CoDIG: Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

Sponsor

University Hospital of Ferrara (Other)

Overall Status

Completed

CT.gov ID

NCT03934151

Collaborator

(none)

1,225

Enrollment

Locations

9.5

Actual Duration (Months)

14.4

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to analyze the postoperative complication rate of intracorporeal versus extracorporeal anastomotic technique in laparoscopic or video assisted right hemicolectomy for malignant and benign neoplasms . The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study

Condition or Disease	Intervention/Treatment	Phase
Complication of Gastrointestinal Anastomosis Intestinal Anastomosis Complication	Procedure: intracorporeal ileocolic anastomosis Procedure: extracorporeal ileocolic anastomosis

Detailed Description

CoDIG is a cohort, observational, prospective, multi-centric national study about ileo-colic anastomosis performing with EC or IC Technique during right laparoscopic hemicolectomy.

The observational period lasts from march 2018 and September 2018. The promoter of the study is "Istituto di Chirurgia Generale 1" of Ferrara University Hospital.

135 Italian Hospitals, accredited by Health Ministry, have been contacted via e-mail and all data was compiled into a web accessible SICE database, 85 Italian clinical centres, with demonstrated experience in colorectal laparoscopic surgery, have joined the study.

Every centre was asked not to change its surgical habits concerning the technologies used, the surgical approach, the anastomotic method, the post-operative management.

Every patient involved into the study was asked to sign a consent form in order to the Helsinki Declaration.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1225 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Dec 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
intracorporeal anastomosis patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique	Procedure: intracorporeal ileocolic anastomosis laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag
extracorporeal anastomosis patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique	Procedure: extracorporeal ileocolic anastomosis ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy

Arm

Intervention/Treatment

intracorporeal anastomosis

patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique

Procedure: intracorporeal ileocolic anastomosis

laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag

extracorporeal anastomosis

patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique

Procedure: extracorporeal ileocolic anastomosis

ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy

Outcome Measures

Primary Outcome Measures

Anastomotic complications [maximum 30 days]
number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique
Postoperative day of discharge [4 to 30 days]
the lenght of stay in hospital measured in days after right hemicolectomy with ileocolic anastomosis performed with intracorporeal or extracorporeal technique

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients and/or legal guardians exhaustively informed by the investigator, and who have voluntarily provided written informed consent or, when unable to read and/or write, verbal consent put into writing by a third person
Patients who underwent elective laparoscopic or video assisted right hemicolectomy at U.O. General and Thoracic Surgery for malignant or bening pathology.
Patients who had prior chemotherapy and radiotherapy

Exclusion Criteria:

Patients operated in emergency
Pregnant women
Right laparotomic hemicolectomy
BMI> 35

Contacts and Locations

Locations

	Site	City	Country
1	ULSS5 Polesa - Ospedale di Adria	Adria	Italy
2	San Lazzaro Alba	Alba	Italy
3	Ospedale Civile L. Bonomo	Andria	Italy
4	"U.Parini" di AOsta	Aosta	Italy
5	Ospedale C e G Mazzoni	Ascoli Piceno	Italy
6	Casa di Cura Villa Maria	Avellino	Italy
7	Ospedale di Bassano del Grappa	Bassano Del Grappa	Italy
8	Policlinico San Marco	Bergamo	Italy
9	Ospedale Maggiore di Bologna	Bologna	Italy
10	SS. Pietro e Paolo	Borgosesia	Italy
11	ASST Spedali Civili	Brescia	Italy
12	Spedali Civili di Brescia Presidio Montichiari	Brescia	Italy
13	Policlinico Universitario di Monserrato - AOU Cagliari	Cagliari	Italy
14	Santissima Trinità	Cagliari	Italy
15	Aslto5 Piemonte	Chieri	Italy
16	Bassini	Cinisello Balsamo	Italy
17	U.O. Chirurgia Cles	Cles	Italy
18	Santa Maria dei Battuti	Conegliano	Italy
19	Aso Santa Croce E Carle Di Cuneo	Cuneo	Italy
20	Regina Montis Regalis Mondovì	Cuneo	Italy
21	Ospedale "E. Profili" Fabriano	Fabriano	Italy
22	Arcispedale Sant'Anna Ferrara	Ferrara	Italy
23	Istituto di chirurgia generale 1	Ferrara	Italy
24	Ospedale di Fidenza; AUSL Parma	Fidenza	Italy
25	AOU Careggi	Firenze	Italy
26	Azienda Ospedaliera Universitaria Careggi	Firenze	Italy
27	Chirurgia d' Urgenza Careggi	Firenze	Italy
28	Ospedali Riuniti di Foggia	Foggia	Italy
29	Ospedale Morgagni-Pierantoni	Forlì	Italy
30	Ospedale Policlinico San Martino	Genova	Italy
31	Chirurgia Gorizia	Gorizia	Italy
32	Gualdo Tadino	Gubbio	Italy
33	Carlo Urbani, Jesi,	Jesi	Italy
34	Ospedale Civile San Salvatore	L'Aquila	Italy
35	Ospedale Sant'Andrea	La Spezia	Italy
36	Ospedale Del Delta	Lagosanto	Italy
37	N.S. della Mercede	Lanusei	Italy
38	ICOT	Latina	Italy
39	AAS 2 "Bassa Friulana-Isontina", Ospedale di Latisana-Palmanova	Latisana	Italy
40	Policlinico G. Martino	Messina	Italy
41	"ASST NORD MILANO Ospedale Città di Sesto San Giovanni "	Milano	Italy
42	"ASST OVEST MILANESE - Ospedale G. Fornaroli Magenta "	Milano	Italy
43	ASST Grande Ospedale Metropolitano Niguarda	Milano	Italy
44	IEO (Istituto Europeo di Oncologia)	Milano	Italy
45	IRCCS Policlinico Ospedale Maggiore Milano	Milano	Italy
46	Ospedale Sacco	Milano	Italy
47	San Paolo	Milano	Italy
48	San Raffaele	Milano	Italy
49	OCSAE	Modena	Italy
50	Policlinico di Modena	Modena	Italy
51	San Valentino	Montebelluna	Italy
52	A.O.U. Federico II	Napoli	Italy
53	Int Pascale Napoli	Napoli	Italy
54	Monaldi, AORN	Napoli	Italy
55	San Francesco	Nuoro	Italy
56	Giovanni Paolo II	Olbia	Italy
57	San Luigi Gonzaga	Orbassano	Italy
58	Aoup P. Giaccone	Palermo	Italy
59	Città di Castello	Perugia	Italy
60	Ospedale Santa Maria della Misericordia	Perugia	Italy
61	Ospedale civile	Pescara	Italy
62	Pederzoli	Peschiera Del Garda	Italy
63	Ospedale Santa Corona	Pietra Ligure	Italy
64	Ospedale San Jacopo	Pistoia	Italy
65	Azienda Ospedaliera S. Maria degli Angeli	Pordenone	Italy
66	Ospedale San Tommaso dei Battuti- ULSS 4 Veneto orientale	Portogruaro	Italy
67	Santa Maria delle Croci	Ravenna	Italy
68	Chirurgia Generale	Riccione	Italy
69	Infermi	Rimini	Italy
70	Azienda Ospedaliera Sant'Andrea	Roma	Italy
71	Azienda Ospedaliera Universitaria Policlinico "Umberto I"	Roma	Italy
72	Ospedale San Camillo - Forlanini	Roma	Italy
73	ospedale San Filippo Neri Roma	Roma	Italy
74	Sant'Eugenio- Asl Roma2	Roma	Italy
75	Azienda Ospedaliera Universitaria " San Giovanni di Dio e Ruggi d'Aragona" - Università di Salerno	Salerno	Italy
76	Ospedale Nostra Signora di Bonaria	San Gavino Monreale	Italy
77	"A.O.U. Sassari "	Sassari	Italy
78	Ospedale Sassuolo SPA	Sassuolo	Italy
79	Policlinico Le Scotte	Siena	Italy
80	S. Vincenzo	Taormina	Italy
81	Citta della Salute e della Scienza di Torino sede Molinette	Torino	Italy
82	Cardinale Panico	Tricase	Italy
83	Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara	Trieste	Italy
84	Ospedale Santa Maria della Misericordia	Udine	Italy
85	Sant'Andrea	Vercelli	Italy

Sponsors and Collaborators

University Hospital of Ferrara

Investigators

Principal Investigator: Gabriele Anania, Società Italiana Chirurgia Endoscopica

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gabriele Anania, Professore Associato, University Hospital of Ferrara

ClinicalTrials.gov Identifier:

NCT03934151

Other Study ID Numbers:

170595

First Posted:

May 1, 2019

Last Update Posted:

May 1, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gabriele Anania, Professore Associato, University Hospital of Ferrara

laparoscopy

ileocolic anastomosis

right hemicolectomy

Study Results

No Results Posted as of May 1, 2019