Rectal CancerOASISNCT07146334
Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)
An observational study of Rectal Cancer and Surgery Indication, run by Bordeaux Colorectal Institute at 15 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Surgery Indication
- How many people
- 400 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Sep 2025to Sep 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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;
Show all 9Show fewer
- Patients with or without neoadjuvant treatment;
- Patient who benefits by medicare system;
- Signed and dated informed consent
Who cannot join
- 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
Trial locations and contacts
15 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Hélène HMM MAILLOU-MARTINAUD, CRA contact
15 sites in 6 countries
France8 sites
CHU de Besançon
Besançon, 25030
Zaher LAKKIS, + 33 ( 0 ) 381668166, zlakkis@chu-besancon.fr
Zaher LAKKIS
Bordeaux Colorectal Institute
Bordeaux, 33 000
Quentin QD DENOST, PupH, + 33 (0)5 47 50 15 75, q.denost@bordeaux-colorectal-institute.fr
Hélène HMM MAILLOU-MARTINAUD, CRA, h.maillou.martinaud@bordeaux-colorectal-institute.fr
Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, 94 270
Antoine BROUQUET, +33 (0)145213472, antoine.brouquet@aphp.fr
Antoine BROUQUET
CHU de Lyon
Lyon, 69 495
Eddy COTTE, + 33 (0) 4 78 86 13 85, eddy.cotte@chu-lyon.fr
Eddy COTTE
Gp Hospitalier Diaconesses Croix St Simon
Paris, 75 020
Alain VALVERDE, +33 (0)1 44 64 20 90, AValverde@hopital-dcss.org
Alain VALVERDE
Hôpital Européen Georges Pompidou APHP
Paris, 75012
Mehdi KAROUI, +33 (0)1 56 09 35 34, mehdi.karoui@aphp.fr
Mehdi KAROUI
Hôpital Saint Antoine APHP
Paris, 75012
Jérémie LEFEVRE, +33 (0) 1 49 28 26 87, jeremie.lefevre@aphp.fr
Jérémie LEFEVRE
Hôpital Charles Nicolle
Rouen, 76 031
Jean-Jacques TUECH, jean-jacques.tuech@chu-rouen.fr
Jean-Jacques TUECH
Canada2 sites
Hôpital Universitaire McGill
Montreal
Larry LEE, larry.lee@mcgill.ca
Larry LEE
CHU de Quebec
Québec
Francois LETARTE, 418 525-4162, francois.letarte.med@ssss.gouv.qc.ca
Spain2 sites
Hôpital General universitaire Madrid
Madrid
Patricia TEJEDOR, +34 91 5868348, patricia.tejedor@hotmail.com
Patricia TEJEDOR
Hôpital Universitaire de Vigo
Vigo
Vincenzo VIGORITA, +34 ext. +34986811111, v.vigorita@gmail.com
Vincezo VIGORITA
Belgium1 site
Hôpital Universitaire de Belgique
Leuven
André D'Hoore, +32 16 34 48 50, andre.dhoore@uzleuven.be
André D'HOORE
China1 site
Hôpital Universitaire de Shanghai
Shanghai
MinHua FHENG, fqy198921@163.com
MinHua FHENG
Italy1 site
Policlinique Universitaire Gemelli
Roma
Flavio TIRELLI, +39 06 8881.8881, flavio.tirelli@policlinicogemelli.it
Flavio TIRELLI
About this study
Official title: Low Powered Colorectal Anastomosis After Rectal Excision : An Exploratory, Observational, Prospective, IDEAL Stage 2b International Cohort Study (OASIS)
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.
Read the detailed description
There are a variety of available anastomotic techniques to facilitate restorative surgery following total mesorectal excision (TME) for rectal cancer. However, there is no good quality evidence demonstrating the superiority of any single technique with regards to the potential sequalae of restorative surgery including anastomotic leakage and functional impact. Double-stapled anastomotic technique (DST) for colorectal anastomosis is the most widely used technique worldwide. An alternative to DST is the hand-sewn coloanal anastomotic (CAA) technique, which is traditionally reserved for patients with ultralow rectal tumours requesting restorative surgery or in cases of technical difficulties whereby a low colorectal anastomosis is converted to a coloanal anastomosis. More recently, the Transanal Transection and Single Staple anastomosis (TTSS) technique has been described. The TTSS technique has the potential to mitigate the difficulties encountered with DST and the potential complications and long-term functional sequalae encountered with handsewn anastomosis. Moreover, powered mechanical circumferential staplers represent a significant advancement in colorectal surgery, particularly in performing anastomosis following rectal excision. These devices are designed to provide consistent staple formation and controlled tissue compression, reducing the variability associated with manual stapling.
AL has a significant impact on clinical, patient-reported, and oncological outcomes. To mitigate the impact of AL a diverting stoma is routinely used to protect the distal anastomosis and facilitate anastomotic healing, with these stomas reversed once the integrity and patency of the distal anastomosis is confirmed. However, there is a significant complication profile associated with the routine use of diverting stomas. Through the incorporation of appropriate pre-operative risk stratification and careful post-operative surveillance a selective stoma strategy is associated with good clinical and functional outcomes.
The use of Double-stapled anastomotic technique (DST) or Transanal Transection Single-Stappled (TTSS) by laparoscopic or robotic approach, using or not a defunctionning stoma could not be separately tested in randomized trial.
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.
- Conditions
- Rectal Cancer, Surgery Indication
- Keywords
- rectal cancer, Transanal Transection and Single Staple anastomosis (TTSS), Double-stapled anastomotic (DS), mechanical anastomosis, rectal surgery, anastomotic leakage
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the surgery to one month
Secondary outcomes (11)
Overall morbidity and mortality rates at 1 month
Postoperative morbidity and mortality according Clavien-Dindo classification at 1 month
Measured: At 1 month after the end of the surgery
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;
Measured: At 12 month after the end of the surgery
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
Measured: At 1, 6 and 12 months after rectal surgery
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.
Measured: At 1,6 and 12 months after rectal surgery
Qualiy of life with EQ5D-5L
Mean Score of the EQ-5D-5L Quality of Life The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The questionnaire is a self-report survey that measures quality of life across 5 domains: : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
- The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, numbered from 0 to 100. ( 100 means "the best health you can imagine" and 0 means "the worst health you
Measured: At 1, 6 and 12 months after rectal surgery
Digestive function with LARS score
The LARS questionnaire (low anterior resection score) evaluates bowel function. Five questions regarding incontinence for flatus and liquid stools, frequency, clustering and urgency for defecation are taken into account. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points).
Measured: At 1, 6 and 12 months after rectal surgery
Anal Incontinence with Wexner score ( or Vaizey score)
The WEXNER score assesses the importance of anal incontinence, it varies from 0 to 20, where 20 corresponding to total anal incontinence
The Vaizey score assesses the importance of anal incontinence score from 0-28 where 0 means better outcomes
Measured: At 1,6 and 12 months after rectal surgery
Female Sexual Function Index (FSFI) scale scores
Measured in female patients. The Female Sexual Function Index (FSFI) is a 19-item self-report inventory designed to assess female sexual function. It comprises six domains: desire, arousal ,lubrication orgasm, satisfaction, pain. The maximum score for each domain is 6.0, obtained by summing item responses and multiplying by a correction factor. The total composite sexual function score is a sum of domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0.
Measured: At 1, 6 and 12 months after rectal surgery
International Index of Erectile Function (IIEF)-5
Measured in male patients
IIEF assessment assesses to a limit the psychosexual background and the partner relationship, both considered important factors in the presentation of male sexual dysfunction.
Scores of 0 to 5 are awarded to each of the 15 questions, then the scores are interpreted in the view of the5 domains from the original study.
Domain A Erectile Function Domain B Orgasmic Function Domain C Sexual Desire Domain D Intercourse Satisfaction Domain E Overall Satisfaction
Measured: At 1,6 and 12 months after rectal surgery
International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life.
Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom.
The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Measured: At 1, 6 and 12 months after surgery
Predictive factors for anastomotic fistula
To identify predictive factors of anastomotic fistula from the surgery to 12 months
Comparison of the clinical and perioperative data . The differences in proportions will be compared.
Measured: From the surgery to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Bordeaux Colorectal Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146334
- Sponsor's protocol ID
- B.C.I. 2025/01
- Acronym
- OASIS
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data(IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Powered Colorectal Anastomosis After Rectal Excision : An Exploratory, Observational, Prospective, IDEAL Stage 2b International Cohort Study (OASIS)
- ClinicalTrials.gov ID
- NCT07146334
- Acronym / sponsor ID
- OASIS / B.C.I. 2025/01
- Conditions
- Rectal Cancer, Surgery Indication
- Keywords
- rectal cancer, Transanal Transection and Single Staple anastomosis (TTSS), Double-stapled anastomotic (DS), mechanical anastomosis, rectal surgery, anastomotic leakage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Bordeaux Colorectal InstituteUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are a variety of available anastomotic techniques to facilitate restorative surgery following total mesorectal excision (TME) for rectal cancer. However, there is no good quality evidence demonstrating the superiority of any single technique with regards to the potential sequalae of restorative surgery including anastomotic leakage and functional impact. Double-stapled anastomotic technique (DST) for colorectal anastomosis is the most widely used technique worldwide. An alternative to DST is the hand-sewn coloanal anastomotic (CAA) technique, which is traditionally reserved for patients with ultralow rectal tumours requesting restorative surgery or in cases of technical difficulties whereby a low colorectal anastomosis is converted to a coloanal anastomosis. More recently, the Transanal Transection and Single Staple anastomosis (TTSS) technique has been described. The TTSS technique has the potential to mitigate the difficulties encountered with DST and the potential complications and long-term functional sequalae encountered with handsewn anastomosis. Moreover, powered mechanical circumferential staplers represent a significant advancement in colorectal surgery, particularly in performing anastomosis following rectal excision. These devices are designed to provide consistent staple formation and controlled tissue compression, reducing the variability associated with manual stapling.
AL has a significant impact on clinical, patient-reported, and oncological outcomes. To mitigate the impact of AL a diverting stoma is routinely used to protect the distal anastomosis and facilitate anastomotic healing, with these stomas reversed once the integrity and patency of the distal anastomosis is confirmed. However, there is a significant complication profile associated with the routine use of diverting stomas. Through the incorporation of appropriate pre-operative risk stratification and careful post-operative surveillance a selective stoma strategy is associated with good clinical and functional outcomes.
The use of Double-stapled anastomotic technique (DST) or Transanal Transection Single-Stappled (TTSS) by laparoscopic or robotic approach, using or not a defunctionning stoma could not be separately tested in randomized trial.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: From the surgery to one month
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.
11 secondary outcomes
Overall morbidity and mortality rates at 1 month
Time frame: At 1 month after the end of the surgery
The rate of anastomotic leakage at 6 and 12 months after rectal surgery;
Time frame: At 12 month after the end of the surgery
Quality of life with QLQ C30 questionnaire
Time frame: At 1, 6 and 12 months after rectal surgery
Quality of life with QLQ CR29 questionnaire
Time frame: At 1,6 and 12 months after rectal surgery
Qualiy of life with EQ5D-5L
Time frame: At 1, 6 and 12 months after rectal surgery
Digestive function with LARS score
Time frame: At 1, 6 and 12 months after rectal surgery
Anal Incontinence with Wexner score ( or Vaizey score)
Time frame: At 1,6 and 12 months after rectal surgery
Female Sexual Function Index (FSFI) scale scores
Time frame: At 1, 6 and 12 months after rectal surgery
International Index of Erectile Function (IIEF)-5
Time frame: At 1,6 and 12 months after rectal surgery
International Prostate Symptom Score (IPSS)
Time frame: At 1, 6 and 12 months after surgery
Predictive factors for anastomotic fistula
Time frame: From the surgery to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data(IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hélène HMM MAILLOU-MARTINAUD, CRA contact
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Surgery Indication, run by Bordeaux Colorectal Institute at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Canada, Spain, Belgium, China and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quentin QD DENOST, Prof (+ 33 (0)5 47 50 15 75, q.denost@bordeaux-colorectal-institute.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From the surgery to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.