Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05000580 |
| Other study ID # |
CALM-V3 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
July 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Surgical Trainees East of England Research Collaborative |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Colorectal anastomotic leaks (AL) are associated with high morbidity and mortality.
Management of AL and its intra-operative decision making is often difficult. The aim of this
multi-centre study is to explore different management strategies, including different
surgical options, and analyse rates and patterns of failure of initial management.
All consecutive patients who had a confirmed AL after elective colorectal resections from 1st
January 2014 to 31st December 2019 were included at seven hospitals across the East of
England Region. Morbidity (length of stay, and failures) and mortality were compared across
the different management strategies, and survival analyses were performed.
Description:
The International Study Group of Rectal Cancer proposed a grading system for the management
of colorectal anastomotic leaks (Rahbari et al., 2010). Grade A anastomotic leaks are
identified by radiographic findings of a perianastomotic fluid collection, leakage of
contrast through the anastomosis, or observation of new drainage of enteric contents through
either a drain or through a fistula but without accompanying clinical complaints. These may
be managed expectantly. These may become apparent during the preoperative work-up prior to
closure of a diverting ostomy and will at least delay reversal. Grade B leakage requires
therapeutic intervention but does not necessarily require reoperation. Antibiotics and
percutaneous drainage of fluid collections are the most common nonoperative interventions.
Grade C anastomotic leakage requires relaparotomy. Surgical treatment is performed with the
goal of controlling life-threatening sepsis. The traditional operation with takedown of the
anastomosis and end colostomy may be appropriate, but washout with drain placement and
diverting loop ileostomy may also be appropriate. 1 Elective colorectal resection surgeries
have an over 30-day mortality rate of 5.8%. While emergency resections have a 7.8% mortality
(Morris, 2011). Experiencing an anastomotic leaks should not have a higher mortality than the
above rates.
Aim The main interest of this study is to firstly assess our practice and management of AL,
evaluate whether hospitals in the region are identifying AL as per The International Study
Group of Rectal Cancer, grading the AL as Grade A, B, and C above, and analyse the natural
evolution of leaks and their subsequent treatment(s).
Outcomes of Interest
Management of anastomotic leaks and associated outcome in terms of:
Primary objectives:
1. 2-year mortality after anastomotic leaks of different grades.
Standards of reference for audit:
Elective colorectal resection surgeries have an over 30-day mortality rate of 5.8%.
While emergency resections have a 7.8% mortality (Morris, 2011). Experiencing an
anastomotic leaks should not have a higher mortality than the above rates.
2. Outcomes of different treatment strategies of Colorectal anastomotic leaks.
3. Grading of AL as described above.
Secondary Objectives include:
- Need for subsequent management strategies after failure of initial strategy.
- Proportion requiring laparotomy, bowel resection, defunctioning.
- Length of ITU stay, overall length of hospital stay
- Non-surgical complications (pneumonia, urine infection, DVT, PE, MI etc)
- Delay / change in oncological management Methods Data will be collected retrospectively
going back to 2014 (five years), at multiple East of England sites. The study will
initially commence across trusts in the East of England Deanery however efforts will be
made to recruit other research collaboratives through existing and established ties with
the National Research Collaborative.
Population Identification
Patients can be identified and recruited to the study through a variety of ways:
- Multi-Disciplinary Teams (MDTs): Most MDTs will record data as to who has had a leak and
what treatment they have had or are to have
- Colorectal Clinical Nurse Specialists (CNS): In most trusts, the CNS keep records of
patients who have had complications
- National Bowel Cancer Audit (NBOCAP): Although this will not capture patients who have
had benign disease, it will provide data on patients with cancer
- Consultants: Many consultants collect their own data, and this can be an excellent
source of information An estimated of 10-30 leaks occur every year at each site. We
expect to have between 30-60 leaks with 3 year follow up per hospital site.
Study duration Data collection 3-6 months from date of project launch (October 2019).
Reminders for date of study closure will be sent closer to the time.
Variables
It must be stated that the aim of this study is not to investigate 'leak-rates' or
comparatively analyse data of individual surgeons or trusts. No patient identifiable or
surgeon identifiable information will be requested. Data and outcomes from individual trusts
will not be compared against each other. The name of the trust will be recorded as one of the
variables only for data validation purposes and to identify the lead investigators at each
trust for the purposes of communication only. Names of Trusts or Surgeon level details will
not be published. The variables that will be recorded are as follows:
- Trust
- Local Patient ID
- Gender (M/F)
- Age At Time (of Surgery) (Whole number)
- Indication for surgery (where is cancer, IBD?)
- Comorbidity 1 (in any order)
- Comorbidity 2 (in any order)
- Comorbidity 3 (in any order)
- Comorbidity 4 (in any order)
- Date of Index Surgery
- Type of Index Surgery (right, left, segmental sigmoid colectomy, AR)
- Elective / emergency
- Date Leak Detected
- Leak size (description on CT (size, localized, small, free)
- Symptomatic/Non-Symptomatic Leak
- Treatment 1 (IV antibiotics are always given once a leak is diagnosed. So it should not
be inserted automatically as treatment 1. So I would reserve inserting "IV antibiotics"
or "conservative" as treatment 1 unless the patients actually had a trial of
conservative management.)
- date treatment 1 (chronological order)
- Treatment 2
- date treatment 2 (chronological order)
- Treatment 3
- Date treatment 3 (chronological order)
- Type of Rescue Surgery Performed (?laparotomy, bowel resection, defunctioning)
- Length of Stay in ITU Post Leak (in days)
- Length of stay in Leak episode (total in days, if the leak occurred during the index
operation episode, it is the total length of stay in that whole episode.)
- Date CT confirmed leak resolved
- Number of days of drainage (if drain inserted. This column is for radiologically
inserted drains; or EUA inserted drains in low pelvic leaks. It is the total number of
days a drain was kept in until removal of the drain (including changes).)
- Date of Death
- Date last seen alive (censored)
- Other Comments
Inclusion:
- Age ≥18 years old
- Patients undergoing colorectal anastomosis for any pathology (benign or malignant),
during an elective or emergency admission, who had an AL.
- Laparoscopic or open surgery Ethical approval & Registrations This is a retrospective
audit, aiming to analyse the region trust's management of colorectal anastomotic leaks,
and whether this is in accordance with published literature. This study therefore needs
to be registered as a retrospective audit in each trust. Please keep a record of those
that were subsequently excluded and the reason why (most probably was not a leak, or not
managed as leak).
