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Intracorporeal Vs Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy (IVEA)

Primary Purpose

Colorectal Surgery, Anastomotic Leak, Colectomy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Right hemicolectomy
Sponsored by
Hospital Universitario Torrecárdenas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Surgery focused on measuring Right hemicolectomy, Intracorporeal anastomosis, Extracorporeal anastomosis, Laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intracorporeal anastomosis

    Extracorporeal anastomosis

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Surgical time
    o evaluate the difference in surgical time between right hemicolectomy with intracorporeal versus extracorporeal anastomosis.
    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.
    Dehiscence
    To evaluate and compare the rate of anastomotic dehiscence in both groups of anastomoses up to 30 days after surgery.
    Infection rate
    To evaluate the infection rate of the surgical site in both groups up to 30 days after surgery.
    Days of hospital stay
    o compare the difference of days of hospital stay in both groups of anastomoses.

    Full Information

    First Posted
    June 12, 2019
    Last Updated
    June 16, 2019
    Sponsor
    Hospital Universitario Torrecárdenas
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03990714
    Brief Title
    Intracorporeal Vs Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy
    Acronym
    IVEA
    Official Title
    Intracorporeal Vs Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy: a Multicenter Randomized Clinical Trial (The IVEA-study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2018 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario Torrecárdenas
    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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Surgery, Anastomotic Leak, Colectomy, Laparoscopy
    Keywords
    Right hemicolectomy, Intracorporeal anastomosis, Extracorporeal anastomosis, Laparoscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    168 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intracorporeal anastomosis
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Extracorporeal anastomosis
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Right hemicolectomy
    Intervention Description
    It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal
    Primary Outcome Measure Information:
    Title
    In patients with right colon cancer, laparoscopic right hemicolectomy with intracorporeal anastomosis presents less perioperative morbidity than extracorporeal anastomosis.
    Description
    To compare perioperative morbidity between laparoscopic right hemicolectomy with intracorporeal anastomosis versus extracorporeal anastomosis within 30 days after surgery.
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Surgical time
    Description
    o evaluate the difference in surgical time between right hemicolectomy with intracorporeal versus extracorporeal anastomosis.
    Time Frame
    4 hours
    Title
    VAS
    Description
    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.
    Time Frame
    24 hour
    Title
    Dehiscence
    Description
    To evaluate and compare the rate of anastomotic dehiscence in both groups of anastomoses up to 30 days after surgery.
    Time Frame
    30 days
    Title
    Infection rate
    Description
    To evaluate the infection rate of the surgical site in both groups up to 30 days after surgery.
    Time Frame
    30 days
    Title
    Days of hospital stay
    Description
    o compare the difference of days of hospital stay in both groups of anastomoses.
    Time Frame
    180 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manuel Ferrer-Marquez
    Organizational Affiliation
    Colorectal Surgeon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19474385
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18172729
    Citation
    Bilimoria 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.
    Results Reference
    background
    PubMed Identifier
    12885809
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    1688289
    Citation
    Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc. 1991 Sep;1(3):144-50.
    Results Reference
    background
    PubMed Identifier
    19071061
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12163961
    Citation
    Hazebroek 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.
    Results Reference
    background
    PubMed Identifier
    17634484
    Citation
    Jayne 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.
    Results Reference
    background
    PubMed Identifier
    12103285
    Citation
    Lacy 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.
    Results Reference
    background
    PubMed Identifier
    19300230
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27768552
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25414066
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27595589
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26659237
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23686680
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23627922
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23371336
    Citation
    Feroci F, Lenzi E, Garzi A, Vannucchi A, Cantafio S, Scatizzi M. Intracorporeal versus extracorporeal anastomosis after laparoscopic right hemicolectomy for cancer: a systematic review and meta-analysis. Int J Colorectal Dis. 2013 Sep;28(9):1177-86. doi: 10.1007/s00384-013-1651-7. Epub 2013 Feb 1.
    Results Reference
    background
    PubMed Identifier
    23299132
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23116767
    Citation
    Cirocchi R, Trastulli S, Farinella E, Guarino S, Desiderio J, Boselli C, Parisi A, Noya G, Slim K. Intracorporeal versus extracorporeal anastomosis during laparoscopic right hemicolectomy - systematic review and meta-analysis. Surg Oncol. 2013 Mar;22(1):1-13. doi: 10.1016/j.suronc.2012.09.002. Epub 2012 Oct 30.
    Results Reference
    background
    PubMed Identifier
    27287905
    Citation
    van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Jan;31(1):64-77. doi: 10.1007/s00464-016-4982-y. Epub 2016 Jun 10.
    Results Reference
    background
    PubMed Identifier
    23250636
    Citation
    Wong JT, Abbas MA. Laparoscopic right hemicolectomy. Tech Coloproctol. 2013 Feb;17 Suppl 1:S3-9. doi: 10.1007/s10151-012-0931-5. Epub 2012 Dec 19.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://drive.google.com/file/d/1EEFxi3XpaRW12IAzVctIrrOSo6EKi70_/view?usp=sharing
    Available IPD/Information Identifier
    Proyect
    Available IPD/Information Comments
    A project that compares both surgical techniques in the treatment of right colon cancer and assess which is associated with a lower postoperative morbidity

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    Intracorporeal Vs Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy

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