Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBordeaux Colorectal Institute
About this trial
The objectiive of this prospective, international cohort is to compare two anastomotic techniques (DS vs TTSS) by collecting data during the surgery, and postoperatively (morbidity and functional outcomes).
The choice of technique is left to the discretion of the surgeon based on her/his practices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18
Patients with rectal cancer lower than 12 cm from the anal verge requiring either a stapling anastomosis below 7 cm from the anal verge,
Patients with powered mechanical anastomosis (INTOCARE devices)
Patients with no metastasis
Disqualifiers
Patients with handsewn anastomosis
Patients with perforated rectal cancer or preoperative pelvic sepsis ;
Patients with inflammatory bowel disease;
Patients operated on in emergency ;
Trial population
In this exploratory, observational, prospective, IDEAL stage 2b International cohort study, we aim to include 400 patients with resection rectal and low powered colorectal anastomosis. This study is to compare two anastomotic techniques (DS vs TTSS) by collecting data during the surgery, and postoperatively (morbidity and functional outcomes). Surgeons at each center perform one or both techniques. When both types of stapling are possible, the choice of technique is made by the surgeon during the preoperative consultation, in the best interest of the patients, after a case-by-case assessment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques
Trial outcomes
Primary outcomes
1
To assess and compare the rate of anastomotic leakage at 1 month after rectal excision between double and single-stapling low colorectal anastomosis using advanced powered stapler
Proportion of anastomotic leakage (clinical and radiological) at 1 month after rectal surgery between double- and single-stapling low colorectal anastomosis using advanced powered stapler.
Time frame
From the surgery to one monthSecondary outcomes
1
Overall morbidity and mortality rates at 1 month
Postoperative morbidity and mortality according Clavien-Dindo classification at 1 month
Time frame
At 1 month after the end of the surgery2
The rate of anastomotic leakage at 6 and 12 months after rectal surgery;
Rate of defunctioning stoma at 1, 6 and 12 months after surgery;
Time frame
At 12 month after the end of the surgery3
Quality of life with QLQ C30 questionnaire
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. This is a patients self-rating questionnaire that measures five functional scales (physical, role, social, emotional, and cognitive) three symptom scales (fatigue, pain, nausea and vomiting) A global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. Scores can be linearly transformed to provide a score from 0 to 100 REF. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales. 9 dimensions will be assessed with: PF : Physical Functioning RF : Role Functioning CF : Cognitive Functioning EF : Emotional Functioning SF: Social Functioning FA : Fatigue PA : Pain NV : Nausea and Vomiting QL : Global health status
Time frame
At 1, 6 and 12 months after rectal surgery4
Quality of life with QLQ CR29 questionnaire
The QLQ-CR29 (Quality of life of rectal cancer patients with 29 questions) has five functional and 18 symptom scales. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.
Time frame
At 1,6 and 12 months after rectal surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: