The primary objective of this second phase study is to estimate the occurrence of anastomotic leakage when the C-seal is used.Secondary objectives are:* Feasibility of applying the C-seal, especially considering the improved attachement to the…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is recovery of the patient without clinical manifestation
of anastomotic leakage. Anastomotic leakage is considered to be clinical
manifest if any of the following occurs:
* Relaparotomy with dismantling of the anastomosis and creation of an end
colostomy
* Relaparotomy with placement of drains in the pelvis
* Relaparotomy with creation of a diverting ostomy
* Radiologically guided drainage of any fluid in the pelvis
Secondary outcome
- The assessment of technical feasibility defined as technical succes,
determined by a gastrografin enema X-ray of the rectum (through the C-seal
drain) one week after the operation
- The successful clearance of the C-seal at 6 weeks without the occurrence of a
serious adverse event.
- Technical success: The Technical success is defined as the peroperatively
successful application of the C-seal.
- Acute procedural success: Acute procedural success is defined as the
successful application of the C-seal without the occurrence of a Serious
Adverse Effects (SAE) caused by the drain/protector during or directly after
the procedure.
- Procedural success: The successful placement of the C-seal and the successful
clearance at 6 weeks with absence of any serious adverse events up to 30 days.
- Concentrations of MMP's, TIMP's, pro-inflammatory en pro-coagulatory factors
in blood and tissue samples will be measured. We will determine the relation
between their concentrations and the occurence of anastomotic leakage.
Background summary
Anastomotic leakge remains an serious and frequent complication after low
anterior resection. The incidence of anatomotic leakage is reported variably in
the literature, but is likely to be between 10 and 15 percent, depending on the
indication.
Anastomotic leakage is associated with mortality and morbidity. Patient usually
experience an episode of peritonitis and sepsis. Usually they end up with a
definitive stoma.
The C-seal is a biodegradable drain that is stapled to the anastomosis during
the operation. The drain is pulled through the anus by the circular stapler. In
this way the anastomosis is sealed from the inside. Any small defects in the
anastomosis will not cause leakage and are allowed to heal secundary.
In a previous phase our group performed a pilot study to the application of the
C-seal. Apart from some technical difficulties related to gluing the C-seal to
the cap of the stapler, this pilot study was successful. No anastomotic leakage
occured in the 15 included patients.
Study objective
The primary objective of this second phase study is to estimate the occurrence
of anastomotic leakage when the C-seal is used.
Secondary objectives are:
* Feasibility of applying the C-seal, especially considering the improved
attachement to the circular stapler using adhesive tape
* Estimation of patient friendliness of the drain, at 14 days and 6 weeks.
* Inventarisation of complications.
* Identification of risk factors predicting the occurence of anastomotic
leakage by analysing blood and tissue samples.
Study design
Multicenter study, coordinated by the UMCG. Phase II study.
Intervention
Resection of the rectum or sigmoid colon. Anastomosis by use of a circular
stapler. The anvil of the stapler is placed inside the C-seal. In this wat the
C-seal is stapled to the anastomosis.
If a patient is also willing to donate blood- and tissue samples for additional
secondary research, 3 extra blood samples will be drawn and a small sample of
the resected tissue will be used for this research.
Study burden and risks
After the operation the C-seal is pulled through the anus. Stool can pass
through the C-seal and may lead to some hygienic concerns.
After 1 week a gastrografin enema X-ray study is proposed. This study is
performed outside the regular routine of postoperative care.
It is conceivable that for some reason the C-seal gets clogged. This may lead
to anastomotic leakage, peritonitis, sepsis and death. We estimate this risk as
very small.
No additional interventions are necessary for the collection of blood and
tissue samples. Blood will be drawn at a moment it is drawn anyway for
preparation of the surgical intervention and during the surgical intervention,
blood will be drawn via a peripheral venous.
Postbus 30.001
9700 RB Groningen
Nederland
Postbus 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Age > 18 years;
The patient requires an anastomosis, maximally 15 cm proximal from the anus
The patient will receive a colorectal anastomosis by means of stapling;
The patient is willing and able to comply with the specified follow-up evaluation;
The patient must provide written informed consent prior to the procedure.
Exclusion criteria
Patient treatment is acute (not elective);
Patient is associated with infections at the time of intervention (peritonitis);
Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study;
Patients with ASA classification >3;
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 | NL27454.042.09 |