Malignant TumorSART cohortNCT04757103
Surgical Approach for Retrorectal Tumors Cohort
An observational study of Malignant Tumor, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aim of the study : To evaluate postoperative outcomes of all surgical approach for retrorectal tumors. Methods : From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- Resection of the retrorectal tumor
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting a retrorectal tumor who underwent surgical excision
Who may be able to join
- Patient presenting a retrorectal tumor
- Surgical procedure between 01/01/2005 and 31/12/2020
Who cannot join
- age < 18 years old
- Patients presenting a rectal tumor
- Patients presenting a rectal duplication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)
Aim of the study :
To evaluate postoperative outcomes of all surgical approach for retrorectal tumors.
Methods :
From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected.
Considering our exlusion criterias, data from XX patients were analyzed. The cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra.
Short and longterm outcomes were compared between the two groups.
Primary outcome :
90 days postoperative morbidity rate
Read the detailed description
Retro-rectal tumors are a group of heterogeneous and rare lesions. The actual incidence has been estimated to be approximately one case per 40,000 admissions. It is most often a benign tumor that affects young women and the origin is congenital in 60% of cases. The most common benign lesion is a tailgut cyst. Chordoma is the most common malignant lesion. They are mostly asymptomatic or pauci-symptomatic. This is why their diagnosis is regularly accidentaly after a morphological examination such as an abdominal ultrasound or a CT scan. MRI is the gold standard for determining the structure of the lesion, its origin, its topography, its extension in relation to adjacent organs, parameters that are essential to define the type of surgery and its approach.
When a retro-rectal tumor is diagnosed, the standard treatment is surgical resection. A biopsy is not helpful if there is no suspicion of a degenerate lesion. Usually, lesions located under the third sacral vertebra (S3) are approached by dorsal transsacrococcygeal, perineal or combined approach (abdominal and perineal approach) while those located above S3 the approach is abdominal (laparotomy or laparoscopy). As these lesions are, in the majority of cases, benign, the functional impact of surgery is essential. Based on our experience in minimally invasive surgery and in particular in retro-rectal tumors, laparoscopy has become our first-line approach regardless of the location of the lesion compared to S3. Our hypothesis is that the minimally invasive approach is reliable, safe and allows satisfactory histological results to be obtained while limiting postoperative pain and functional sequelae.
- Conditions
- Malignant Tumor
- Being tested
- Resection of the retrorectal tumor
- Keywords
- Retrorectal tumor, Tail gut cyst, Benign tumor, Mini-invasive approach, Open approach, Perineal approach
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection of the retrorectal tumorProcedure or surgery
Surgical resection of the retrorectal mass
| Study group | Role | What they receive |
|---|---|---|
| Above S3 | Lesion located above the third sacral vertebra Receives: Procedure: Resection of the retrorectal tumor | |
| Below S3 | Lesion located below the third sacral vertebra Receives: Procedure: Resection of the retrorectal tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity rate
Postoperative morbidity according to Clavien Dindo
Measured: 90 days
Secondary outcomes (7)
Mortality rate
Mortality rate
Measured: 90 days
Reoperation rate
Any reoperation linked to surgical resection of the retrorectal tumor
Measured: 90 days
Quality of surgical resection
Evaluation of surgical margins according to pathological examination
Measured: 90 days
Conversion to open approach
Conversion to laparotomy in case of mini-invasive approach
Measured: 90 days
Rate of functional outcomes
Evaluation of fecal
Measured: 90 days
Rate of functional outcomes
Evaluation urinary functions
Measured: 90 days
Functional outcomes
Evaluation of sexual functions
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Jan 2021
- Primary completion30 Jan 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier, Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
- Investigators
- Thomas Bardol, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757103
- Sponsor's protocol ID
- RECHMPL21_0093
- Acronym
- SART cohort
- Status last verified
- Nov 2021
- First submitted
- 10 Feb 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)
- ClinicalTrials.gov ID
- NCT04757103
- Acronym / sponsor ID
- SART cohort / RECHMPL21_0093
- Conditions
- Malignant Tumor
- Keywords
- Retrorectal tumor, Tail gut cyst, Benign tumor, Mini-invasive approach, Open approach, Perineal approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier, Centre Hospitalier Universitaire de Nīmes
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 17 Feb 2021 (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.
Aim of the study :
To evaluate postoperative outcomes of all surgical approach for retrorectal tumors.
Methods :
From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected.
Considering our exlusion criterias, data from XX patients were analyzed. The cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra.
Short and longterm outcomes were compared between the two groups.
Primary outcome :
90 days postoperative morbidity rate
Detailed description
Retro-rectal tumors are a group of heterogeneous and rare lesions. The actual incidence has been estimated to be approximately one case per 40,000 admissions. It is most often a benign tumor that affects young women and the origin is congenital in 60% of cases. The most common benign lesion is a tailgut cyst. Chordoma is the most common malignant lesion. They are mostly asymptomatic or pauci-symptomatic. This is why their diagnosis is regularly accidentaly after a morphological examination such as an abdominal ultrasound or a CT scan. MRI is the gold standard for determining the structure of the lesion, its origin, its topography, its extension in relation to adjacent organs, parameters that are essential to define the type of surgery and its approach.
When a retro-rectal tumor is diagnosed, the standard treatment is surgical resection. A biopsy is not helpful if there is no suspicion of a degenerate lesion. Usually, lesions located under the third sacral vertebra (S3) are approached by dorsal transsacrococcygeal, perineal or combined approach (abdominal and perineal approach) while those located above S3 the approach is abdominal (laparotomy or laparoscopy). As these lesions are, in the majority of cases, benign, the functional impact of surgery is essential. Based on our experience in minimally invasive surgery and in particular in retro-rectal tumors, laparoscopy has become our first-line approach regardless of the location of the lesion compared to S3. Our hypothesis is that the minimally invasive approach is reliable, safe and allows satisfactory histological results to be obtained while limiting postoperative pain and functional sequelae.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Above S3 | – | Procedure: Resection of the retrorectal tumorLesion located above the third sacral vertebra |
| Below S3 | – | Procedure: Resection of the retrorectal tumorLesion located below the third sacral vertebra |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting a retrorectal tumor who underwent surgical excision
Key inclusion criteria (2 listed)
- Patient presenting a retrorectal tumor
- Surgical procedure between 01/01/2005 and 31/12/2020
Key exclusion criteria (3 listed)
- age < 18 years old
- Patients presenting a rectal tumor
- Patients presenting a rectal duplication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection of the retrorectal tumorSurgical resection of the retrorectal mass | Procedure or surgery | Above S3, Below S3 |
Primary outcome
Postoperative morbidity rate
Time frame: 90 days
Postoperative morbidity according to Clavien Dindo
7 secondary outcomes
Mortality rate
Time frame: 90 days
Reoperation rate
Time frame: 90 days
Quality of surgical resection
Time frame: 90 days
Conversion to open approach
Time frame: 90 days
Rate of functional outcomes
Time frame: 90 days
Rate of functional outcomes
Time frame: 90 days
Functional outcomes
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
Thomas Bardol study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morbidity rate (time frame: 90 days). 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 15 Nov 2021.