Colon CancerHEMI-D-TRENDNCT03918369
Study of the Intracorporeal Versus Extracorporeal Anastomosis in Right Hemicolectomy: HEMI-D-TREND-study
A study testing Laparoscopic right hemicolectomy with intracorporeal anastomosis. and Laparoscopic right hemicolectomy with extracorporeal anastomosis. in people with Colon Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
INTRODUCTION: Colorectal cancer is the second most frequent cancer in the Western world. Roughly a third of colorectal tumors are located in the right colon, and right hemicolectomy surgery is the treatment of choice in non-disseminated right colon cancer and other benign pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Laparoscopic right hemicolectomy with intracorporeal anastomosis. and Laparoscopic right hemicolectomy with extracorporeal anastomosis.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2019to 1 Sep 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
- Patients diagnosed with right colon neoplasia non-metastatic.
- Indication of right hemicolectomy and ileo-colic anastomosis.
- Over 18 years.
- Scheduled surgery intervened by the team of surgeons of the Coloproctology Unit of each participating hospital.
- Patients who undergone a perioperative management program corresponding to the usual practice and technique of each hospital.
Who cannot join
- Colon neoplasms from other locations.
- T4 tumor stage and stage IV of the TNM classification.
- ASA IV (American Society Anesthesiologists).
- Non-optimal nutritional status (preoperative albumin ≤3.4 g / dl).
- Do not sign informed consent.
- Pregnant patients.
Show all 9Show fewer
- Liver cirrhosis.
- Chronic renal insufficiency in dialysis treatment.
- BMI <18 and> 35 Kg / m
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Parc Tauli de Sabadell
Sabadell, Barcelona, 08208
About this study
Official title: A Multicenter Controlled Study of the Intracorporeal Mechanical Side-to-side Isoperistaltic Anastomosis Versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-study
INTRODUCTION: Colorectal cancer is the second most frequent cancer in the Western world. Roughly a third of colorectal tumors are located in the right colon, and right hemicolectomy surgery is the treatment of choice in non-disseminated right colon cancer and other benign pathologies. Despite the introduction of laparoscopy and multimodal fast-track perioperative management programs in recent years, postoperative complication rates remain high. The most serious complication is anastomotic leak (AL), which is associated with increased mortality, longer hospital stay, and reduced quality of life due to the presence of ostomies. For a long time, the importance of ileo-colic AL was underestimated. However, the ANACO study, conducted in 52 hospitals in our environment, reported a rate of AL of 8.4% with a range of 0 to 35%. This wide range is due to the differences in the surgical procedures and anastomoses used (the surgical approach may be open or laparoscopic, and the anastomosis may be manual or mechanical, with all its variations).
The results of intracorporeal laparoscopic anastomosis in the literature vary widely and, are discordant, although those reported so far estimate a DA less than 2%. But the latest publications report low rates of morbidity and of surgical space infection (SSI). The main problem with this technique is that it requires a learning curve somewhat greater than the others and its results depend on the skill of the surgeon and his casuistry. For all these reasons, it is necessary to carry out comparative studies that favor the use of this technique as gold standard.
Read more
The multicentre, controlled and randomized controlled studies have the disadvantage that randomization in centers not used with one of the techniques does include a learning curve bias. Besides the fact that in a center there is a belief that one of the techniques is superior to the other, it is not ethical to randomize the techniques. This situation has encouraged us to perform a non-randomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND).
Main objective:
To assess if laparoscopic right hemicolectomy, with anastomosis, obtains better results than laparoscopic with extracorporeal anastomosis and open surgery in terms of global morbidity, surgical space infection, anastomotic leak, re-interventions and hospital stay, in the first 30 postoperative days.
Secondary objectives:
To analyze the rate of anastomotic leak (AL) and organ-cavitary infections in each hospital.
- Compare the results obtained with those published in the literature.
- Try to identify the risk factors associated with AL.
- Analyze the comorbidities associated with the type of incision made for the extraction of the surgical piece, in intra and extracorporeal anastomosis
Read the detailed description
Study Design: TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND):
A multicenter prospective, non-randomized, controlled study of the intracorporeal mechanical side-to-side isoperistaltic anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. TREND-study.
Study procedure
Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector Extracorporeal anastomosis group according to the usual technique in each center.
Expected duration of subject participation; what is done and when: Duration of the study two years.
Population
Patients diagnosed with adenocarcinoma of the right colon up to the hepatic angle after complete colonoscopy, biopsy, and chest, abdominal and pelvic CT, and chest radiography, of the participating hospitals.
Recruitment Plan
Centers intracorporeal group: Parc Taulí University Hospital, Spain. Hospital Universitario Joan XXIII de Tarragona, Spain. Hospital de Cancer de Barretos. Brazil
Centers extracorporeal group: Consorcio Hospitalario de Terrassa (Barcelona), Spain. Hospital de Universitario de Vich (Barcelona), Spain. Hospital Universitario Arnau de Vilanova de Lleida, Spain. Hospital Santa Tecla de Tarragona, Spain. Hospital Universitario Sant Joan de Reus (Tarragona), Spain.
- Conditions
- Colon Cancer
- Being tested
- Laparoscopic right hemicolectomy with intracorporeal anastomosis., Laparoscopic right hemicolectomy with extracorporeal anastomosis.
- Keywords
- Right Colon Cancer,, Right hemicolectomy, Laparoscopic right hemicolectomy, Intracorporeal anastomosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic right hemicolectomy with intracorporeal anastomosis.Procedure or surgery
Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector
Laparoscopic right hemicolectomy with extracorporeal anastomosis.Procedure or surgery
Laparoscopic right hemicolectomy with extracorporeal anastomosis with the technical features of each center
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Intracorporeal anastomosis | Experimental | Laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. Receives: Procedure: Laparoscopic right hemicolectomy with intracorporeal anastomosis. |
| Laparoscopic extracorporeal anastomosis | Active comparator | Laparoscopic right hemicolectomy with extracorporeal anastomosis. Receives: Procedure: Laparoscopic right hemicolectomy with extracorporeal anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of anastomotic leak (AL)
Percentage of anastomic leak (defined in accordance with Peel et al.).
Measured: 30 days
Rate of global morbidity
Dindo-Clavien Classification
Measured: 30 days
Rate of Surgical site infection
SSI in accordance with the Center for Disease Control (CDC) National Nosocomial Infection Monitoring System
Measured: 30 days
Rate of Re-interventions
Percentage of re-interventions due to surgical complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start7 Mar 2019
- Primary completion31 Jul 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter prospective, non-randomized, controlled study of the intracorporeal mechanical side-to-side isoperistaltic anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. TREND-study
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Mireia Pascua-Solé, Laura Mora-Lopez, Anna Pallisera-Lloveras, Sheila Serra-Pla, Ricard Sales, Beatriz Espina, Luis Romangolo, Anna Serracant, Cristina Ruiz, Mº José Mañas Gomez, Angels Montserrat-Marti, Mireia Merichal, Carlos Cerdán-Santacruz, Antonio Sanchez, Helena Vallverdú
- Responsible party
- Principal investigator, Xavier Serra-Aracil, Corporacion Parc Tauli
- Investigators
- Xavier Serra-Aracil, MD, PhD, Principal investigator, Corporacio Parc Tauli. Parc Tauli University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918369
- Sponsor's protocol ID
- HEMI-D-TREND-2019
- Acronym
- HEMI-D-TREND
- Status last verified
- Feb 2024
- First submitted
- 15 Apr 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frasson M, Granero-Castro P, Ramos Rodriguez JL, Flor-Lorente B, Braithwaite M, Marti Martinez E, Alvarez Perez JA, Codina Cazador A, Espi A, Garcia-Granero E; ANACO Study Group. Risk factors for anastomotic leak and postoperative morbidity and mortality after elective right colectomy for cancer: results from a prospective, multicentric study of 1102 patients. Int J Colorectal Dis. 2016 Jan;31(1):105-14. doi: 10.1007/s00384-015-2376-6. Epub 2015 Aug 28.
PubMed 26315015Frasson M, Flor-Lorente B, Rodriguez JL, Granero-Castro P, Hervas D, Alvarez Rico MA, Brao MJ, Sanchez Gonzalez JM, Garcia-Granero E; ANACO Study Group. Risk Factors for Anastomotic Leak After Colon Resection for Cancer: Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients. Ann Surg. 2015 Aug;262(2):321-30. doi: 10.1097/SLA.0000000000000973.
PubMed 25361221Serra-Aracil X, Pascua-Sole M, Sanchez A, Gomez-Diaz CJ, Ruiz C, Espina B, Sierra JE, Lamas S, Vallverdu H, Corredera C, Veo C, Hoyuela C, Serracant A, Moreno F, Collera-Ormazabal P, Manas MJ, Merichal M, Cayetano-Paniagua L, Caro-Tarrago A; HEMI-D-TREND-study group. Intracorporeal vs extracorporeal anastomosis in laparoscopic right colectomy for colon cancer: a prospective multicenter cohort study (the Hemi-D-TREND study). Surg Endosc. 2026 Feb;40(2):1559-1571. doi: 10.1007/s00464-025-12401-0. Epub 2025 Dec 1.
PubMed 41326726
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Controlled Study of the Intracorporeal Mechanical Side-to-side Isoperistaltic Anastomosis Versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-study
- ClinicalTrials.gov ID
- NCT03918369
- Acronym / sponsor ID
- HEMI-D-TREND / HEMI-D-TREND-2019
- Conditions
- Colon Cancer
- Keywords
- Right Colon Cancer,, Right hemicolectomy, Laparoscopic right hemicolectomy, Intracorporeal anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Mireia Pascua-Solé, Laura Mora-Lopez, Anna Pallisera-Lloveras, Sheila Serra-Pla, Ricard Sales, Beatriz Espina, Luis Romangolo, Anna Serracant, Cristina Ruiz, Mº José Mañas Gomez, Angels Montserrat-Marti, Mireia Merichal, Carlos Cerdán-Santacruz, Antonio Sanchez, Helena Vallverdú
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 17 Apr 2019 (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.
INTRODUCTION: Colorectal cancer is the second most frequent cancer in the Western world. Roughly a third of colorectal tumors are located in the right colon, and right hemicolectomy surgery is the treatment of choice in non-disseminated right colon cancer and other benign pathologies. Despite the introduction of laparoscopy and multimodal fast-track perioperative management programs in recent years, postoperative complication rates remain high. The most serious complication is anastomotic leak (AL), which is associated with increased mortality, longer hospital stay, and reduced quality of life due to the presence of ostomies. For a long time, the importance of ileo-colic AL was underestimated. However, the ANACO study, conducted in 52 hospitals in our environment, reported a rate of AL of 8.4% with a range of 0 to 35%. This wide range is due to the differences in the surgical procedures and anastomoses used (the surgical approach may be open or laparoscopic, and the anastomosis may be manual or mechanical, with all its variations).
The results of intracorporeal laparoscopic anastomosis in the literature vary widely and, are discordant, although those reported so far estimate a DA less than 2%. But the latest publications report low rates of morbidity and of surgical space infection (SSI). The main problem with this technique is that it requires a learning curve somewhat greater than the others and its results depend on the skill of the surgeon and his casuistry. For all these reasons, it is necessary to carry out comparative studies that favor the use of this technique as gold standard.
The multicentre, controlled and randomized controlled studies have the disadvantage that randomization in centers not used with one of the techniques does include a learning curve bias. Besides the fact that in a center there is a belief that one of the techniques is superior to the other, it is not ethical to randomize the techniques. This situation has encouraged us to perform a non-randomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND).
Main objective:
To assess if laparoscopic right hemicolectomy, with anastomosis, obtains better results than laparoscopic with extracorporeal anastomosis and open surgery in terms of global morbidity, surgical space infection, anastomotic leak, re-interventions and hospital stay, in the first 30 postoperative days.
Secondary objectives:
To analyze the rate of anastomotic leak (AL) and organ-cavitary infections in each hospital.
- Compare the results obtained with those published in the literature.
- Try to identify the risk factors associated with AL.
- Analyze the comorbidities associated with the type of incision made for the extraction of the surgical piece, in intra and extracorporeal anastomosis
Detailed description
Study Design: TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND):
A multicenter prospective, non-randomized, controlled study of the intracorporeal mechanical side-to-side isoperistaltic anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. TREND-study.
Study procedure
Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector Extracorporeal anastomosis group according to the usual technique in each center.
Expected duration of subject participation; what is done and when: Duration of the study two years.
Population
Patients diagnosed with adenocarcinoma of the right colon up to the hepatic angle after complete colonoscopy, biopsy, and chest, abdominal and pelvic CT, and chest radiography, of the participating hospitals.
Recruitment Plan
Centers intracorporeal group: Parc Taulí University Hospital, Spain. Hospital Universitario Joan XXIII de Tarragona, Spain. Hospital de Cancer de Barretos. Brazil
Centers extracorporeal group: Consorcio Hospitalario de Terrassa (Barcelona), Spain. Hospital de Universitario de Vich (Barcelona), Spain. Hospital Universitario Arnau de Vilanova de Lleida, Spain. Hospital Santa Tecla de Tarragona, Spain. Hospital Universitario Sant Joan de Reus (Tarragona), Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicenter prospective, non-randomized, controlled study of the intracorporeal mechanical side-to-side isoperistaltic anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. TREND-study
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Intracorporeal anastomosis | Experimental | Procedure: Laparoscopic right hemicolectomy with intracorporeal anastomosis.Laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. |
| Laparoscopic extracorporeal anastomosis | Active comparator | Procedure: Laparoscopic right hemicolectomy with extracorporeal anastomosis.Laparoscopic right hemicolectomy with extracorporeal anastomosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with right colon neoplasia non-metastatic.
- Indication of right hemicolectomy and ileo-colic anastomosis.
- Over 18 years.
- Scheduled surgery intervened by the team of surgeons of the Coloproctology Unit of each participating hospital.
- Patients who undergone a perioperative management program corresponding to the usual practice and technique of each hospital.
Key exclusion criteria (9 listed)
- Colon neoplasms from other locations.
- T4 tumor stage and stage IV of the TNM classification.
- ASA IV (American Society Anesthesiologists).
- Non-optimal nutritional status (preoperative albumin ≤3.4 g / dl).
- Do not sign informed consent.
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 |
|---|---|---|
| Laparoscopic right hemicolectomy with intracorporeal anastomosis.Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector | Procedure or surgery | Laparoscopic Intracorporeal anastomosis |
| Laparoscopic right hemicolectomy with extracorporeal anastomosis.Laparoscopic right hemicolectomy with extracorporeal anastomosis with the technical features of each center | Procedure or surgery | Laparoscopic extracorporeal anastomosis |
Primary outcome
Percentage of anastomotic leak (AL)
Time frame: 30 days
Percentage of anastomic leak (defined in accordance with Peel et al.).
Rate of global morbidity
Time frame: 30 days
Dindo-Clavien Classification
Rate of Surgical site infection
Time frame: 30 days
SSI in accordance with the Center for Disease Control (CDC) National Nosocomial Infection Monitoring System
Rate of Re-interventions
Time frame: 30 days
Percentage of re-interventions due to surgical complications
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 Feb 2024.
- Background: PubMed 26315015Frasson M, Granero-Castro P, Ramos Rodriguez JL, Flor-Lorente B, Braithwaite M, Marti Martinez E, Alvarez Perez JA, Codina Cazador A, Espi A, Garcia-Granero E; ANACO Study Group. Risk factors for anastomotic leak and postoperative morbidity and mortality after elective right colectomy for cancer: results from a prospective, multicentric study of 1102 patients. Int J Colorectal Dis. 2016 Jan;31(1):105-14. doi: 10.1007/s00384-015-2376-6. Epub 2015 Aug 28.
- Background: PubMed 25361221Frasson M, Flor-Lorente B, Rodriguez JL, Granero-Castro P, Hervas D, Alvarez Rico MA, Brao MJ, Sanchez Gonzalez JM, Garcia-Granero E; ANACO Study Group. Risk Factors for Anastomotic Leak After Colon Resection for Cancer: Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients. Ann Surg. 2015 Aug;262(2):321-30. doi: 10.1097/SLA.0000000000000973.
- Derived from this study: PubMed 41326726Serra-Aracil X, Pascua-Sole M, Sanchez A, Gomez-Diaz CJ, Ruiz C, Espina B, Sierra JE, Lamas S, Vallverdu H, Corredera C, Veo C, Hoyuela C, Serracant A, Moreno F, Collera-Ormazabal P, Manas MJ, Merichal M, Cayetano-Paniagua L, Caro-Tarrago A; HEMI-D-TREND-study group. Intracorporeal vs extracorporeal anastomosis in laparoscopic right colectomy for colon cancer: a prospective multicenter cohort study (the Hemi-D-TREND study). Surg Endosc. 2026 Feb;40(2):1559-1571. doi: 10.1007/s00464-025-12401-0. Epub 2025 Dec 1.
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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.
Xavier Serra-Aracil, MD, PhD principal investigator
Corporacio Parc Tauli. Parc Tauli University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic right hemicolectomy with intracorporeal anastomosis. and Laparoscopic right hemicolectomy with extracorporeal anastomosis. in people with Colon Cancer, run by Corporacion Parc Tauli 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 9 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 Feb 2024. 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?
Percentage of anastomotic leak (AL) (time frame: 30 days). The study lists 4 primary outcomes in all. 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 NCT03918369, which also lists 3 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 Feb 2024.