Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04735107 |
| Other study ID # |
No 2018/16-UKMT-12 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
September 1, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Comenius University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Dehiscence of colorectal anastomosis is a serious complication associated with
increased mortality and impaired functional and oncological outcomes. We hypothesised that
anastomosis reinforcement and vacuum trans-anal drainage could eliminate some risk factors of
colorectal anastomotic dehiscence,including mechanically stapled anastomosis instability and
local infection.
Description:
The study included consecutive patients older than 18 years who had low anterior resection of
the rectum and anastomosis performed by double-stapler technique, for rectal cancer located
within 10 cm from the anal verge. All patients had undergone pelvic magnetic resonance
imaging. Nutrition screening was performed in all patients. If patients had undergone
neoadjuvant chemoradiotherapy (CHRT), restaging was performed within 6 weeks of CHRT
completion, and surgery was performed 10 weeks after CHRT completion. For the surgical
procedure, low anterior resection (LAR) was performed by experienced surgeons who perform
more than 50 rectal procedures per year and have sufficient expertise in minimally invasive
surgery. Oral bowel preparation was used preoperatively and antibiotics were administered
according to protocol.
1. Surgical technique
The procedure milestones (descending colon blood perfusion, tension-free anastomosis,
safely performed stapled anastomosis and reinforcement, and safely performed mucosal
flap) were defined. Simultaneous checkpoints to control milestones were identified and
methodology of their documentation (video, photography) were defined. The purpose was to
achieve demonstrable control over the individual steps during the surgical procedure.
1.1 Abdominal phase
Laparoscopic procedures were performed in the Lloyd-Davis position, using the 4-ports
technique. During the abdominal phase, dissection was guided by a medio-lateral
approach. A high tie of the a. mesenterica inferior (AMI) was performed in all patients.
Dissection was performed medio-laterally and down to the pelvic floor according to the
principles of total mesorectal excision (TME). The rectum was transected using an
endostapler after lavage with Betadine solution (Egis Pharmaceuticals, PLS, Budapest,
Hungary). Furthermore, the splenic flexure was fully mobilized using a combination of
medio-lateral and lateral approaches. In most cases, the inferior mesenteric vein was
divided.
The marginal artery was dissected and the character of arterial blood flow was carefully
evaluated; pulsatile arterial blood flow was considered as sign of adequate colon
perfusion (Checkpoint 1).
A specimen of tumor was pulled through the minilaparotomy and resected. The descending
colon was divided at the level of the distal part and the colonic mucosa was again
evaluated with respect to blood perfusion; a light red or pink colored mucosa and fresh
light red capillary bleeding were considered as signs of good colonic mucosa perfusion
(Checkpoint 2). The colon needed to lie freely in the sacrum excavation and no tension
was allowed on the mesenterial site. This was confirmed by lifting the colon ventrally
from the sacrum at the promontory level after anastomosis construction (Checkpoint 3).
The anastomosis was performed end-to-end using a double-stapler technique, strictly
between the descending colon and rectum in a tension-free manner. A pelvic drain was
left in place till the third postoperative day.
1.2 Trans-anal phase
As part of the trans-anal phase, a Lone Star retractor (Cooper Surgical, Inc. USA) and a
plastic single use anoscope were applied. An initial, careful inspection and manual
check of the stapler anastomosis integrity, the blood supply to the colonic mucosa, and
signs of a tension-free anastomosis were performed (Checkpoint 4). The mucosal flap was
subsequently created using individual polydiaxone (PDS) II 5/0 sutures (polydiaxonone,
Ethicon, Johnson&Johnson, USA): individual stitches were placed on each quadrant; and
then another four stitches were applied in between. It is important to note that the
condition of the mucosal flap upon creation were signs of a floppy, prolapsing colonic
wall into the anastomosis. Finally, a sponge soaked (Endo-SPONGE, B. Braun, Germany)
with povidone-iodine (Betadine, Egis Pharmaceuticals, Budapest, Hungary) was introduced
into the anastomosis. The trans-anal sponge drain was removed 24 hrs postoperatively.
1.3 Fecal diversion
The decision on diversion was based on intraoperative checkpoint adherence: when
Checkpoint 6 and 7 were not fulfilled, an ileostomy was created.
2. Follow up
The data regarding the type of procedure, type of anastomosis, stapler diameter, the number
of stapler cartridges used, dissection of the mesenteric blood vessels, and complete
histopathology were collected prospectively. C-reactive protein (CRP) levels were assessed on
the third and fifth day after surgery.0 Patients were followed up for 3 months, and
postoperative endoscopy was performed before discharge, usually on postoperative day 7, 1
month after surgery, and 3 months after surgery.
