Colon CancerNCT05446558
Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Colon Cancer and Colon Neoplasm, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA) compared to extracorporeal anastomosis (EA) are widely studied. Nowadays we can conclude, with a high level of scientific evidence, that there are a number of short-term clinical advantages of laparoscopic right colectomy with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colon Neoplasm, Malignant Neoplasm
- What is being tested?
- Intracorporeal anastomosis and Extracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2022to Jan 2023
- 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
- Neoplasms settled in the cecum, right colon, hepatic flexure or proximal transverse colon
- Surgical procedure with curative purpose.
- American Society of Anaesthesiologists Physical Status (ASA) I, II and III.
- Elective surgery.
- Signed Informed Consent.
Who cannot join
- Denial of informed consent.
- Advanced neoplasia (Stage IV)
- Urgent surgery.
- ASA IV.
- Bening colonic disease, such Ulcerative Colitis or Crohn Disease
- Multivisceral procedures performed
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Anna Sánchez López, Faculty, +34686274695, asanchezlope@santpau.cat
About this study
Official title: Long-term Clinical Results and Direct Economic Implication Within the Randomized Clinical Trial Comparing Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
Advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA) compared to extracorporeal anastomosis (EA) are widely studied. Nowadays we can conclude, with a high level of scientific evidence, that there are a number of short-term clinical advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA).
However, there is currently no randomized studies describing long-term clinical and oncological outcomes.
Read the detailed description
Background:
Little evidence has been published demonstrating the advantages of IA versus EA.
Recent publications show the superiority of IA in terms of early functional digestive recovery, a shorter surgical incision, a lower need for analgesia, lower blood loss, and lower postoperative Clavien-Dindo grade. These results are similar to other further published studies, including multicenter randomized clinical trials and meta-analyses.
Methods:
This is a a long-term clinical follow-up study of 140 patients included preaviously in the single-blind single-center randomized prospective clinical trial conducted at the Hospital de la Santa Creu i Sant Pau (HSCSP) between 2015-2018; in which 30-day clinical outcomes after laparoscopic right colectomy for colon cancer with IA vs EA anastomosis were compared.
In this new trial, prospective clinical follow-up of the included 140 patients, randomized in two groups IA and EA, will be carried out, with a minimum time of 3 years.
The main objective of the study will be:
-Comparing long-term oncological outcomes of IA vs. EA anastomosis in laparoscopic right colectomy for malignant neoplasm.
The secondary objectives will be:
- Analyzing the appearance of abdominal wall hernias and episodes of occlusion.
- Describing the direct costs of both techniques retrospectively, through the financial records of the HSCSP institution.
The main hypothesis will be:
-IA is not inferior compared to EA in terms of oncological and clinical results, with a lower rate of abdominal postoperative hernias and occlusive/subocclusive episodes.
A regular prospective clinical follow-up through periodic medical visits and complementary tests established by the criteria of the Colorectal Cancer management protocol (document agreed by the HSCSP Colorectal Tumors Committee) will be conducted.
For the economic evaluation, all direct in-hospital costs that were registered by the HSCSP management will be analysed.
Extensive written information and an informed consent about the study will be provided to the patient.
The study does not entail any risk for the patient as it does not interfere with the usual follow-up or require extraordinary complementary studies.
- Conditions
- Colon Cancer, Colon Neoplasm, Malignant Neoplasm, Colon Neoplasia, Colon Neoplasm, Malignant
- Being tested
- Intracorporeal anastomosis, Extracorporeal anastomosis
- Keywords
- anastomosis, laparoscopic right colectomy, intracorporeal, extracorporeal, intracorporeal anastomosis, extracorporeal anastomosis, randomized controlled trial, oncological outcomes, long-term follow-up, colectomy, minimally invasive surgery
- Medical subject headings
- Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal anastomosisProcedure or surgery
Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.
Device:
Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.
Extracorporeal anastomosisProcedure or surgery
A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler.
Device:
Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal anastomosis (IA) | Experimental | Experimental: Intracorporeal anastomosis Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen is retrieved through a Pfannenstiel incision. Receives: Procedure: Intracorporeal anastomosis |
| Extracorporeal anastomosis (EA) | Active comparator | A transverse incision in the right upper quadrant is performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler Receives: Procedure: Extracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed
Measured: 3 years
Secondary outcomes (10)
Disease-free survival
Percentage of patients alive without any type of recurrence (local or distant) after a 3-years follow-up-period since the laparoscopic right colectomy is performed
Measured: 3 years
Local recurrence
Percentage of patients that experiment disease recurrence which is placed in the previously operated area
Measured: 3 years
Distant recurrence
Percentage of patients that experiment disease recurrence which is placed in a different area from the previously operated region (intraperitoneal, liver, lung metastases, etc)
Measured: 3 years
Incisional hernia
Percentage of patients that present an abdominal hernia settled on any of the incisions performed during the laparoscopic right colectomy
Measured: 3 years
Intestinal obstruction
Percentage of patients that experiment mechanical impairment or complete arrest of the passage of contents through the intestine due to pathology that causes blockage of the bowel.
Measured: 3 years
Cost of surgical material
Price (in euro) of the material used in the operating room in each procedure
Measured: Intraoperative time
Cost of operative room
Price (in euro) of the total amount of hours of surgical time per each procedure
Measured: Intraoperative time
Cost per global hospitalization
Price (in euro) of the total amount of days of hospitalization per each group
Measured: Time from the first day of operation until the day that the patient is discharged from the hospital
Cost per ICU hospitalization
Price (in euro) of the total amount of days of hospitalization in Intensive Care Unit per each group
Measured: Time from the first day of entry into ICU until the day that the patient is transfered to Surgery Department
Cost of tests during hospitalization
Price (in euro) of the total amount of costs related to laboratory and diagnosis during the hospitalization period, per each group
Measured: Time from the first day of operation until the day that the patient is discharged from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start28 Feb 2022
- Primary completion28 Dec 2022 (estimated)
- Study completionJan 2023 (estimated)
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 Colon CancerStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Model description
- The study was a parallel group trial with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446558
- Sponsor's protocol ID
- IIBSP-ANA-2021-16
- Status last verified
- Oct 2022
- First submitted
- 23 May 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bollo J, Salas P, Martinez MC, Hernandez P, Rabal A, Carrillo E, Targarona E. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy assisted by laparoscopy: study protocol for a randomized controlled trial. Int J Colorectal Dis. 2018 Nov;33(11):1635-1641. doi: 10.1007/s00384-018-3157-9. Epub 2018 Sep 6.
PubMed 30191370Bollo J, Turrado V, Rabal A, Carrillo E, Gich I, Martinez MC, Hernandez P, Targarona E. Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial). Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17.
PubMed 31846067
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical Results and Direct Economic Implication Within the Randomized Clinical Trial Comparing Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
- ClinicalTrials.gov ID
- NCT05446558
- Acronym / sponsor ID
- IIBSP-ANA-2021-16
- Conditions
- Colon Cancer, Colon Neoplasm, Malignant Neoplasm, Colon Neoplasia, Colon Neoplasm, Malignant
- Keywords
- anastomosis, laparoscopic right colectomy, intracorporeal, extracorporeal, intracorporeal anastomosis, extracorporeal anastomosis, randomized controlled trial, oncological outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 6 Jul 2022 (actual)
- 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.
Advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA) compared to extracorporeal anastomosis (EA) are widely studied. Nowadays we can conclude, with a high level of scientific evidence, that there are a number of short-term clinical advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA).
However, there is currently no randomized studies describing long-term clinical and oncological outcomes.
Detailed description
Background:
Little evidence has been published demonstrating the advantages of IA versus EA.
Recent publications show the superiority of IA in terms of early functional digestive recovery, a shorter surgical incision, a lower need for analgesia, lower blood loss, and lower postoperative Clavien-Dindo grade. These results are similar to other further published studies, including multicenter randomized clinical trials and meta-analyses.
Methods:
This is a a long-term clinical follow-up study of 140 patients included preaviously in the single-blind single-center randomized prospective clinical trial conducted at the Hospital de la Santa Creu i Sant Pau (HSCSP) between 2015-2018; in which 30-day clinical outcomes after laparoscopic right colectomy for colon cancer with IA vs EA anastomosis were compared.
In this new trial, prospective clinical follow-up of the included 140 patients, randomized in two groups IA and EA, will be carried out, with a minimum time of 3 years.
The main objective of the study will be:
-Comparing long-term oncological outcomes of IA vs. EA anastomosis in laparoscopic right colectomy for malignant neoplasm.
The secondary objectives will be:
- Analyzing the appearance of abdominal wall hernias and episodes of occlusion.
- Describing the direct costs of both techniques retrospectively, through the financial records of the HSCSP institution.
The main hypothesis will be:
-IA is not inferior compared to EA in terms of oncological and clinical results, with a lower rate of abdominal postoperative hernias and occlusive/subocclusive episodes.
A regular prospective clinical follow-up through periodic medical visits and complementary tests established by the criteria of the Colorectal Cancer management protocol (document agreed by the HSCSP Colorectal Tumors Committee) will be conducted.
For the economic evaluation, all direct in-hospital costs that were registered by the HSCSP management will be analysed.
Extensive written information and an informed consent about the study will be provided to the patient.
The study does not entail any risk for the patient as it does not interfere with the usual follow-up or require extraordinary complementary studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was a parallel group trial with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal anastomosis (IA) | Experimental | Procedure: Intracorporeal anastomosisExperimental: Intracorporeal anastomosis Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen is retrieved through a Pfannenstiel incision. |
| Extracorporeal anastomosis (EA) | Active comparator | Procedure: Extracorporeal anastomosisA transverse incision in the right upper quadrant is performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neoplasms settled in the cecum, right colon, hepatic flexure or proximal transverse colon
- Surgical procedure with curative purpose.
- American Society of Anaesthesiologists Physical Status (ASA) I, II and III.
- Elective surgery.
- Signed Informed Consent.
Key exclusion criteria (6 listed)
- Denial of informed consent.
- Advanced neoplasia (Stage IV)
- Urgent surgery.
- ASA IV.
- Bening colonic disease, such Ulcerative Colitis or Crohn Disease
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 |
|---|---|---|
| Intracorporeal anastomosisIso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision. Device: Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis. | Procedure or surgery | Intracorporeal anastomosis (IA) |
| Extracorporeal anastomosisA transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler. Device: Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis. | Procedure or surgery | Extracorporeal anastomosis (EA) |
Primary outcome
Overall survival
Time frame: 3 years
Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed
10 secondary outcomes
Disease-free survival
Time frame: 3 years
Local recurrence
Time frame: 3 years
Distant recurrence
Time frame: 3 years
Incisional hernia
Time frame: 3 years
Intestinal obstruction
Time frame: 3 years
Cost of surgical material
Time frame: Intraoperative time
Cost of operative room
Time frame: Intraoperative time
Cost per global hospitalization
Time frame: Time from the first day of operation until the day that the patient is discharged from the hospital
Cost per ICU hospitalization
Time frame: Time from the first day of entry into ICU until the day that the patient is transfered to Surgery Department
Cost of tests during hospitalization
Time frame: Time from the first day of operation until the day that the patient is discharged from the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Background: PubMed 30191370Bollo J, Salas P, Martinez MC, Hernandez P, Rabal A, Carrillo E, Targarona E. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy assisted by laparoscopy: study protocol for a randomized controlled trial. Int J Colorectal Dis. 2018 Nov;33(11):1635-1641. doi: 10.1007/s00384-018-3157-9. Epub 2018 Sep 6.
- Background: PubMed 31846067Bollo J, Turrado V, Rabal A, Carrillo E, Gich I, Martinez MC, Hernandez P, Targarona E. Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial). Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Colon Cancer and Colon Neoplasm, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Sánchez López (+34686274695, asanchezlope@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). 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 NCT05446558, 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 31 Oct 2022.