Clinical trial NCT02667860: Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy
Official title: Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: intracorporeal anastomosis
laparoscopic colectomy
outcomes
length of stay
analgesia
aesthetic
extracorporeal anastomosis
laparoscopic
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of stay
timeFrame: 1 month
Secondary outcomes:
measure: Return to normal peristalsis
timeFrame: 1 week
measure: Size of the surgical wound
timeFrame: 1 month
measure: Rate of Surgical Site Infection
timeFrame: 1 month
measure: Rate of Incisional Hernia
timeFrame: 1 year after discharge
measure: Aesthetic result
timeFrame: 1 month after discharge
measure: Postoperative pain
timeFrame: 1 month after discharge
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Jesus Bollo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bollo J, Turrado V, Rabal A, Carrillo E, Gich I, Martinez MC, Hernandez P, Targarona E. Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial). Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17.
citation: Bollo J, Salas P, Martinez MC, Hernandez P, Rabal A, Carrillo E, Targarona E. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy assisted by laparoscopy: study protocol for a randomized controlled trial. Int J Colorectal Dis. 2018 Nov;33(11):1635-1641. doi: 10.1007/s00384-018-3157-9. Epub 2018 Sep 6.