Clinical trial NCT04757103: Surgical Approach for Retrorectal Tumors Cohort
Official title: Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Tumor
Keywords: Retrorectal tumor
Tail gut cyst
Benign tumor
Mini-invasive approach
Open approach
Perineal approach
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
name: Centre Hospitalier Universitaire de Nīmes
First posted: 2021-02-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting a retrorectal tumor who underwent surgical excision

Brief 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.

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.

Eligibility criteria: Inclusion criteria:

* Patient presenting a retrorectal tumor
* Surgical procedure between 01/01/2005 and 31/12/2020

Exclusion criteria:

* age \< 18 years old
* Patients presenting a rectal tumor
* Patients presenting a rectal duplication

Primary outcomes:
measure: Postoperative morbidity rate
timeFrame: 90 days
Secondary outcomes:
measure: Mortality rate
timeFrame: 90 days
measure: Reoperation rate
timeFrame: 90 days
measure: Quality of surgical resection
timeFrame: 90 days
measure: Conversion to open approach
timeFrame: 90 days
measure: Rate of functional outcomes
timeFrame: 90 days
measure: Rate of functional outcomes
timeFrame: 90 days
measure: Functional outcomes
timeFrame: 90 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Thomas Bardol
role: STUDY_DIRECTOR
References: