Clinical trial · Observational
Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)
Low Powered Colorectal Anastomosis After Rectal Excision : An Exploratory, Observational, Prospective, IDEAL Stage 2b International Cohort Study (OASIS)
NCT07146334CI-TRIAL-00094227OASISnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery Indication | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques
- description
- This is an international cohort (France and other international centers) which consists of including patients undergoing rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques. 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.
Primary outcomes (1)
- measure
- 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
- timeFrame
- From the surgery to one month
- description
- 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.
Secondary outcomes (11)
- measure
- Overall morbidity and mortality rates at 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Patients operated on by mini-invasive rectal excision (laparoscopic, robotic or TaTME); * Patients with or without defunctioning ileostomy; * Patients with or without neoadjuvant treatment; * Patient who benefits by medicare system; * Signed and dated informed consent Exclusion Criteria: * Patients with handsewn anastomosis * Patients with perforated rectal cancer or preoperative pelvic sepsis ; * Patients with inflammatory bowel disease; * Patients operated on in emergency ; * Patients with extended-TME or pelvic exenteration; * Pregnancy or breast feeding period * Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study * Persons deprived of liberty or under guardianship
References
Publications (0)
Data not yet available
No reference posted for this study.