IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Location contact
Diego Raimondo, MD
CONTACT
Diego Raimondo, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06826378
Impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis undergoing either a totally intracorporeal or extracorporeal procedure
Trial opening soon.
Get Notified18 year–54 year
Female
Observational
Bologna, 40138, Italy
Diego Raimondo, MD
CONTACT
Diego Raimondo, MD
PRINCIPAL_INVESTIGATOR
Surgery is the treatment of choice for deep endometriosis with bowel involvement and endometriosis nodules will be treated by segmental resection and subsequent anastomosis packing. Anastomosis packing with a totally intracorporeal approach may be a successful solution to reduce some of the complications after discoid or segmental resection with conventional laparotomic approach for extracorporeal anastomosis.
Setting up the colorectal anastomosis with a totally intracorporeal approach represents a surgical method that has been recently introduced but is already approved in terms of safety and reproducibility. However, experience with this technique is currently limited and there is no established consensus regarding patient suitability or data on longer-term outcomes. New studies are therefore needed to further validate the technique and to fully assess its long-term benefits resulting in increased quality of life for operated patients or to identify any associated complications.
The aim of the study is therefore to describe the impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis who underwent either a totally intracorporeal or extracorporeal procedure. In addition, the aim is to detect any differences in the duration of the operating time, compare the duration of the postoperative hospital stay and determine the success rate of the totally intracorporeal procedure
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During the preoperative evaluation and at 3 months after surgery as part of the postoperative follow-up visit
Evaluation by scoring the validated Low Anterior Resection Syndrome score questionnaire
Time frame: During surgery
Total operating time measured in minutes
Time frame: From date of surgery until the discharge (0-30 days)
Measurement of hospitalisation time after surgery
Time frame: At 3 months after surgery
Number of successfully completed operations out of the total number of operations performed with a fully intracorporeal approach. The success of the intervention is established intraoperatively by performing hydropneumatic tests of the integrity of the anastomosis and during the operative course by assessing the possible occurrence of complications
Time frame: At 3 months after surgery
Number of operations in which one (or more) of the intra-operative complications occurred out of the total number of operations performed with a totally intracorporeal approach
Time frame: Within 3 months of surgery
Number of operations in which one (or more) of the post-operative complications described above occurred out of the total number of operations performed
Contact information is provided by the study sponsor or research team.
Diego Raimondo, MD
CONTACT
Stefano Ferla, MD
CONTACT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Observational Study Between Patients Undergoing Total Intracorporeal Anastomosis Or Extracorporeal Anastomosis After Segmental Resection For Deep Endometriosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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