The aim of this research is to investigate the efficacy and mechanism of anew technology, intra-operative fluorescence angiography (IFA), inreducing anastomotic leak rate following elective rectal cancer surgery.The comparator will be standard white…
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
* Clinical anastomotic leak rate within 90 days post-operation
Secondary outcome
Secondary endpoints:
* Anastomotic leak rate within 90 days post-operation
* Changes in planned anastomosis, i) including the decision to
undertake a permanent stoma rather than an anastomosis, ii) the site
of proximal bowel used for anastomosis, iii) the site of rectal remnant
used for anastomosis and iv) the decision to undertake a diverting
stoma.
* Rate of stoma (temporary or permanent)
* Operative and post-operative complications (Clavien-Dindo for
complication-level classification and Comprehensive Complication
Indicator for patient-level classification) within 90 days of operation
* Length of post-operative hospital stay
* Low Anterior Resection Syndrome (LARS) score at 30 days and at 90
days post-operation * participants without defunctioning ileostomy
* Rate of re-interventions within 90 days and within 12 months1
* Quality of life (QLQ-C30, QLQ-CR29, EQ-5D) at 30 days, 90 days and
12 months1 post-operation
* Health resource utilisation at 30 days, 90 days and 12 months1 postoperation.
* Death within 90 days of operation
* Vascular anatomy (mechanistic sub-study)
* Rectal perfusion (mechanistic sub-study)
* Rectal microbiome profile (mechanistic sub-study)
Background summary
Colorectal cancer is the third most common cancer in the UK, with 30% of
cases involving the rectum. Surgery can offer a cure, but comes at a cost
in terms of morbidity and mortality. The most feared complication of rectal
cancer surgery is anastomotic leak, which is reported in 10% to 15% of
patients. Approximately 30,000 * 40,000 colorectal anastomoses are
constructed each year in the NHS, most usually for colorectal cancer.
Anastomotic leak is therefore a significant healthcare burden. It has a
negative impact on patient recovery and consumes NHS resources for
remedial interventions. Patients who survive anastomotic leak suffer longterm
consequences with reduced quality of life, high rates of wound
complications and permanent stoma, and increased risk of cancer
recurrence. Despite advances in surgery, with the introduction of stapling
technology and laparoscopic/robotic techniques, there has been little
progress in reducing the rate of AL and associated morbidity. Recently,
intraoperative fluorescence angiography (IFA) has been introduced to
evaluate anastomotic blood supply, with promising early results
Study objective
The aim of this research is to investigate the efficacy and mechanism of a
new technology, intra-operative fluorescence angiography (IFA), in
reducing anastomotic leak rate following elective rectal cancer surgery.
The comparator will be standard white light endoscopic surgery, using
either a laparoscopic or robotic technique.
Study design
A prospective, unblinded, parallel group, non-CTIMP, multicentre,
European, randomized controlled trial comparing surgery with IFA against
standard care (surgery with no IFA) to determine the effect on anastomotic
leak in patients undergoing elective anterior resection for rectal cancer.
Two sub-studies will explore the mechanisms of anastomotic leak.
Participants will be randomised on a 1:1 basis to receive either surgery
with or without IFA. Randomisation will be performed by the Clinical Trials
Research Unit (CTRU), Leeds, UK
Intervention
Surgery with no IFA: the anterior resection (high or low) will be performed
according to the surgeon*s usual technique, using either a laparoscopic or
robotic approach, with white light assessment of bowel perfusion. The
specifics of each operation will be at the discretion of the operating
surgeon.
Surgery with IFA: the anterior resection (high or low) will be performed
according to the surgeon*s usual technique, using either a laparoscopic or
robotic approach. ICG will be administered intravenously at two points
during the operation for perfusion assessment using near-infrared
laparoscopy. The specifics of each operation, including the decision to
make a change to the planned anastomosis following IFA assessment, will
be at the discretion of the operating surgeon.
Study burden and risks
Surgery with no IFA: the anterior resection (high or low) will be performed
according to the surgeon*s usual technique, using either a laparoscopic or
robotic approach, with white light assessment of bowel perfusion. The
specifics of each operation will be at the discretion of the operating
surgeon.
Surgery with IFA: the anterior resection (high or low) will be performed
according to the surgeon*s usual technique, using either a laparoscopic or
robotic approach. ICG will be administered intravenously at two points
during the operation for perfusion assessment using near-infrared
laparoscopy. The specifics of each operation, including the decision to
make a change to the planned anastomosis following IFA assessment, will
be at the discretion of the operating surgeon.
Participants will be assessed at 30 days and 90 days post-operation, with
a rectal contrast enema taking place between 4-6 weeks post-operation.
Quality of Life (QoL) and participant reported outcomes (assessed using
the EQ-5D-5L, EORTC-QLQC30, EORTC-QLQCR29 and Low Anterior
Resection Score (LARS) questionnaires) and resource use (UK sites only)
will be measured at 30 days and 90 days post randomisation.
Complications will be documented during trial treatment and follow-up.
Beckett street 1
Leeds LS9 7TF
GB
Beckett street 1
Leeds LS9 7TF
GB
Listed location countries
Age
Inclusion criteria
aged * 18 years with a diagnosis of rectal cancer,
suitable for curative resection by high or low anterior resection
(laparoscopic or robotic) with anastomosis.
Exclusion criteria
1. Patients not undergoing colo-rectal/anal anastomosis e.g. abdominoperineal
excision of
rectum (APER), Hartmann*s procedure.
2. Patients undergoing synchronous colonic resections.
3. Locally advanced rectal cancer requiring extended or multi-visceral excision.
4. Recurrent rectal cancer
5. Coexistent colorectal pathology e.g. synchronous cancers, inflammatory bowel
disease.
6. Previous pelvic radiotherapy for pathology unrelated to diagnosis with
rectal cancer e.g.
treatment for prostate cancer
7. Hepatic dysfunction, defined as bilirubin outside of institutional limits
and/or ALT/AST >2.5
x institutional upper limit of normal.
8. Renal dysfunction, defined as eGFR <40 mL/min/1.73m2 (or a serum creatinine
value4
>10% of upper value for normal institutional limits if eGFR is not performed
locally)
9. Known allergy to ICG, iodine, iodine dyes, or drugs known to interact with
ICG e.g.
anticonvulsants, bisulphite containing drugs, methadone, nitrofuratoin.
10. Pregnant or likely to become pregnant within 3 months of surgery5
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ISRCTN | ISRCTN13334746 |
CCMO | NL63808.018.18 |