaltic side-to-side ileocecal anastomosisProcedure or surgery
Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Isoperistaltic anastomosis | Active comparator | Patients with right colon cancer who undergo a right laparoscopic hemicolectomy and a isoperistaltic side-to-side ileocecal anastomosis Receives: Procedure: 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 Receives: Procedure: antiperistaltic side-to-side ileocecal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
Number of patients with postoperative complications and grade of Clavien-Dindo
Measured: within the first 30 days up to one year after surgery
Secondary outcomes (8)
Operating time
Measured: During surgery
Anastomosis time
Measured: From the enteromy to its closure.
Hospital length of say
Measured: 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
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
first flatus day
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
first faeces day
Measured: 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.
Measured: up to one year
Gastrointestinal life quality
Using gastrointestinal quality life index questionnaire. preoperative, 1 month, 6 months and 1 year.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJun 2014
- Primary completion1 Nov 2016
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Malignant Neoplasm of Ascending ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Abrisqueta Carrion, Hospital Universitario Virgen de la Arrixaca
- Investigators
- Juan Lujan, Ph D, Study director, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309931
- Sponsor's protocol ID
- CCR-HCUVA-2014-01
- Acronym
- ISOVANTI
- Status last verified
- Mar 2023
- First submitted
- 28 Nov 2014
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30426254Ibanez 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.
PubMed 28634703
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy for Cancer.
- ClinicalTrials.gov ID
- NCT02309931
- Acronym / sponsor ID
- ISOVANTI / CCR-HCUVA-2014-01
- Keywords
- Right hemicolectomy, Side-to-side anastomosis, Orocecal time, Antipersitaltic, Isoperistaltic, Laparoscopic colectomy, Right laparoscopic hemicolectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoperistaltic anastomosis | Active comparator | Procedure: isoperistaltic side-to-side ileocecal anastomosisPatients with right colon cancer who undergo a right laparoscopic hemicolectomy and a isoperistaltic side-to-side ileocecal anastomosis |
| Antiperistaltic anastomosis | Active comparator | Procedure: antiperistaltic side-to-side ileocecal anastomosisPatients with right colon cancer who undergo a right laparoscopic hemicolectomy and a antiperistaltic side-to-side ileocecal anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient has given informed consent to participate
- No surgery contraindications
- Elective surgery
- No pregnancy or nursery during the study
- Older than 18 years
Key exclusion criteria (5 listed)
- Pregnancy
- Intestinal bowel disease like Crohn's disease or ulcerative colitis.
- Metastatic bone illness
- Previous abdominal surgery with bowel resection
- Malabsorption syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiperistaltic side-to-side ileocecal anastomosisRight laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis | Procedure or surgery | Antiperistaltic anastomosis |
| isoperistaltic side-to-side ileocecal anastomosisRight laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis | Procedure or surgery | Isoperistaltic anastomosis |
Primary outcome
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
8 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 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
Gastrointestinal life quality
Time frame: up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 30426254Ibanez 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.
- Derived from this study: PubMed 28634703Ibanez 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Lujan, Ph D study director
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antiperistaltic side-to-side ileocecal anastomosis and isoperistaltic side-to-side ileocecal anastomosis in people with Primary Malignant Neoplasm of Ascending Colon, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: within the first 30 days up to one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02309931, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.