Intracorporeal Vs Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy
NCT ID: NCT03990714
Last Updated: 2019-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
168 participants
INTERVENTIONAL
2016-01-01
2018-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intracorporeal anastomosis
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.
Right hemicolectomy
It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal
Extracorporeal anastomosis
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.
Right hemicolectomy
It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal
Interventions
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Right hemicolectomy
It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Sponsor- Investigator MD Ángel Reina Duarte. HUTorrecárdenas
UNKNOWN
Sponsor-Investigator BA Francisco Rubio Gil. HU Torrecárdenas
UNKNOWN
Sponsor-Investigator MD Elisabet Vidaña Márquez. HU Torrecárdenas
UNKNOWN
Sponsor-Investigator MD Juan Manuel García Torrecillas. HU Torrecárdenas
UNKNOWN
Sponsor-Investigator Rocío Torres Fernández. HU Torrecárdenas
UNKNOWN
Sponsor-Investigator MD Almudena Moreno Serrano. Hospital Inmaculada. Huercal-Overa
UNKNOWN
Sponsor-Investigator MD Pedro Moya Forcén. HU Torrecárdenas
UNKNOWN
Sponsor-Investigator MD Jorge Alejandro Benavides Buleje. HU Reina Sofía
UNKNOWN
Hospital Universitario Torrecárdenas
OTHER
Responsible Party
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Manuel Ferrer Márquez
MD
Principal Investigators
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Manuel Ferrer-Marquez
Role: PRINCIPAL_INVESTIGATOR
Colorectal Surgeon
References
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Le 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.
Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc. 1991 Sep;1(3):144-50.
Colon 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.
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Kennedy 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.
Wu 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.
Milone 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.
Ricci 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.
Shapiro 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.
Carnuccio 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.
Morpurgo 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.
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Lee KH, Ho J, Akmal Y, Nelson R, Pigazzi A. Short- and long-term outcomes of intracorporeal versus extracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy for colon cancer. Surg Endosc. 2013 Jun;27(6):1986-90. doi: 10.1007/s00464-012-2698-1. Epub 2013 Jan 9.
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Provided Documents
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Document Type: Study Protocol
Study Documents
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Document Type: Study Protocol
A project that compares both surgical techniques in the treatment of right colon cancer and assess which is associated with a lower postoperative morbidity
View DocumentOther Identifiers
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HUTorrecardenas
Identifier Type: -
Identifier Source: org_study_id
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