Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT04757103
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2021-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Approach for Retrorectal Tumors Cohort
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Surgical Approach for Retro-rectal Tumors: a Retrospective Bicentric Cohort (SART Cohort)
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SART cohort
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: