Surgical Approach for Retrorectal Tumors Cohort

Malignant Tumor Clinical Trial

— SART cohort  

Official title:

Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757103
• Other study ID #: RECHMPL21_0093
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 1, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Procedure:
• Resection of the retrorectal tumor
Surgical resection of the retrorectal mass

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre Hospitalier Universitaire de Nimes, Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity rate	Postoperative morbidity according to Clavien Dindo	90 days
Secondary	Mortality rate	Mortality rate	90 days
Secondary	Reoperation rate	Any reoperation linked to surgical resection of the retrorectal tumor	90 days
Secondary	Quality of surgical resection	Evaluation of surgical margins according to pathological examination	90 days
Secondary	Conversion to open approach	Conversion to laparotomy in case of mini-invasive approach	90 days
Secondary	Rate of functional outcomes	Evaluation of fecal	90 days
Secondary	Rate of functional outcomes	Evaluation urinary functions	90 days
Secondary	Functional outcomes	Evaluation of sexual functions	90 days