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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 21, 2018

Detailed 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.

Interventions

  • 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.
  • Procedure: 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.
  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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 Rel Stapler

Clinical Trial Outcome Measures

Primary Measures

  • Length of stay
    • Time Frame: 1 month
    • is identified when the patient has tolerated diet and has had bowel movements and is discharged from the hospital

Secondary Measures

  • Return to normal peristalsis
    • Time Frame: 1 week
    • Physiological parameter
  • Size of the surgical wound
    • Time Frame: 1 month
    • we measure the wound in cm
  • Rate of Surgical Site Infection
    • Time Frame: 1 month
    • clinical wound infection or positive culture
  • Rate of Incisional Hernia
    • Time Frame: 1 year after discharge
    • Physical exploration and CT scan (performed during the follow up)
  • Aesthetic result
    • Time Frame: 1 month after discharge
    • Questionnaire
  • Postoperative pain
    • Time Frame: 1 month after discharge
    • Questionnaire

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundació Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jesus Bollo, Principal Investigator, Fundació Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau

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