Colorectal SurgeryIVEANCT03990714
Intracorporeal Vs Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy
A study testing Right hemicolectomy in people with Colorectal Surgery and Anastomotic Leak, run by Hospital Universitario Torrecárdenas.
Trial summary
Objective. The aim of this study was to evaluate short-term outcomes of performing intracorporeal versus extracorporeal anastomosis in laparoscopic right hemicolectomy for right colon neoplasm. Background. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Anastomotic Leak, Colectomy
- What is being tested?
- Right hemicolectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2018
- 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
- All patients had to be 18 years of age or over, to be programmed for laparoscopic surgery for right colon neoplasm and provide a signed written consent form.
Who cannot join
- All patients who do not meet all the inclusion criteria were excluded. The other exclusion criteria included the need for emergency surgery, renal failure defined by haemodialysis, Crohn's disease, ulcerative colitis, T4 tumor invading adjacent organs, synchronous colorectal neoplasm, metastasis or carcinomatosis at diagnosis, bowel obstruction, psychiatric disorders or contraindication for laparoscopic approach.
About this study
Official title: Intracorporeal Vs Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy: a Multicenter Randomized Clinical Trial (The IVEA-study)
Objective. The aim of this study was to evaluate short-term outcomes of performing intracorporeal versus extracorporeal anastomosis in laparoscopic right hemicolectomy for right colon neoplasm. Background. Despite advances in laparoscopic approach in colorectal surgery and the clear benefit of this approach over open surgery, the technical difficulty in performing intracorporeal anastomosis causes certain groups continue performing it extracorporeally in right colon surgery.
Methods. This study was a prospective multicenter randomized trial with two parallel groups being done intracorporeal anastomosis (IA) or extracorporeal anastomosis (EA) in laparoscopic right hemicolectomy for right colon neoplasm, carried out between January 2016 and December 2018.
Read the detailed description
Right hemicolectomy using a minimally invasive technique allows for an earlier recovery, with less postoperative pain and less hospital stay. After right hemicolectomy, the ileocolic anastomosis is not performed "naturally" as is habitually done in low anterior resections or sigmoidectomies. There is, therefore, no standardization in the reconstruction technique, with two possibilities: intracorporeal and extracorporeal anastomosis.
The intracorporeal anastomosis allows proper visualization of it, ensuring adequate conformation (absence of rotation or traction), in addition allowing the closure of the mesos and avoiding the possible appearance of internal hernia, also allowing to choose the location and length of the incision necessary for the extraction of the piece. On the other hand, it is a difficult technique that requires high training in advanced laparoscopy.
The extracorporeal anastomosis is performed by extracting both ends (terminal ileum and transverse colon) through the incision through which the piece is obtained, and the anastomosis is performed. It does not require, therefore, an important training in intracorporeal sutures. On the contrary, it forces to make the abdominal incision in the area that allows the extraction of said ends. In obese patients it can be difficult since the mesos are short and do not allow their extraction easilywith ,so sometimes, it forces excessive traction. In addition, intestinal rotations during the anastomosis may go unnoticed.
Although there are currently defenders of both techniques, the extracorporeal anastomosis is currently the most performed in our environment and will be used as a reference treatment in the present study.
Numerous studies have been published comparing both techniques. A very recent meta-analysis, including 12 non-randomized comparative studies with 1492 patients, concluded that intracorporeal anastomosis is associated with less morbidity and a reduction in hospital stay, suggesting a faster recovery. To date, no well-designed, prospective, randomized and randomized study exists in the literature. We believe it is necessary, therefore, to carry out a project that compares both surgical techniques in the treatment of right colon cancer and assess which is associated with a lower postoperative morbidity.
- Conditions
- Colorectal Surgery, Anastomotic Leak, Colectomy, Laparoscopy
- Being tested
- Right hemicolectomy
- Keywords
- Right hemicolectomy, Intracorporeal anastomosis, Extracorporeal anastomosis, Laparoscopy
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right hemicolectomyProcedure or surgery
It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal anastomosis | Experimental | The specimen was preferentially extracted via a small Pfannenstiel-type incision with the protection of an Alexis Wound Protector (Applied Medical, Rancho Santa Margarita, California, USA). The incision for the extraction of the right colon is sutured in two layers by absorbable suture. The ileum was held by the assistant to prevent rotation of its mesentery. A stay suture was applied 10 cm proximal and distal to the stapled ends of the terminal ileum and colon, respectively, and then held by the assistant. An enterotomy and colotomy were made sharply at the antimesenteric corner of the staple lines. An isoperistaltic side-to-side anastomosis was fashioned with a 60-mm laparoscopic stapler. A 2-0 double-barbed suture was used to close the enterocolotomy, in two planes (the first submucosal, and the second sero-serous). The mesenteric defect and the mesocolon after the construction of either type of anastomosis were not closed. Drains were not used routinely. Receives: Procedure: Right hemicolectomy |
| Extracorporeal anastomosis | Experimental | The mobilized colon was externalized preferentially via a transverse or midline incision with the protection of an Alexis Wound Protector (Applied Medical, Rancho Santa Margarita, California, USA). A stay suture was applied 10 cm proximal and distal to the stapled ends of the terminal ileum and colon. An enterotomy and colotomy were made sharply at the antimesenteric corner of the staple lines. An isoperistaltic side-to-side anastomosis was fashioned with a 60-mm laparoscopic stapler. A 2-0 double-barbed suture was used to close the enterocolotomy, in two planes (the first submucosal, and the second sero-serous). The mesenteric defect and the mesocolon after the construction of either type of anastomosis were not closed.The incision for the extraction of the right colon and the realization of the anastomosis is sutured in two layers by absorbable suture. Drains were not used routinely. Receives: Procedure: Right hemicolectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
In patients with right colon cancer, laparoscopic right hemicolectomy with intracorporeal anastomosis presents less perioperative morbidity than extracorporeal anastomosis.
To compare perioperative morbidity between laparoscopic right hemicolectomy with intracorporeal anastomosis versus extracorporeal anastomosis within 30 days after surgery.
Measured: 24 months
Secondary outcomes (5)
Surgical time
- evaluate the difference in surgical time between right hemicolectomy with intracorporeal versus extracorporeal anastomosis.
Measured: 4 hours
VAS
Quantify, by means of the Visual-Analogue Scale (VAS: is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)), postoperative pain 24 hours after surgery and the day of hospital discharge, and determine which of the two laparoscopic right hemicolectomy techniques produces less pain.
Measured: 24 hour
Dehiscence
To evaluate and compare the rate of anastomotic dehiscence in both groups of anastomoses up to 30 days after surgery.
Measured: 30 days
Infection rate
To evaluate the infection rate of the surgical site in both groups up to 30 days after surgery.
Measured: 30 days
Days of hospital stay
- compare the difference of days of hospital stay in both groups of anastomoses.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies 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
- Model description
- The IVEA-study is a prospective multicenter randomized trial with two parallel groups being done IA or EA in laparoscopic right hemicolectomy for right colon neoplasia.
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Torrecárdenas
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor- Investigator MD Ángel Reina Duarte. HUTorrecárdenas, Sponsor-Investigator BA Francisco Rubio Gil. HU Torrecárdenas, Sponsor-Investigator MD Elisabet Vidaña Márquez. HU Torrecárdenas, Sponsor-Investigator MD Juan Manuel García Torrecillas. HU Torrecárdenas, Sponsor-Investigator Rocío Torres Fernández. HU Torrecárdenas, Sponsor-Investigator MD Almudena Moreno Serrano. Hospital Inmaculada. Huercal-Overa, Sponsor-Investigator MD Pedro Moya Forcén. HU Torrecárdenas, Sponsor-Investigator MD Jorge Alejandro Benavides Buleje. HU Reina Sofía
- Responsible party
- Principal investigator, Manuel Ferrer Márquez, Hospital Universitario Torrecárdenas
- Investigators
- Manuel Ferrer-Marquez, Principal investigator, Colorectal Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990714
- Sponsor's protocol ID
- HUTorrecardenas
- Acronym
- IVEA
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
PubMed 19474385Bilimoria KY, Palis B, Stewart AK, Bentrem DJ, Freel AC, Sigurdson ER, Talamonti MS, Ko CY. Impact of tumor location on nodal evaluation for colon cancer. Dis Colon Rectum. 2008 Feb;51(2):154-61. doi: 10.1007/s10350-007-9114-2. Epub 2008 Jan 3.
PubMed 18172729Le Voyer TE, Sigurdson ER, Hanlon AL, Mayer RJ, Macdonald JS, Catalano PJ, Haller DG. Colon cancer survival is associated with increasing number of lymph nodes analyzed: a secondary survey of intergroup trial INT-0089. J Clin Oncol. 2003 Aug 1;21(15):2912-9. doi: 10.1200/JCO.2003.05.062.
PubMed 12885809Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc. 1991 Sep;1(3):144-50.
PubMed 1688289Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.
PubMed 19071061Hazebroek EJ; Color Study Group. COLOR: a randomized clinical trial comparing laparoscopic and open resection for colon cancer. Surg Endosc. 2002 Jun;16(6):949-53. doi: 10.1007/s00464-001-8165-z. Epub 2002 Mar 18.
PubMed 12163961Jayne DG, Guillou PJ, Thorpe H, Quirke P, Copeland J, Smith AM, Heath RM, Brown JM; UK MRC CLASICC Trial Group. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol. 2007 Jul 20;25(21):3061-8. doi: 10.1200/JCO.2006.09.7758.
PubMed 17634484Lacy AM, Garcia-Valdecasas JC, Delgado S, Castells A, Taura P, Pique JM, Visa J. Laparoscopy-assisted colectomy versus open colectomy for treatment of non-metastatic colon cancer: a randomised trial. Lancet. 2002 Jun 29;359(9325):2224-9. doi: 10.1016/S0140-6736(02)09290-5.
PubMed 12103285Kennedy GD, Heise C, Rajamanickam V, Harms B, Foley EF. Laparoscopy decreases postoperative complication rates after abdominal colectomy: results from the national surgical quality improvement program. Ann Surg. 2009 Apr;249(4):596-601. doi: 10.1097/SLA.0b013e31819ec903.
PubMed 19300230Wu Q, Jin C, Hu T, Wei M, Wang Z. Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2017 Apr;27(4):348-357. doi: 10.1089/lap.2016.0485. Epub 2016 Oct 21.
PubMed 27768552Milone M, Elmore U, Di Salvo E, Delrio P, Bucci L, Ferulano GP, Napolitano C, Angiolini MR, Bracale U, Clemente M, D'ambra M, Luglio G, Musella M, Pace U, Rosati R, Milone F. Intracorporeal versus extracorporeal anastomosis. Results from a multicentre comparative study on 512 right-sided colorectal cancers. Surg Endosc. 2015 Aug;29(8):2314-20. doi: 10.1007/s00464-014-3950-7. Epub 2014 Nov 21.
PubMed 25414066Ricci C, Casadei R, Alagna V, Zani E, Taffurelli G, Pacilio CA, Minni F. A critical and comprehensive systematic review and meta-analysis of studies comparing intracorporeal and extracorporeal anastomosis in laparoscopic right hemicolectomy. Langenbecks Arch Surg. 2017 May;402(3):417-427. doi: 10.1007/s00423-016-1509-x. Epub 2016 Sep 5.
PubMed 27595589Shapiro R, Keler U, Segev L, Sarna S, Hatib K, Hazzan D. Laparoscopic right hemicolectomy with intracorporeal anastomosis: short- and long-term benefits in comparison with extracorporeal anastomosis. Surg Endosc. 2016 Sep;30(9):3823-9. doi: 10.1007/s00464-015-4684-x. Epub 2015 Dec 10.
PubMed 26659237Carnuccio P, Jimeno J, Pares D. Laparoscopic right colectomy: a systematic review and meta-analysis of observational studies comparing two types of anastomosis. Tech Coloproctol. 2014 Jan;18(1):5-12. doi: 10.1007/s10151-013-1029-4. Epub 2013 May 18.
PubMed 23686680Morpurgo E, Contardo T, Molaro R, Zerbinati A, Orsini C, D'Annibale A. Robotic-assisted intracorporeal anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy for cancer: a case control study. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):414-7. doi: 10.1089/lap.2012.0404.
PubMed 23627922
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracorporeal Vs Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy: a Multicenter Randomized Clinical Trial (The IVEA-study)
- ClinicalTrials.gov ID
- NCT03990714
- Acronym / sponsor ID
- IVEA / HUTorrecardenas
- Conditions
- Colorectal Surgery, Anastomotic Leak, Colectomy, Laparoscopy
- Keywords
- Right hemicolectomy, Intracorporeal anastomosis, Extracorporeal anastomosis, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Hospital Universitario TorrecárdenasUniversity, hospital or other
- Collaborators
- Sponsor- Investigator MD Ángel Reina Duarte. HUTorrecárdenas, Sponsor-Investigator BA Francisco Rubio Gil. HU Torrecárdenas, Sponsor-Investigator MD Elisabet Vidaña Márquez. HU Torrecárdenas, Sponsor-Investigator MD Juan Manuel García Torrecillas. HU Torrecárdenas, Sponsor-Investigator Rocío Torres Fernández. HU Torrecárdenas, Sponsor-Investigator MD Almudena Moreno Serrano. Hospital Inmaculada. Huercal-Overa, Sponsor-Investigator MD Pedro Moya Forcén. HU Torrecárdenas, Sponsor-Investigator MD Jorge Alejandro Benavides Buleje. HU Reina Sofía
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Jun 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.
Objective. The aim of this study was to evaluate short-term outcomes of performing intracorporeal versus extracorporeal anastomosis in laparoscopic right hemicolectomy for right colon neoplasm. Background. Despite advances in laparoscopic approach in colorectal surgery and the clear benefit of this approach over open surgery, the technical difficulty in performing intracorporeal anastomosis causes certain groups continue performing it extracorporeally in right colon surgery.
Methods. This study was a prospective multicenter randomized trial with two parallel groups being done intracorporeal anastomosis (IA) or extracorporeal anastomosis (EA) in laparoscopic right hemicolectomy for right colon neoplasm, carried out between January 2016 and December 2018.
Detailed description
Right hemicolectomy using a minimally invasive technique allows for an earlier recovery, with less postoperative pain and less hospital stay. After right hemicolectomy, the ileocolic anastomosis is not performed "naturally" as is habitually done in low anterior resections or sigmoidectomies. There is, therefore, no standardization in the reconstruction technique, with two possibilities: intracorporeal and extracorporeal anastomosis.
The intracorporeal anastomosis allows proper visualization of it, ensuring adequate conformation (absence of rotation or traction), in addition allowing the closure of the mesos and avoiding the possible appearance of internal hernia, also allowing to choose the location and length of the incision necessary for the extraction of the piece. On the other hand, it is a difficult technique that requires high training in advanced laparoscopy.
The extracorporeal anastomosis is performed by extracting both ends (terminal ileum and transverse colon) through the incision through which the piece is obtained, and the anastomosis is performed. It does not require, therefore, an important training in intracorporeal sutures. On the contrary, it forces to make the abdominal incision in the area that allows the extraction of said ends. In obese patients it can be difficult since the mesos are short and do not allow their extraction easilywith ,so sometimes, it forces excessive traction. In addition, intestinal rotations during the anastomosis may go unnoticed.
Although there are currently defenders of both techniques, the extracorporeal anastomosis is currently the most performed in our environment and will be used as a reference treatment in the present study.
Numerous studies have been published comparing both techniques. A very recent meta-analysis, including 12 non-randomized comparative studies with 1492 patients, concluded that intracorporeal anastomosis is associated with less morbidity and a reduction in hospital stay, suggesting a faster recovery. To date, no well-designed, prospective, randomized and randomized study exists in the literature. We believe it is necessary, therefore, to carry out a project that compares both surgical techniques in the treatment of right colon cancer and assess which is associated with a lower postoperative morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The IVEA-study is a prospective multicenter randomized trial with two parallel groups being done IA or EA in laparoscopic right hemicolectomy for right colon neoplasia.
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal anastomosis | Experimental | Procedure: Right hemicolectomyThe specimen was preferentially extracted via a small Pfannenstiel-type incision with the protection of an Alexis Wound Protector (Applied Medical, Rancho Santa Margarita, California, USA). The incision for the extraction of the right colon is sutured in two layers by absorbable suture. The ileum was held by the assistant to prevent rotation of its mesentery. A stay suture was applied 10 cm proximal and distal to the stapled ends of the terminal ileum and colon, respectively, and then held by the assistant. An enterotomy and colotomy were made sharply at the antimesenteric corner of the staple lines. An isoperistaltic side-to-side anastomosis was fashioned with a 60-mm laparoscopic stapler. A 2-0 double-barbed suture was used to close the enterocolotomy, in two planes (the first submucosal, and the second sero-serous). The mesenteric defect and the mesocolon after the construction of either type of anastomosis were not closed. Drains were not used routinely. |
| Extracorporeal anastomosis | Experimental | Procedure: Right hemicolectomyThe mobilized colon was externalized preferentially via a transverse or midline incision with the protection of an Alexis Wound Protector (Applied Medical, Rancho Santa Margarita, California, USA). A stay suture was applied 10 cm proximal and distal to the stapled ends of the terminal ileum and colon. An enterotomy and colotomy were made sharply at the antimesenteric corner of the staple lines. An isoperistaltic side-to-side anastomosis was fashioned with a 60-mm laparoscopic stapler. A 2-0 double-barbed suture was used to close the enterocolotomy, in two planes (the first submucosal, and the second sero-serous). The mesenteric defect and the mesocolon after the construction of either type of anastomosis were not closed.The incision for the extraction of the right colon and the realization of the anastomosis is sutured in two layers by absorbable suture. Drains were not used routinely. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients had to be 18 years of age or over, to be programmed for laparoscopic surgery for right colon neoplasm and provide a signed written consent form.
Key exclusion criteria (1 listed)
- All patients who do not meet all the inclusion criteria were excluded. The other exclusion criteria included the need for emergency surgery, renal failure defined by haemodialysis, Crohn's disease, ulcerative colitis, T4 tumor invading adjacent organs, synchronous colorectal neoplasm, metastasis or carcinomatosis at diagnosis, bowel obstruction, psychiatric disorders or contraindication for laparoscopic approach.
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 |
|---|---|---|
| Right hemicolectomyIt is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal | Procedure or surgery | Extracorporeal anastomosis, Intracorporeal anastomosis |
Primary outcome
In patients with right colon cancer, laparoscopic right hemicolectomy with intracorporeal anastomosis presents less perioperative morbidity than extracorporeal anastomosis.
Time frame: 24 months
To compare perioperative morbidity between laparoscopic right hemicolectomy with intracorporeal anastomosis versus extracorporeal anastomosis within 30 days after surgery.
5 secondary outcomes
Surgical time
Time frame: 4 hours
VAS
Time frame: 24 hour
Dehiscence
Time frame: 30 days
Infection rate
Time frame: 30 days
Days of hospital stay
Time frame: 180 days
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 19 Jun 2019.
- Background: PubMed 19474385Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
- Background: PubMed 18172729Bilimoria KY, Palis B, Stewart AK, Bentrem DJ, Freel AC, Sigurdson ER, Talamonti MS, Ko CY. Impact of tumor location on nodal evaluation for colon cancer. Dis Colon Rectum. 2008 Feb;51(2):154-61. doi: 10.1007/s10350-007-9114-2. Epub 2008 Jan 3.
- Background: PubMed 12885809Le Voyer TE, Sigurdson ER, Hanlon AL, Mayer RJ, Macdonald JS, Catalano PJ, Haller DG. Colon cancer survival is associated with increasing number of lymph nodes analyzed: a secondary survey of intergroup trial INT-0089. J Clin Oncol. 2003 Aug 1;21(15):2912-9. doi: 10.1200/JCO.2003.05.062.
- Background: PubMed 1688289Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc. 1991 Sep;1(3):144-50.
- Background: PubMed 19071061Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.
- Background: PubMed 12163961Hazebroek EJ; Color Study Group. COLOR: a randomized clinical trial comparing laparoscopic and open resection for colon cancer. Surg Endosc. 2002 Jun;16(6):949-53. doi: 10.1007/s00464-001-8165-z. Epub 2002 Mar 18.
- Background: PubMed 17634484Jayne DG, Guillou PJ, Thorpe H, Quirke P, Copeland J, Smith AM, Heath RM, Brown JM; UK MRC CLASICC Trial Group. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol. 2007 Jul 20;25(21):3061-8. doi: 10.1200/JCO.2006.09.7758.
- Background: PubMed 12103285Lacy AM, Garcia-Valdecasas JC, Delgado S, Castells A, Taura P, Pique JM, Visa J. Laparoscopy-assisted colectomy versus open colectomy for treatment of non-metastatic colon cancer: a randomised trial. Lancet. 2002 Jun 29;359(9325):2224-9. doi: 10.1016/S0140-6736(02)09290-5.
- Background: PubMed 19300230Kennedy GD, Heise C, Rajamanickam V, Harms B, Foley EF. Laparoscopy decreases postoperative complication rates after abdominal colectomy: results from the national surgical quality improvement program. Ann Surg. 2009 Apr;249(4):596-601. doi: 10.1097/SLA.0b013e31819ec903.
- Background: PubMed 27768552Wu Q, Jin C, Hu T, Wei M, Wang Z. Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2017 Apr;27(4):348-357. doi: 10.1089/lap.2016.0485. Epub 2016 Oct 21.
- Background: PubMed 25414066Milone M, Elmore U, Di Salvo E, Delrio P, Bucci L, Ferulano GP, Napolitano C, Angiolini MR, Bracale U, Clemente M, D'ambra M, Luglio G, Musella M, Pace U, Rosati R, Milone F. Intracorporeal versus extracorporeal anastomosis. Results from a multicentre comparative study on 512 right-sided colorectal cancers. Surg Endosc. 2015 Aug;29(8):2314-20. doi: 10.1007/s00464-014-3950-7. Epub 2014 Nov 21.
- Background: PubMed 27595589Ricci C, Casadei R, Alagna V, Zani E, Taffurelli G, Pacilio CA, Minni F. A critical and comprehensive systematic review and meta-analysis of studies comparing intracorporeal and extracorporeal anastomosis in laparoscopic right hemicolectomy. Langenbecks Arch Surg. 2017 May;402(3):417-427. doi: 10.1007/s00423-016-1509-x. Epub 2016 Sep 5.
- Individual participant dataSharing planned: No
Related trials for Colorectal Surgery
Not yet recruiting
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
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.
Manuel Ferrer-Marquez principal investigator
Colorectal Surgeon
Questions about this trial
What is this clinical trial studying?
A study testing Right hemicolectomy in people with Colorectal Surgery and Anastomotic Leak, run by Hospital Universitario Torrecárdenas.
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 1 inclusion and 1 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
In patients with right colon cancer, laparoscopic right hemicolectomy with intracorporeal anastomosis presents less perioperative morbidity than extracorporeal anastomosis. (time frame: 24 months). 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 NCT03990714, which also lists 20 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 19 Jun 2019.