Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.

NCT03045107 | Unknown DMC

• 1 other identifier: CS 863
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However, the level of evidence coming from the currently available literature is low, based on the results of a few small and heterogeneous retrospective non-randomized studies. A randomised controlled trial is warranted to challenge these two procedures. The aim of this randomized controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right colectomy for right colon tumors.

Conditions

Colon Cancer; Anastomosis

Keywords

right colon; laparoscopic right colectomy; intracorporeal anastomosis; extracorporeal anastomosis; hospital stay; quality of life; costs

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  1 month

Secondary Outcomes (13)

• Length of incisions

  At the end of the operation

• Intraoperative complications

  intraoperatively

• Number of lymph nodes harvested

  3 weeks

• 30-day postoperative morbidity according to the Clavien-Dindo classification

  1 month

• First gas and stool passage

  1 week

Study Arms (2)

Intracorporeal ileocolic anastomosis (IIA)

EXPERIMENTAL

After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected and a side-to-side anastomosis is fashioned with a laparoscopic stapler.

Procedure: Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)

Extracorporeal ileocolic anastomosis

ACTIVE COMPARATOR

After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. Then, a primary ileocolic side-to-side handsewn or mechanical anastomosis is fashioned extracorporeally.

Procedure: Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)

Interventions

Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) PROCEDURE

After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The antimesenteric side of the stapled ends of the transverse colon and terminal ileum are approximated by a stay suture tied intracorporeally and then held by the assistant. An antimesenteric enterotomy and an antimesenteric colotomy are made about 10 cm distal to the stapled ends of the transverse colon and terminal ileum, respectively. A side-to-side anastomosis is fashioned with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The enterotomies are then closed by two layers of reabsorbable sutures tied intracorporeally. The specimen is delivered through a small Pfannenstiel or a median incision. A big dressing covering all incisions will be applied, similar to that used for the EIA group.

Intracorporeal ileocolic anastomosis (IIA)

Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) PROCEDURE

After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. A primary ileocolic side-to-side handsewn or mechanical (with GIA stapler - Covidien Medtronic) anastomosis is fashioned and the bowel returned to the abdominal cavity. After reinduction of pneumoperitoneum, the lack of twists of the ileocolic anastomosis is checked. A big dressing covering all incisions will be applied.

Extracorporeal ileocolic anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with a solitary benign or malignant neoplasm localized in the right colon
• Patients aged 18 years or older
• Patients who give written informed consent

You may not qualify if:

• acute intestinal obstruction
• colon perforation;
• liver and/or lung metastases;
• multiple primary colonic tumors;
• scheduled need for synchronous intra-abdominal surgery;
• preoperative evidence of invasion of adjacent structures, as assessed by CT or ultrasonography;
• previous ipsilateral colon surgery.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Department of Surgical Sciences, University of Torino, AOU Città della Salute e della Scienza

Torino, 10126, Italy

RECRUITING

Related Publications (11)

• Hellan M, Anderson C, Pigazzi A. Extracorporeal versus intracorporeal anastomosis for laparoscopic right hemicolectomy. JSLS. 2009 Jul-Sep;13(3):312-7.

  PMID: 19793468 RESULT

• Fabozzi M, Allieta R, Brachet Contul R, Grivon M, Millo P, Lale-Murix E, Nardi M Jr. Comparison of short- and medium-term results between laparoscopically assisted and totally laparoscopic right hemicolectomy: a case-control study. Surg Endosc. 2010 Sep;24(9):2085-91. doi: 10.1007/s00464-010-0902-8. Epub 2010 Feb 21.

  PMID: 20174945 RESULT

• Grams J, Tong W, Greenstein AJ, Salky B. Comparison of intracorporeal versus extracorporeal anastomosis in laparoscopic-assisted hemicolectomy. Surg Endosc. 2010 Aug;24(8):1886-91. doi: 10.1007/s00464-009-0865-9. Epub 2010 Jan 29.

  PMID: 20112118 RESULT

• Chaves JA, Idoate CP, Fons JB, Oliver MB, Rodriguez NP, Delgado AB, Lizoain JL. [A case-control study of extracorporeal versus intracorporeal anastomosis in patients subjected to right laparoscopic hemicolectomy]. Cir Esp. 2011 Jan;89(1):24-30. doi: 10.1016/j.ciresp.2010.10.003. Epub 2010 Dec 19. Spanish.

  PMID: 21176829 RESULT

• Roscio F, Bertoglio C, De Luca A, Frattini P, Scandroglio I. Totally laparoscopic versus laparoscopic assisted right colectomy for cancer. Int J Surg. 2012;10(6):290-5. doi: 10.1016/j.ijsu.2012.04.020. Epub 2012 May 4.

  PMID: 22564829 RESULT

• Scatizzi M, Kroning KC, Borrelli A, Andan G, Lenzi E, Feroci F. Extracorporeal versus intracorporeal anastomosis after laparoscopic right colectomy for cancer: a case-control study. World J Surg. 2010 Dec;34(12):2902-8. doi: 10.1007/s00268-010-0743-6.

  PMID: 20703468 RESULT

• 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.

  PMID: 25414066 RESULT

• Hanna MH, Hwang GS, Phelan MJ, Bui TL, Carmichael JC, Mills SD, Stamos MJ, Pigazzi A. Laparoscopic right hemicolectomy: short- and long-term outcomes of intracorporeal versus extracorporeal anastomosis. Surg Endosc. 2016 Sep;30(9):3933-42. doi: 10.1007/s00464-015-4704-x. Epub 2015 Dec 29.

  PMID: 26715015 RESULT

• 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.

  PMID: 27287905 RESULT

• Seno E, Allaix ME, Ammirati CA, Bonino MA, Arezzo A, Mistrangelo M, Morino M. Intracorporeal or extracorporeal ileocolic anastomosis after laparoscopic right colectomy: cost analysis of the Torino trial. Surg Endosc. 2023 Jan;37(1):479-485. doi: 10.1007/s00464-022-09546-7. Epub 2022 Aug 23.

  PMID: 35999317 DERIVED

• Allaix ME, Degiuli M, Bonino MA, Arezzo A, Mistrangelo M, Passera R, Morino M. Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy: A Double-blinded Randomized Controlled Trial. Ann Surg. 2019 Nov;270(5):762-767. doi: 10.1097/SLA.0000000000003519.

  PMID: 31592811 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mario Morino, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco E Allaix, MD, PhD

CONTACT

+390116335670; mallaix@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A big dressing covering all incisions will be applied at the end of each operation in both arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: February 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: July 30, 2020
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)