A new surgical device for the creation of compression anastomoses, the ColonRing*, which is nickel- titanium based, has been introduced. Safety and efficacy of the device have been established in previous clinical studies and the device has been…
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the rate of leaks.
Anastomotic leakage will be defined as clinical symptoms such as fever or
sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis
within 30 days postoperatively leading to a clinical and * or radiological
interventional procedure of the subject, or operation that confirms the leakage
which has been determined to be related to the device.
Secondary outcome
Rate of other device related complications and other parameters during
hospitalization and post procedure.
The post operative parameters that will be measured during hospitalization
period:
1. Hospitalization time (two dates will be recorded: ready for discharge and
discharge). The later noting where the subject was discharged to - e.g. nursing
home or home
2. First day to first postoperative flatus
3. First day to first postoperative bowel movements
4. First day of first postoperative toleration of liquids and solids (time to
*keeping them down*)
Other device related complications during and post procedure - the following
complications will be examined for relation to the device.
5. Intraoperative device failure (including cases of conversion to stapled or
sutured anastomosis that are device related)
6. Bleeding
7. Stricture (either clinical evidence of a stricture or the inability to pass
a 12 mm sigmoidoscope through the anastomosis in a procedure that does not
include a diversion). Note - strictures are unlikely to occur within the study
period
8. Septic complication (including wound infection, pelvic infection,
peritonitis, abscess)
9. Readmission, re-operation, death within 30 days of the procedure. Note - a
death will be considered related by physician discretion if it occurs as a
result of peritonitis, colon obstruction or leak at the anastomosis site.
10. Extra colonic complications (including urinary infection, urinary
retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other
organs - e.g. spleen, ureter)
Length of time and ease of surgical procedure:
The length of time and ease of the surgical procedure will be assessed by the
performing surgeon. The length of time of the procedure will be defined as the
time taken for creation of an anastomosis from the time of completion of two
bowel ends to the beginning of the leak test.
The ease of the surgical procedure as well as the extraction of the device will
be rated on a scale of 1 to 5 with 1 being very difficult, 2 difficult, 3
fairly easy, 4 easy and 5 being very easy.
Ring expulsion time and awareness. The time of expulsion of the ColonRing* and
the ability of the subject to notice this event will be recorded for every
subject.
Background summary
The most common complications of colorectal anastomoses are strictures and
leaks. The leak rate has remained significant over the past years. In lower
rectal procedures, the incidence of leak is substantially higher than after
procedures in the colon. Some leaks will require surgical intervention and can
lead to significant short term and long term morbidity with impaired quality of
life and bowel function. Leakage will also increase the postoperative
mortality. It was shown that when a leak is present, the associated risk of
postoperative mortality is increased to a range of 6% to 39%. As a result of
the complications following colorectal procedures with the current technology
of stapling or suture techniques, the idea of tissue compression has been
revisited.
Currently, colorectal anastomoses are created either with staplers or by a
hand-sewn technique. Both staplers and sutures evoke an inflammatory response
due to a foreign body reaction at the site of the anastomosis, which may
provide a track for bacteria to infect the site. Both have other limitations:
staplers have been reported to have a propensity to stricture formation and it
has been noted that tumor cells are adherent to suture material. However, the
speed of the stapler's procedure and the ability to anastomose at a lower level
than that with sutures, make staplers the most commonly used practice for
colorectal procedures today.
The current mechanical (i.e., stapling pins) or traditional suturing techniques
do not provide a completely *sealed* reconnection due to the gaps between
sutures or staples, until the body*s healing process *plugs* the
microperforation defects. Although considerable progress has been made in the
field of surgical equipment and peri-operative management; complications
related to creation of an anastomosis in colorectal procedures using these
techniques remain major problems. These complications may be associated with
the operator, the surgical technique, the subjects overall condition and
comorbidities, but often occur with no obvious or known risk factor. Typical
complications include leakage, stricture, bleeding, septic complications, extra
colonic complications and others. While some complications are clinically
silent, others require surgical or medical interventions and can lead to
significant morbidity, prolonged hospitalization and increased cost, and even
mortality.
Study objective
A new surgical device for the creation of compression anastomoses, the
ColonRing*, which is nickel- titanium based, has been introduced. Safety and
efficacy of the device have been established in previous clinical studies and
the device has been cleared by the US Food & Drug Administration (FDA) and has
obtained CE mark. The ColonRing* has been marketed since 2008 and over 3000
procedures have been performed to date worldwide.
Preliminary reports from early studies show that this device may address the
limitations that led to the failure of the earlier products for compression
anastomosis. Pre clinical studies using the ColonRing* suggest superiority of
the device over staplers. The clinical results from various studies with the
device suggest that the device is comparable to the current anastomosis
stapling technique. It may have the potential to reduce leak rate and other
complications during and post procedure, specifically parameters related to the
hospitalization period.
The proposed study is a post marketing study intended to gather and record
additional data to further evaluate the performance of the ColonRing* device in
regards to the creation of a colorectal anastomosis.
Study design
prospective, multicenter, open label, non-randomized post marketing study
Intervention
In subjects who meet the inclusion/exclusion criteria the anastomosis will be
created using the ColonRing.
Study burden and risks
Participation in this study will involve mostly standard of care procedures
(considered by most doctors as the currently-accepted method of treatment for a
disease or condition). However, risks associated with the surgical procedure
involving the ColonRing* are described as follows:
• Likely Risks: Risks are similar to those related to all surgery and
anesthesia. Risks relating to surgery and anesthesia will be the same whether
using the standard method or the ColonRing*.
• Less Likely Risks: Bleeding, narrowing, or blockage at the reconnection site
could occur. The ring forms a water tight seal; however, if a leak were to
occur, it would likely occur in the area around the ring. A leak in this area
could cause an infection, an abscess (abdominal infection), or a fistula
(abnormal tube or opening between different parts of intestine or between the
intestine and other tissue). These could require antibiotic therapy, another
operation for repair, the construction of an ostomy (opening of the intestine
through the skin into a bag to divert the stool while the bowel heals), or for
the placement of a drain into the infected area. The occurrence of such a leak
increases other complications and has been shown to increase the risk of death
after surgery. Similar leaks may also occur when using the standard stapler or
suture for reconnection.
• Rare Risks: An unknown allergy to nickel could occur (part of the device*s
ring is nickel).
In the unexpected event that the device does not pass out the body, it may be
necessary to attempt removal using a finger, a proctoscope or another
operation.
• Unforeseen Risks: The treatment with the ColonRing* may involve some
additional risks, the nature of which are unknown. Although the ColonRing*
device is FDA approved, CE certified for this use, and was used in over 3000
clinical procedures, there may be side effects that have not yet been
reported.
Yad Harutzim St., Building 9E, Park Seeim, P.O. Box 8634
42506 Netanya
IL
Yad Harutzim St., Building 9E, Park Seeim, P.O. Box 8634
42506 Netanya
IL
Listed location countries
Age
Inclusion criteria
1. Subject is >= 18 years old.
2. BMI < 34.
3. Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing*.
4. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Exclusion criteria
1. Subject has a known allergy to nickel.
2. Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis.
3. Subject has participated in another clinical study which may affect this study*s outcomes within the last 30 days.
4. Subject's ASA (American Society of Anesthesiology) score 4 or 5.
5. Subject has a concurrent or previous invasive pelvic malignancy.
6. Subject has a systemic or incapacitating disease.
7. Subject has extensive local disease in the pelvis.
8. Subject requires more than one anastomosis during the surgery.
9. Women who are known to be pregnant.
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 |
|---|---|
| CCMO | NL31790.060.10 |