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

F

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

Status

Completed

Conditions

Pain

Treatments

Device: Proximate Linear Cutter
Device: Echelon Endopatch
Procedure: Intracorporeal anastomosis.
Procedure: Extracorporeal anastomosis

Study type

Interventional

Funder types

Other

Identifiers

NCT02667860
IIBSP-AIE-2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 2 patient groups

Intracorporeal anastomosis
Experimental group
Description:
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.
Treatment:
Procedure: Intracorporeal anastomosis.
Device: Echelon Endopatch
Extracorporeal anastomosis
Active Comparator group
Description:
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
Treatment:
Procedure: Extracorporeal anastomosis
Device: Proximate Linear Cutter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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