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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02667860
Enrollment
140
Registered
2016-01-29
Start date
2015-05-20
Completion date
2018-07-21
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

intracorporeal anastomosis, laparoscopic colectomy, outcomes, length of stay, analgesia, aesthetic, extracorporeal anastomosis, laparoscopic

Brief 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.

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

PROCEDUREIntracorporeal 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.

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.

DEVICEEchelon Endopatch

Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.

DEVICEProximate 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Length of stay1 monthis identified when the patient has tolerated diet and has had bowel movements and is discharged from the hospital

Secondary

MeasureTime frameDescription
Size of the surgical wound1 monthwe measure the wound in cm
Rate of Surgical Site Infection1 monthclinical wound infection or positive culture
Return to normal peristalsis1 weekPhysiological parameter
Aesthetic result1 month after dischargeQuestionnaire
Postoperative pain1 month after dischargeQuestionnaire
Rate of Incisional Hernia1 year after dischargePhysical exploration and CT scan (performed during the follow up)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026