EndometriosisRSRES_NERVSPNCT05682690
Laparoscopic Eradication of Deep Endometriosis With Nerve-sparing Rectosigmoid Segmental Resection (RSRES_NERVSP)
An observational study of Endometriosis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
This is a single-center, retrospective case-control study. All consecutive women who underwent classic and nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022 will be included. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- How many people
- 3,072 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 10 Oct 2022
- 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 years and older
- Women only
- Adult, Older adult
Study population: Patients with rectosigmoid endometriosis who underwent classic or nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022
Who may be able to join
- consecutive women who underwent classic and nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022
- age more than 18 years.
Who cannot join
- diagnosis of other/concomitant preoperative and/or postoperative medical or surgical conditions altering pelvic organ function (i.e. multiple sclerosis, irritable bowel syndrome);
- age <18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Eradication of Deep Endometriosis With Nerve-sparing Rectosigmoid Segmental Resection: a Comparative Retrospective Analysis (RSRES_NERVSP)
This is a single-center, retrospective case-control study. All consecutive women who underwent classic and nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022 will be included. In the majority of cases classic segmental rectosigmoid resection was done between January 2005 and December 2010. Nerve-sparing segmental rectosigmoid resection has been increasingly employed since January 2011 until now. Preoperative (anamnestic, physical objective, and ultrasonographic data), surgical and postoperative data of the patients included in this study will be analyzed. In particular, postoperative data will be obtained by analyzing reports of follow-up visits, which are routinely done at our institution at 1, 6, 12 months and then every year following the surgical procedures.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients having intraoperative complications
Number of patients having intraoperative complications evaluated by surgical data stored in the hospital medical electronic register
Measured: During the surgical procedures
Number of patients having short-term postoperative complications
Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits
Measured: 3 months after the surgical procedures
Number of patients having middle-term postoperative complications
Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits
Measured: 6 months after the surgical procedures
Number of patients having long-term postoperative complications
Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits
Measured: 12 months after the surgical procedures
Secondary outcomes (4)
Intraoperative blood loss (ml)
Intraoperative blood loss (ml) evaluated by surgical data stored in the hospital medical electronic register
Measured: During the surgical procedures
Number of patients having an intraoperative laparotomic conversion
Intraoperative blood loss (ml) evaluated by surgical data stored in the hospital medical electronic register
Measured: During the surgical procedures
Operative time (min)
Operative time (min) evaluated by surgical data stored in the hospital medical electronic register
Measured: During the surgical procedures
Number of patients undergoing a concomitant additional surgical procedure
Number of patients undergoing a concomitant additional surgical procedure evaluated by surgical data stored in the hospital medical electronic register
Measured: During the surgical procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Oct 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- 3,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcello Ceccaroni, Principal investigator, IRCCS Sacro Cuore Don Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682690
- Sponsor's protocol ID
- 2022-ZF
- Acronym
- RSRES_NERVSP
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ceccaroni M, Ceccarello M, Raimondo I, Roviglione G, Clarizia R, Bruni F, Mautone D, Manzone M, Facci E, Rettore L, Rossini R, Bertocchi E, Barugola G, Ruffo G, Barra F. "A Space Odyssey" on Laparoscopic Segmental Rectosigmoid Resection for Deep Endometriosis: A Seventeen-year Retrospective Analysis of Outcomes and Postoperative Complications among 3050 Patients Treated in a Referral Center. J Minim Invasive Gynecol. 2023 Aug;30(8):652-664. doi: 10.1016/j.jmig.2023.04.005. Epub 2023 Apr 26.
PubMed 37116746
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Eradication of Deep Endometriosis With Nerve-sparing Rectosigmoid Segmental Resection: a Comparative Retrospective Analysis (RSRES_NERVSP)
- ClinicalTrials.gov ID
- NCT05682690
- Acronym / sponsor ID
- RSRES_NERVSP / 2022-ZF
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,072 participants (actual)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 12 Jan 2023 (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.
This is a single-center, retrospective case-control study. All consecutive women who underwent classic and nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022 will be included. In the majority of cases classic segmental rectosigmoid resection was done between January 2005 and December 2010. Nerve-sparing segmental rectosigmoid resection has been increasingly employed since January 2011 until now. Preoperative (anamnestic, physical objective, and ultrasonographic data), surgical and postoperative data of the patients included in this study will be analyzed. In particular, postoperative data will be obtained by analyzing reports of follow-up visits, which are routinely done at our institution at 1, 6, 12 months and then every year following the surgical procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with rectosigmoid endometriosis who underwent classic or nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022
Key inclusion criteria (2 listed)
- consecutive women who underwent classic and nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022
- age more than 18 years.
Key exclusion criteria (2 listed)
- diagnosis of other/concomitant preoperative and/or postoperative medical or surgical conditions altering pelvic organ function (i.e. multiple sclerosis, irritable bowel syndrome);
- age <18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients having intraoperative complications
Time frame: During the surgical procedures
Number of patients having intraoperative complications evaluated by surgical data stored in the hospital medical electronic register
Number of patients having short-term postoperative complications
Time frame: 3 months after the surgical procedures
Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits
Number of patients having middle-term postoperative complications
Time frame: 6 months after the surgical procedures
Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits
Number of patients having long-term postoperative complications
Time frame: 12 months after the surgical procedures
Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits
4 secondary outcomes
Intraoperative blood loss (ml)
Time frame: During the surgical procedures
Number of patients having an intraoperative laparotomic conversion
Time frame: During the surgical procedures
Operative time (min)
Time frame: During the surgical procedures
Number of patients undergoing a concomitant additional surgical procedure
Time frame: During the surgical procedures
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 17 Jan 2023.
- Derived from this study: PubMed 37116746Ceccaroni M, Ceccarello M, Raimondo I, Roviglione G, Clarizia R, Bruni F, Mautone D, Manzone M, Facci E, Rettore L, Rossini R, Bertocchi E, Barugola G, Ruffo G, Barra F. "A Space Odyssey" on Laparoscopic Segmental Rectosigmoid Resection for Deep Endometriosis: A Seventeen-year Retrospective Analysis of Outcomes and Postoperative Complications among 3050 Patients Treated in a Referral Center. J Minim Invasive Gynecol. 2023 Aug;30(8):652-664. doi: 10.1016/j.jmig.2023.04.005. Epub 2023 Apr 26.
- Individual participant dataSharing planned: Undecided
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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.
Marcello Ceccaroni principal investigator
IRCCS Sacro Cuore Don Calabria
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 Endometriosis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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 2 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 17 Jan 2023. 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 Italy. 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?
Number of patients having intraoperative complications (time frame: During the surgical procedures). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682690, which also lists 1 linked publication.
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 17 Jan 2023.