INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer

Colorectal Cancer Clinical Trial

— INEXTREMO  

Official title:

INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer: a Randomized Clinical Trial. (IN EXTREMO Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01679756
• Other study ID #: EAES 7625
• Status: Not yet recruiting
• Phase: N/A
• First received: September 1, 2012
• Last updated: September 1, 2012
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2012
• Source: Ospedale Misericordia e Dolce
• Contact: Francesco Feroci, MD
• Phone: +393398382381
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal anastomosis (EA) after laparoscopic right hemicolectomy for cancer.

Description:

Background. Only a few retrospective publications comparing these anastomotic techniques and no randomized clinical trial has been performed. We conducted a meta-analysis of the existing non randomized comparative studies on the argument: the results suggest that the IA results in better postoperative recovery outcomes, such as shorter hospital stay, faster bowel movement recovery, faster first flatus, faster time to solid diet and lesser analgesic usage.

Design: Two-armed, double-blinded, randomized, controlled study.

The patients will be randomized into two groups:

A. After laparoscopic right colectomy for cancer, anastomosis will be carried out intracorporeally (IA) B. After laparoscopic right colectomy for cancer, anastomosis will be carried out extracorporeally (EA)

Primary endpoint: Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.

Secondary endpoints:

• Intra-operative: operative time, largest incision length (mm), number of nodes harvested, intraoperative complications.

• Early postoperative: mortality, non-surgical site complications.

• Postoperative recovery: bowel movement, first flatus, time to solid diet, nasogastric tube (NGT) reintroduction, day of analgesic usage, length of stay, readmission.

Randomization. The randomization will be obtained through a computer generated program (GraphPad Software, Inc, La Jolla, California, USA). The randomization, will be done before the beginning of the study and it will consist with an ordered series of numbers with a corresponding letter: A for intracorporeal anastomosis and B for extracorporeal anastomosis. This series of numbers will be kept in a central dedicated web database; after right colon cancer diagnosis, if the patient fulfills the inclusion criteria and signs the consent a number, progressive as in order of inclusion, will be assigned to him or her. The letter corresponding to the number, and hence the type of procedure to perform, will be notified to the operating surgeon, who will proceed accordingly.

Blinding. A second surgeon team (different from the one who participate in the intervention), aware of the operative findings but not the management of the anastomosis, will then assume the care of the patient. Postoperative care and ability to be discharged from the hospital will be determined by the second surgical team. This second surgical team will be blinded to the kind of anastomosis. The primary operative team will be in every moment available for emergent consultation.

Power Calculation. The reported prevalence of surgical morbidity after laparoscopic colectomy varies widely from 5-15%16-39, usually depending on the definition of complications and the type of resection performed. The most recent Cochrane review on the argument indicates a 8.6% of local morbidity (Wound infection, anastomotic insufficiency, postoperative ileus, postoperative bleeding)40. Therefore the number of patients required was based on the hope of improving the rate of surgical morbidity from 8.6% to 4.3%; considering a drop-out rate of 5%, 384 patients (192 in the IA group and 192 in the EA group) are necessary to ensure an 80% power with an alpha of 5%, when using a two-sided log-rank test. The statistical power sample calculation was carried out using PASS 2005 (Power Analysis and Sample Size, within the statistical package "NCSS 2004 and PASS 2005").

Sixty-four patients will be included by each of the six centers of the consortium. Only surgeons with at least 30 right colectomies performed with intracorporeal anastomosis will be allowed to recruit patients as first operator.

Statistics. To evaluate significance of differences between the two groups, chi-squared and Fisher's exact test will be used as appropriated for categorical variables, and the non-parametric Mann-Whitney U-test for continuous variables. Significance level will be set at 5%. The statistical analysis will be carried out using the Statistical Package for the Social Sciences (SPSS version 13; SPSS Inc. Chicago, Illinois, USA).

Monitoring. as commonly requested for Randomized Controlled Trials on patients, a strict control of outcomes has been planned during the study. Three experts in laparoscopic colorectal surgery will be designed as member of IN EXTREMO Trial Monitoring Committee. They would have access to the data during the whole course of the study and indicate cessation of the trial if one arm is providing manifestly inferior results.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 384
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

• Patients suitable for curative surgery 18-80 years old

• ASA grade I-III

• Histhopatological confirmed right only colon carcinoma.

• Elective interventions

• Laparoscopic surgery

• Informed consent

Exclusion criteria

• Informed consent refusal

• Metastatic disease

• Not right colon cancer

• Non elective procedure

• Open or converted operations

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Laparoscopic right hemicolectomy for cancer
After induction of anesthesia, a foley catheter and an NG tube will be inserted. All patients will have their NG tubes removed after the procedure. During the procedure patients will be placed in Trendelenburg position with 15 degrees of tilt and with a right side up (tilt to the left of 25 degrees). A Veres needle will be inserted and pneumoperitoneum induced and maintained at 12 mmHg for the entire duration of the procedure. Under direct vision, three 10-12mm trocars will be inserted in the left abdominal wall. The ileocolic vessels, the right colic vessels (when present), the right branch of the middle colic vessels and the right gastroepiploic vessels will be ligated intracorporeally at their origin using clips. Anastomosis are described in each arm description.

Locations

Country	Name	City	State
Italy	Misericordia e Dolce Hospital	Prato	Po

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Scatizzi M, Kröning 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall surgical morbidity	Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.	60 days from surgery	Yes
Secondary	Operative time	Minutes from skin incision to skin closure	day of intervention	No
Secondary	Largest incision length	millimeters of skin incision	day of intervention	No
Secondary	Numbers of node harvested	Numbers of node harvested	day of intervention	No
Secondary	Intraoperative complicatons	Incidence and kind of intraoperative morbidity	day of intervention	Yes
Secondary	Mortality	Incidence and kind of intraoperative morbidity	60 days from surgery	Yes
Secondary	Non surgical site complications	Incidence and kind of medical morbidity (cardiovascular, respiratory, or metabolic events; nonsurgical infections; deep venous thrombosis; and pulmonary embolism)	60 days from surgery	Yes
Secondary	Bowel movement	Defined as hours from surgery to peristalsis, assessement every 8 hours	10 days from surgery	No
Secondary	First flatus	Defined as hours from surgery to first flatus	10 days from surgery	No
Secondary	First stool canalization	Defined as hours from surgery to first stool canalization	10 days from surgery	No
Secondary	Time to solid diet	Defined as hours from surgery to solid diet tolerance	10 days from surgery	No
Secondary	Naso gastric tube reintroduction	Defined as rate of NGT reintroduction	60 days from surgery	No
Secondary	Days of analgesic usage	Defined as number of days after interventions	60 days from surgery	No
Secondary	Length of hospital stay	Defined as day from surgery to dismission plus eventual days of recovery after readmission	60 days from surgery	No
Secondary	Readmission	Rate of readmission after home dimission	60 day from intervention	No