New Trials Forum

One of the many insightful sessions that took place on day two of our 17th annual congress #ESCP2022 was a Research Symposium on New Trials.

This session saw six leading researchers present cutting-edge trials. These trials were in the early stages, meaning that they had either only just begun or had just secured preliminary results so far.

First to speak was Dominik Jauch (Germany) who introduced his presentation on Abril-Trial Intraoperative Antegrade Bowel Lavage for Ileostomyreversal Vs. Standard-Ileostomy-Reversal – A Prospective Randomized Multicenter Trial. The aim of this trial is to compare the standard ileostomy reversal (S-IR) with ileostomy reversal with intraoperative antegrade bowel lavage (ABL-IR), flushing the aboral small intestinal lumen with a foley-catheter and 100 ml NaCl 0.9% or ringer-lactate-solution.

New trials 1

The trial is being conducted in south-west Germany and plans to run a recruitment period of 18 months.

Feedback from the audience was extremely positive as listeners commented on the pragmatic style of the trial, which they expect will attract a high rate of patient consent and will allow for international replication.

We then heard from Roberto Peltrini (Italy), who kicked off Benchmarks in Low Anterior Resection For Rectal Cancer To Prevent Anastomotic Leakage: A Cluster Randomized Trial. Since anastomotic leakage is still a common complication after anterior resection (ranging from 3% to 23%), Roberto explained that this study will evaluate the impact of a comprehensive multi-intervention protocol to prevent anastomotic leakage (AL) after rectal cancer surgery.

New trials 2

During the session’s Q&A, Roberto received praise for how this links to similar studies, and recieved advice on measuring the uptake of interventions to ensure that the trial is more effective.

Following Roberto, we heard from Jim Khan (Australia) who delivered RoLaCaRT: An International Randomised Phase II Trial Comparing Robotic-Assisted Right Hemicolectomy Versus Laparoscopic-Assisted Hemicolectomy for Resection of Adenocarcinoma of the Caecum, Ascending or Proximal Transverse Colon.

He emphasised the that this trial had potential to improve the survival rate of colon cancer – which has not seen an improvement in five years. To achieve this, the trial aims to compare the use of robotic surgery with laparoscopic surgery for the treatment of right-sided colon cancer.

Participants will be randomly allocated to receive either robotic or laparoscopic surgery for the surgical treatment of their cancer. There will be a two in one chance that patients are allocated to receive robotic surgery. This study will evaluate the short- and longer-term outcomes including quality of life, cost-effectiveness of each surgery and surgeons’ experience with the robotic surgery approach.

Jim spoke of eight parameters that have been identified for success in this trial, outlined in the image below:

New trials 3

Next on stage was Ugne Imbrasaite (Lithuania) for her talk on Bowel Rest with Total Parenteral Nutrition as an Alternative to Diverting Loop Ileostomy in High-Risk Colorectal Anastomosis: Randomised Controlled Non-Inferiority Trial.

New trials 4

Ugne explained how preventing ileostomy usually helps high-risk colorectal anastomosis, but this can affect general nutritional status, decreases quality of life and requires additional operation for closure, with roughly 20% of these ileostomies never closing.

Total parenteral nutrition (TPN) is used in upper gastrointestinal tract surgery, patients with high-output proximal small bowel fistula, severe sepsis or ileus. Several old studies mention this method as an alternative to protective colostomy. This study hypothesises that bowel rest with TPN could replace diverting loop ileostomy in high-risk colorectal anastomosis and might protect anastomosis by defunctioning the distal bowel.

One of the aims of the trial is to talk to the patient and find out what they feel will aid their quality of life for the future – something that received positive feedback from the audience.

We then heard from Quentin Denost (France) who gave an overview on A Phase III Randomized Trial Evaluating the Tailored Versus The Systematic Use of Defunctioning Stoma After Total Mesorectal Excision For Rectal Cancer (Greccar 17).

This interesting presentation covered how the systematic use of a defunctioning stoma, over 3 months, to protect low colorectal anastomosis (below than 7 cm from the anal verge) is standard practice. However, controversy exists around the role of defunctioning stomas, mainly due to stoma-related complications. Quentin highlighter reports that patients either without defunctioning stoma, or with early stoma closure (days 8–12 after TME) have a better functional outcome than patients with systematic defunctioning stoma for 3 months.

New trials 5

The main objective of this trial is to compare the impact of a tailored use of defunctioning stoma after TME versus the systematic use of defunctioning stoma on quality of life at 12 months after surgery. This is primarily a French trial, however, Quentin hopes for it to grow internationally.

Sara Kuiper (Netherlands) was next on stage to present Effectiveness and Cost-Effectiveness Of Rubber Band Ligation Versus Sutured Mucopexy Versus Haemorrhoidectomy In Patients With Recurrent Haemorrhoidal Disease (HD) (Napoleon Trial): From A Randomized Controlled Trial To A Comprehensive Cohort Study.

The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy, versus haemorrhoidectomy in patients with recurrent HD.

After a disappointing participation rate in the study so far, after patients responded negatively to a computer deciding their surgery, the trial has found that a comprehensive cohort is the most effective design for encouraging eligible patients to participate.

New trials 6

Following Sara, Aya Riad (UK) took to the stage to share the EuroSurg Cassade Case Study Results. The primary aim of this study is to audit compliance to pre -, intra -, and postoperative audit standards in reducing the risk of postoperative cardiac complications (PCCs).

New trials 7

Aya praised how the preliminary results showed that the trial exceeded its target of patient participation. Their statistics on participation show:

  • 30 countries
  • 446 hospitals
  • 4,918 collaborators
  • 24,260 patients

Concluding the talk, Aya shared the results of the CASCADE study:

  • The adjusted PCC rate was 2.38%
  • There is substantial variation in adherence to perioperative preventative measures
  • There is ongoing analysis of the CASCADE dataset to explore associations between interventions & PCC rates

Finally, we heard from Gaetano Gallo (Italy) who shared the results of the ESCP Pilonidal Management Project.

This was a global survey on the treatment of pilonidal disease (PD) among ESCP members across Europe for the purpose of capturing different trends in the treatment of PD. Overall, 48 countries took part, which Gaetano confirmed gave a good representation across the coloproctology society.

New trials 8

His concluding remarks on the survey included how most respondents are not completely satisfied with the management and treatment of PD. Most importantly, the study found that there is a lack of experience and/or skill and interest in dealing with PD amongst most surgeons, highlighting that more education is needed for better treatment.

For the latest updates from #ESCP2022, make sure you’re following @escp_tweets on Twitter.

ESCP Affiliates