Mucosal Flap Reinforced Colorectal Anastomosis and Trans-Anal Vacuum Drainage: A Feasibility Study (Endodrain)

Low Anterior Resection Combined With Transanal Reinforcement and Endoluminal Sponge Vacuum Drainage

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: colorectal anastomosis reinforcement and trans-anal drainage

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Martin, Slovakia
    • University Hospital Martin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with diagnosed extraperitoneal rectal cancer, cT1-cT4
• Patient with low anterior resection and double-stapled anastomosis technique

Exclusion Criteria:

• Patients not provided written informed consent
• Patients with cT4: with pelvic side wall involement, requiring pelvic more extensive procedure
• Patients with recurrent rectal cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reinforcement; Low anterior resection + mucosa flap reinforcement + vacuum sponge endoluminal drainage	Procedure: colorectal anastomosis reinforcement and trans-anal drainage; Circular mucosal flap created to cover stapled anastomosis + vacuum sponge drainage; Other Names: Mucosal flap double-stapled anastomosis reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anastomotic leak	Leak of colorectal anastomosis proven by endoscopy/or/and computed tomography	30 days
Defunction ileostomy rate	Rate of fecal diversion in group of treated patients	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morbidity	Complications in postoperative period	30 days

Collaborators and Investigators

• Sponsor: Comenius University
• Collaborators: University Hospital, Martin
• Investigators: Principal Investigator: Alexander Ferko, Prof.MD,PhD, Comenius University, Jessenius Medical Faculty in Martin

Publications and helpful links

General Publications

• Ferko A, Vana J, Adamik M, Svec A, Zacek M, Demeter M, Grendar M. Mucosa plication reinforced colorectal anastomosis and trans-anal vacuum drainage: a pilot study with preliminary results. Updates Surg. 2021 Dec;73(6):2145-2154. doi: 10.1007/s13304-021-01105-4. Epub 2021 Jun 5.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 30, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: low anterior resection; anastomotic dehiscence
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: No 2018/16-UKMT-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No