Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy

Pain Clinical Trial

Official title:

Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667860
• Other study ID #: IIBSP-AIE-2015-01
• Status: Completed
• Phase: N/A
• Start date: May 20, 2015
• Est. completion date: July 21, 2018

Study information

• Verified date: January 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic results, analgesia requirements and length of hospital stay. The objective of this study is to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in patients undergoing laparoscopic right hemicolectomy.

Description:

Laparoscopic surgery has entailed a great technical revolution in colorectal surgery, providing a better and quicker return to normal functions of the patients, associating a lower morbidity and better aesthetic results compared with traditional open surgery. This study wants to find the difference between intracorporeal and extracorporeal anastomosis.

The creation of an intracorporeal anastomosis in right hemicolectomy seems superior to extracorporeal anastomosis in terms of recovery of the normal bowel function, wound size, aesthetic results and analgesia requirements. This will entail a shorter hospital stay. Several studies have demonstrated this but all of them are retrospective non randomised.

In terms of postoperative pain, the most accepted theory is that it depends on the traction of the porto-mesenteric axis. When the intracorporeal anastomosis is performed there is no traction of this mesenteric axis while in the extracorporeal anastomosis this traction is more important in obese patients.

This traction of the mesentery, as well as being one of the main factors related with postoperative pain, is responsible of the postoperative adynamic ileus, that should have a higher incidence when the manipulation is higher.

In the patients undergoing an intracorporeal anastomosis, the assistance incision will be a suprapubic Pfannenstiel. In the patients undergoing an extracorporeal anastomosis the assistance incision will be a transverse in the right upper quadrant. It is well known that the Pfannenstiel incision has a lower incidence of superficial surgical wound infection, a lower rate of incisional hernia, a lower need of analgesics, and better aesthetic results, when compared with the incision in the right upper quadrant.

All this factors should entail a lower hospital stay in patients undergoing an intracorporeal anastomosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Surgical procedure with curative purpose.

• American Society of Anaesthesiologists Physical Status (ASA) I, II and III.

• Elective surgery.

• Informed consent.

Exclusion Criteria:

• Denial of informed consent.

• Advanced neoplasia.

• Urgent surgery.

• ASA IV.

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Intracorporeal anastomosis.
Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.
• Extracorporeal anastomosis
A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler.

Device:
• Echelon Endopatch
Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.
• Proximate Linear Cutter
Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	is identified when the patient has tolerated diet and has had bowel movements and is discharged from the hospital	1 month
Secondary	Return to normal peristalsis	Physiological parameter	1 week
Secondary	Size of the surgical wound	we measure the wound in cm	1 month
Secondary	Rate of Surgical Site Infection	clinical wound infection or positive culture	1 month
Secondary	Rate of Incisional Hernia	Physical exploration and CT scan (performed during the follow up)	1 year after discharge
Secondary	Aesthetic result	Questionnaire	1 month after discharge
Secondary	Postoperative pain	Questionnaire	1 month after discharge